FR3099982A1 - SUBJECT PHYSIOLOGICAL SIGNALS TRACKING KIT - Google Patents

Abstract

The present invention relates to a set for monitoring the physiological signals of a subject (1) for the diagnosis or monitoring of sleep disorders comprising: a cap (2) capable of being worn on the subject's head, comprising: a brain electrical activity sensor (21), an eye movement sensor (22), and a masticatory and submental muscle electrical activity sensor (23); an undershirt (3) suitable for being worn on the chest of the subject, comprising a sensor of electrical activity of the heart muscle (31), a respiration sensor (32), a sensor of the air flow through the nostrils ( 33) and a subject's torso motion and position sensor (34), and a sensor for sounds resulting from snoring from the subject's rib cage (35); a sensor for the electrical activity of the leg muscles (41). Abstract figure: Figure 1

Description

SET FOR MONITORING THE PHYSIOLOGICAL SIGNALS OF A SUBJECT

The present invention relates to a device for monitoring a plurality of physiological activities of a subject during sleep. In particular, the present invention relates to a device comprising at least one garment suitable for being worn by a subject and allowing the monitoring of the physiological activities of said subject. Said device is in particular configured to allow the diagnosis or monitoring of sleep disorders.

Polysomnography consists of recording several physiological variables during the patient's sleep in order to diagnose certain sleep-related disorders, including, for example, sleep apnea. More specifically, a conventional polysomnography examination includes a plurality of means of measurement such as for example an electroencephalogram, an electrooculogram, an electromyogram, an electrocardiogram, a measurement of oxygen saturation and breathing through the mouth and nostrils , respiratory effort measurements, snoring measurements, and actimetry.

Although widely used, these devices consist of a plurality of measuring means. These are very bulky, uncomfortable and complex to handle, requiring the intervention of a professional for their implementation on a person and therefore hospitalization. It is estimated that there are about 80 sleep-related diseases and that 20% of patients remain misdiagnosed.

It is therefore necessary to find a way to design a device capable of measuring a wider range of physiological activities of the subject by simplifying and accelerating their implementation before sleep and also to integrate the measuring means into the device so as to obtain a more comfortable and ergonomic device for the subject. This would allow a simpler polysomnography examination, and a more reliable diagnosis and/or monitoring of the subject's sleep disorders.

It is known from the prior art, in particular via European patent application EP 2 767 235, a device for a polysomnography examination based on a cap comprising an electroencephalogram, an electrooculogram, an electromyogram, a sensor for measuring the oxygen saturation in the blood and a breathing sensor through the mouth and the nostrils coupled with a support located on the subject's torso comprising an electrocardiogram and a breathing sensor. Said device is equipped with a processor which generates a polysomnogram from the signals recorded during the sleep of the subject.

However, this device only makes it possible to monitor a limited number of the physiological activities of the subject. Indeed, it does not take into account, for example, the muscular activity of the upper and/or lower limbs, which allows the diagnosis of certain sleep disorders such as restless leg syndrome. In addition, the measuring means that are part of the device are not integrated into an ergonomic assembly.

The object of the present invention is therefore to provide a device for monitoring a plurality of physiological activities of a subject making it possible to remedy the major drawbacks of the prior art. In particular, the present invention makes it possible to diagnose a wider range of diagnosable sleep disorders by increasing the number of physiological parameters measured, by integrating them into a textile that is simple to implement and by allowing the fine coupling between them of the multiple signals. physiological for a better interpretation of the markers in the pathology of the patient.

SUMMARY

The present invention relates to a set for monitoring the physiological signals of a subject for the diagnosis or monitoring of sleep disorders comprising:

• a cap adapted to be worn on the head of the subject, comprising: a cerebral electrical activity sensor, an eye movement sensor and an electrical activity sensor of the masticatory and submental muscles;
• an undershirt adapted to be worn on the chest of the subject, comprising an electrical activity sensor of the heart muscle, a respiration sensor at the level of the thorax and at the level of the stomach, a sensor of the air flow through the nostrils and a sensor of movement and position of the subject's chest, and a sensor of sounds resulting from snoring;
• a sensor of the electrical activity of the leg muscles.

According to one embodiment, the cap of the assembly further comprises a head movement and positioning sensor.

According to one embodiment, the assembly further comprises a blood oxygen saturation sensor.

According to one embodiment, the assembly further comprises an acquisition means configured to acquire in a synchronized manner the signals measured by said measuring means.

According to one embodiment, the assembly further comprises means for transmitting the electrical signals acquired by the acquisition means to a signal processing means.

According to one embodiment, the respiration sensor at the level of the thorax and at the level of the belly is an inductive sensor.

Advantageously, the integration of several sensors in textile clothing offers greater comfort for the subject who, during a polysomnography examination, must wear the assembly for a period ranging from 4 hours (during a routine follow-up) at 48 hours (in the case of a first diagnosis). The high comfort makes it possible to have a subject's sleep that is more representative of reality since the subject's sleep is less disturbed by the presence of instruments or cables.

According to one embodiment, the undershirt of the assembly comprises a first mechanical and electrical connection element and the pants comprise at least one second mechanical and electrical connection element configured to be mechanically and electrically connected with a first connection element mechanical and electrical.

According to one embodiment, the sensor of the electrical activity of the muscles of the legs is included in pants able to be worn on the legs of the subject.

The present invention further relates to a cap for an assembly as described above, comprising:

• a cerebral electrical activity sensor;
• an eye movement sensor;
• a sensor of electrical activity of the masticatory and submental muscles.

According to one embodiment, the cerebral electrical activity sensor comprises at least six electrodes.

According to one embodiment, the eye movement sensor uses at least two electrodes or an infrared light optical sensor.

According to one embodiment, the cap further comprises a blood oxygen saturation sensor capable of being positioned in contact with the subject's forehead.

According to one embodiment, the cap for the set further includes a head movement and positioning sensor.

The present invention further relates to an undershirt for an ensemble as described above, comprising:

• a heart muscle electrical activity sensor;
• a respiration sensor at chest level and at belly level;
• an airflow sensor through the nostrils;
• a motion and position sensor of the subject's chest
• a sound sensor resulting from snoring.

According to one embodiment, the undershirt further comprises a blood oxygen saturation sensor.

According to one embodiment, the undershirt further comprises a sensor of the air flow generated by the mouth of the subject.

The present invention further relates to pants for an assembly as described above, comprising an electrical activity sensor of the leg muscles.

Advantageously, the specific arrangement of the sensors on the textile garments allows easy and correct positioning of said sensors even for health personnel not trained in the fitting of polysomnography sensors.

DEFINITIONS

In the present invention, the terms below are defined as follows:

• By “ at the level of ” we mean at the height of. Thus, by way of example, a textile capable of being worn at the level of a mastoid process is a garment capable of covering the skin overlying the mastoid process.
• By " textile electrodes " is meant electrodes consisting of conductive threads or threads covered with a conductive material woven, knitted, embroidered, deposited or printed in the garment. According to one embodiment, the wire is a metal wire or a wire covered with a metal coating, in particular, the wire can be a silver wire or a wire covered with silver. According to one embodiment, the thread is a carbon thread or a thread comprising conductive particles such as nanotubes or metallic nanoparticles. According to one embodiment, the wire is coated with an intrinsically conductive organic material, such as polyaniline.
• By “ masticatory muscles ” is meant the muscles allowing the movement of the mandible during mastication and thus the raising or lowering of the jaw.
• By " cap " is meant a textile garment worn directly on the skin, where appropriate in contact with hair such as hair, covering at least part of the scalp of the subject, it includes in particular the cap and the headband.
• By " trousers " is meant a textile garment worn next to the skin, where appropriate in contact with hair, covering the lower part of the subject's body, the two legs being covered separately; it encompasses the pants with the leg stopping between mid-thigh and the ankle.
• By " undershirt " is meant a textile garment worn next to the skin, if necessary in contact with hair, covering the subject's bust, it includes the undershirt, the T-shirt or the tank top with long sleeves, short-sleeved or sleeveless.
• By “ signal processing means ” is meant at least one microprocessor, at least one integrated circuit, at least one electronic card or at least one microcontroller. This signal processing means may comprise an assembly comprising an on-board computer and external calculation means such as a mobile device and remote servers.

The present invention relates to a set for monitoring the physiological signals of a subject for the diagnosis or monitoring of sleep disorders requiring the measurement of a plurality of signals generated by the physiological activities of the subject. A sleep disorder (somnipathy) is a medical disorder that may have physiological, environmental or behavioral causes (related to an individual's sleep patterns).

The set for monitoring the physiological signals of a subject for the diagnosis or monitoring of sleep disorders according to the present invention comprises in particular a cap suitable for being worn on the subject's head, comprising a cerebral electrical activity sensor, a eye movement sensor and an electrical activity sensor of the muscles under the mandible or the muscles of the chin and an undershirt adapted to be worn on the chest of the subject, comprising a sensor of electrical activity of the heart muscle, a respiration sensor at the level of the thorax and at the level of the belly, a sensor of sounds resulting from snoring coming from the subject, a sensor of the air flow through the nostrils and a sensor of the movement and position of the subject's bust and an activity sensor electricity of the leg muscles.

In one embodiment, the assembly further includes a blood oxygen saturation sensor. This sensor can be located on the cap or on the undershirt. According to one embodiment, the blood oxygen saturation sensor is an optical sensor in contact with the skin. According to one embodiment, the blood oxygen saturation sensor is an oximeter located on the cap so as to be positioned in or on an ear or on the skin at the level of the subject's neck or forehead when the cap is worn by the subject. According to an alternative embodiment, the blood oxygen saturation sensor is an oximeter located on the undershirt on the skin at the level of the subject's neck, arm, hands, thorax or back.

In one embodiment, the undershirt further includes an arm muscle electrical activity sensor. This sensor can be in surface electromyography.

In one embodiment, the assembly comprises pants adapted to be worn on the legs of the subject comprising the sensor of the electrical activity of the muscles of the legs.

According to one embodiment, the assembly further comprises an acquisition means configured to acquire in a synchronized manner the signals measured by said measuring means. A synchronized acquisition of these signals allows a comparison at the same date or at the same time t of the various signals. The acquisition means comprises an electronic circuit.

According to one embodiment, the assembly according to the invention also comprises a body temperature sensor. In this embodiment, the acquisition means is also configured to synchronously acquire the signals measured by the body temperature sensor. According to one embodiment, the body temperature sensor is included in the cap, the undershirt or the pants.

According to one embodiment, the assembly according to the invention also comprises an external electromagnetic disturbance sensor. According to one embodiment, the external electromagnetic disturbance sensor is included in the cap or undershirt. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the external electromagnetic disturbance sensor, and the signal processing means is also configured to detect among the signals measured by the cerebral electrical activity the signals measured by the sensor of external electromagnetic disturbances. This detection uses a decomposition into independent components and principal components (ICA and PCA) or else into correlation analyzes known to those skilled in the art. According to one embodiment, the signal processing means is also configured to remove, among the signals measured by the cerebral electrical activity sensor, the signals measured by the electromagnetic disturbance sensor. This removal can be done using a decomposition into independent components and principal components (ICA and PCA). According to one embodiment, the sensor of external electromagnetic disturbances is included in the cap, the undershirt or the pants.

In one embodiment, the cap of the assembly includes a plurality of conductive electrodes capable of measuring cerebral electrical activity. According to one embodiment, said conductive electrodes are conductive electrodes not requiring gel during implementation, preferably said conductive electrodes are dry conductive electrodes. According to one embodiment, the plurality of conductive electrodes capable of measuring cerebral electrical activity are conductive electrodes comprising a gel, in particular an ionic gel. According to one embodiment, the cerebral electrical activity sensor is a plurality of capacitive electrodes. According to one embodiment, the textile electrodes are not purely capacitive. According to an alternative embodiment, the electrodes comprise textile electrodes woven, knitted, embroidered, deposited or printed in, under or on said textile garments.

According to one embodiment, the plurality of conductive electrodes capable of measuring cerebral electrical activity are arranged according to the international 10/20 system. Alternatively, the plurality of conductive electrodes capable of measuring cerebral electrical activity can be arranged according to any other system, such as the 10/10 system or the 10/5 system.

According to one embodiment, the cap of the assembly, able to be worn on the head of the subject and at the level of the masticatory muscles or the submental muscles of the subject, comprises 21 conductive electrodes able to measure the cerebral electrical activity and at least one reference electrode; said conductive electrodes being preferably positioned according to the international 10/20 system.

According to one embodiment, the cerebral electrical activity sensor comprises at least six conductive electrodes and at least one reference electrode. In this embodiment, the six electrodes are arranged according to the international 10/20 or 10/10 system. The locations of the six electrodes were chosen between the locations of the international 10/20 or 10/10 system according to medical prescription as optimal for monitoring sleep stages.

According to an alternative embodiment, the cap of the assembly comprises a plurality of housings capable of receiving a plurality of conductive electrodes capable of measuring cerebral electrical activity.

According to one embodiment, the cap of the assembly suitable for being worn on the subject's head and at the level of the masticatory muscles or the submental muscles of the subject also comprises at least one reference electrode serving as a reference for the electrodes of the cap to measure an electrical potential difference. According to one embodiment, this at least one reference electrode is located on the cap so as to be positioned in the middle of the subject's forehead. According to one embodiment, this at least one reference electrode is located on the cap so as to be positioned at the mastoid process of the subject when the cap is worn by the subject.

According to one embodiment, said reference electrode does not require gel during implementation, preferably said at least one reference electrode is a dry conductive electrode. According to one embodiment, the reference electrode is a textile electrode. According to an alternative embodiment, said reference electrode is a conductive electrode comprising a gel, in particular an ionic gel

In view of the low intensity of the signals of cerebral electrical activity, the signals measured are often "polluted" by parasitic signals, and in particular, the electrical signals emitted by the masticatory muscles, due to their intensities and their proximity to the brain. It is therefore necessary to differentiate the signals of cerebral electrical activity from other parasitic signals in order to allow a reliable analysis of the signals of cerebral electrical activity.

According to one embodiment, the signal processing means of the assembly is therefore also configured to detect, among the signals measured by the cerebral electrical activity sensor, the signals measured by the muscle electrical activity sensor masticators. These signals can then be attenuated in the cerebral electrical signal or enhanced so that the interpreter clearly identifies them as such. This detection uses a decomposition into independent components and principal components (ICA and PCA) or correlation analyzes known to those skilled in the art.

In general, the combined analysis of data recorded by undershirt sensors combined with EEG recordings makes it possible to associate the detection of a respiratory event with the stage of the sleep cycle in which the subject is at the time of detection. The combined analysis of data recorded by the sensors of the undershirt combined with the EEG recordings makes it possible in particular to detect the syndrome of high resistance of the upper airways.

According to one embodiment, the eye movement sensor uses at least two electrodes or an infrared light optical sensor. In the embodiment using the electrodes, the reference electrode of the cerebral electrical activity sensor is also used as a reference electrode for measuring ocular activity.

According to one embodiment, the measurement can be performed by at least three conductive electrodes, comprising a pair of measurement electrodes and a reference electrode. In one embodiment, the electrode of the pair of electrodes allowing the measurement of the movement of the left eye is located on the cap so as to be positioned under the exterior angle of the subject's left eye when the garment The cap-type garment is worn by the subject and the correlated reference electrode is located on the cap so as to be positioned over the subject's left and/or right mastoid when the cap-type garment is worn by the subject. The electrode of the pair of electrodes allowing the measurement of the movement of the right eye is located on the cap so as to be positioned above the exterior angle of the subject's right eye when the cap is worn by the subject. The pairs of electrodes measure ocular activity thanks to the potential difference existing between the cornea and the retina of the eye. According to one embodiment, the pair of measurement electrodes is integrated into the fabric of the cap where the pair of electrodes consists of two gel electrodes attached to the cap by supports, in particular cables. According to one embodiment, the reference electrode is placed on the subject's left and/or right mastoid. Alternatively, the electrode in the FpZ position of the cerebral electrical activity sensor can be used as a reference for the eye movement sensor.

According to one embodiment, the electrodes comprise textile electrodes woven, knitted, embroidered, deposited or printed in, under or on said textile garments. According to one embodiment, the electrodes do not require gel during implementation, preferably said at least one reference electrode is a dry conductive electrode. According to an alternative embodiment, said electrodes are conductive electrodes comprising a gel, in particular an ionic gel.

The eye movement sensor makes it possible in particular to determine the moment in which the subject enters a stage of the sleep cycle, such as for example the stage of paradoxical sleep, which is characterized by rapid eye movements. This embodiment also makes it possible to identify the spurious signals due to eye movements among the signals measured by the cerebral electrical activity sensor. This embodiment also makes it possible to determine involuntary movements of the eyeballs, linked to certain sleep disorders.

In one embodiment, the signal processing means is also configured to detect, among the signals measured by the cerebral electrical activity sensor, the signals measured by the eye movement sensor. This detection uses a decomposition into independent components and principal components (ICA and PCA) or correlation analyzes known to those skilled in the art.

The electrical activity sensor of the masticatory and submental muscles makes it possible in particular to identify muscle atony, characterized by the reduction in tone and contractility of the masticatory and submental muscles, and is typical of the paradoxical phase of sleep. This embodiment also makes it possible to detect bruxism, characterized by an unconscious movement of the masticating apparatus, either by clenching or by lateral movements, then called teeth grinding.

According to one embodiment, the sensor of electrical activity of the masticatory muscles comprises two electrodes. According to one embodiment, the conductive electrode capable of measuring the electrical activity of the masticatory muscles is located on the cap so as to be positioned at the level of the mandible when the cap is worn by the subject. According to this embodiment, the cap comprises at least one textile portion capable of being positioned at the level of the masticatory muscles when the cap is worn by the subject.

According to one embodiment, the cap of the assembly comprises at least two textile portions capable of being positioned at the level of the mandible on either side of the subject's head when the cap is worn by the subject. In one embodiment, the two conductive electrodes capable of measuring the electrical activity of the masticatory muscles are two textile electrodes, each being located in one of the two textile portions. In one embodiment, the two conductive electrodes capable of measuring the electrical activity of the masticatory muscles are two textile electrodes located in the same textile portion. According to one embodiment, said conductive electrodes are conductive electrodes not requiring gel during implementation, preferably said conductive electrodes are dry conductive electrodes.

In one embodiment, the cap of the assembly comprises at least one conductive electrode capable of measuring the electrical activity of submental muscles.

According to one embodiment, the conductive electrode capable of measuring the electrical activity of the submental muscles is located on the cap so as to be positioned at the level of the chin when the cap is worn by the subject. According to this embodiment, the cap comprises at least one textile portion capable of being positioned at the level of the submental muscles when the cap type is worn by the subject. In this embodiment, the conductive electrode capable of measuring the electrical activity of the submental muscles is a textile electrode located in said at least one textile portion. According to an alternative embodiment, said conductive electrodes are conductive electrodes not requiring gel during implementation, preferably said conductive electrodes are dry conductive electrodes.

According to one embodiment, the cap of the assembly further comprises a strap for the chin in which is integrated a sensor of electrical activity of the muscles of the chin. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the sensor of electrical activity of the chin muscles.

According to one embodiment, the cap of the set also includes a head movement and positioning sensor. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the head movement and positioning sensor. These operations are carried out using a 3-axis (accelerometer), 6-axis (accelerometer and gyroscope) or 9-axis (accelerometer, gyroscope and magnetometer) acetimeter (IMU, “inertial motion unit”). According to one embodiment, these signals are then analyzed according to signal processing methods (filtering, integration, thresholding) and classification with respect to models or artificial intelligence software. This analysis is known to those skilled in the art, and results in a classification of the energy expenditure of the subject, knowing his mass, and an estimate of his physical effort. Advantageously, the information concerning the position of the head, combined with the information concerning the position of the bust obtained thanks to the motion and bust position sensor, makes it possible to know the exact position of the subject's body which can impact the quality of breathing during sleep.

According to one embodiment, the cap-type garment suitable for being worn on the subject's head and at the level of the masticatory muscles or submental muscles of the subject also comprises a movement and position sensor of the subject's head. According to one embodiment, the measurement can be performed by an accelerometer and/or actimeter.

According to one embodiment, the cap able to be worn on the head of the subject and at the level of the masticatory muscles of the subject also comprises a body temperature sensor of the subject.

According to one embodiment, the subject cap also includes an electromagnetic radiation sensor.

According to one embodiment, the undershirt of the assembly comprises a plurality of conductive electrodes capable of measuring the electrical activity of the cardiac muscle. According to one embodiment, the undershirt comprises 2, 4, 6, 8, 12 or more conductive electrodes, preferably two, capable of measuring the electrical activity of the cardiac muscle. According to one embodiment, the sensor of the electrical activity of the cardiac muscle comprises a plurality of conductive electrodes that do not require gel during implementation. In one embodiment, the heart muscle electrical activity sensor includes a plurality of dry conductive electrodes. According to one embodiment, the cardiac muscle electrical activity sensor comprises a plurality of capacitive electrodes. According to one embodiment, the conductive electrodes comprise textile electrodes woven, knitted, embroidered, deposited or printed in, under or on said textile garments.

According to one embodiment, a plurality of conductive electrodes are located on the undershirt so as to be positioned at the level of the cardiac muscle when the undershirt is worn by the subject.

According to one embodiment, the undershirt of the assembly also comprises at least one reference electrode serving as a reference for the electrodes of the undershirt in order to measure an electrical potential difference.

According to one embodiment, the breathing sensor at chest level and at stomach level in the undershirt of the assembly comprises at least one textile elastic band, woven, knitted or embroidered on the undershirt-type garment suitable to measure the respiratory activity of the subject. According to one embodiment, said textile elastic band comprises an inductive means making it possible to measure the distance between the rib cage, i.e. the change in diameter of the rib cage. According to one embodiment, the undershirt is able to be worn at the level of the rib cage and comprises a textile elastic band located on the undershirt so as to be positioned at the level of the rib cage when the undershirt is carried by the subject. According to a preferred embodiment, the undershirt is able to be worn on the bust of the subject and comprises a first textile elastic band located on the undershirt so as to be positioned at the level of the rib cage when the garment of the type undershirt is worn by the subject, and a second textile elastic band located on the undershirt so as to be positioned at the level of the navel when the undershirt is worn by the subject.

The sensor of breathing at the level of the thorax and at the level of the belly makes it possible in particular to detect the reduction in amplitude of the respiratory flow and / or the interruption of the respiratory flow, or the phase opposition between the abdominal and thoracic breathing movement linked for example to paradoxical breathing. According to one embodiment, the signal processing means is also configured to monitor the respiratory rhythm and identify a sleep disorder called Cheyne-Stokes respiration, characterized by an abnormal periodic respiratory rhythm which presents a regular alternation of apnea periods. and hyperpnea (increased amplitude breathing).

According to one embodiment, the undershirt of the set further comprises a blood oxygen saturation sensor (oximeter). This embodiment makes it possible in particular to detect the oxygenation of the blood, in fact oxygen desaturation is typical of sleep apnea. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the oxygenation of the blood. According to one embodiment, the blood oxygen concentration sensor is an optical sensor in contact with the skin. According to one embodiment, the blood oxygen concentration sensor is located on the undershirt so as to be positioned on the subject's torso when the undershirt is worn by the subject.

According to one embodiment, the measurement of the airflow through the nostrils is carried out by an exhaled air pressure sensor channeled in nasal cannulas.

According to one embodiment, the undershirt of the set further comprises a sensor for sounds resulting from snoring coming from the subject's nose and/or mouth. This embodiment makes it possible in particular to record the sounds resulting from snoring through the rib cage. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the snoring sound sensor. The sound sensor may be a microphone which is also suitable for recording environmental noises and noise produced by the subject's mouth and/or nose. Such a sound sensor makes it possible in particular to detect catathrenia, which is a rapid eye movement sleep disorder consisting of inspiratory apnea (retention of breath) and an expiratory moan during sleep.

According to one embodiment, the undershirt of the set further comprises an electrical activity sensor of the muscles of the arms. This embodiment makes it possible in particular to detect the muscular movements of the arms occurring, for example, when a subject is suffering from restless limbs syndrome which is a disorder of the nervous system also called Willis-Ekbom disease or when the subject is suffering from nocturnal myoclonus or REM sleep behavior disorder, which causes involuntary and periodic movements of the limbs during sleep or when the subject suffers from insomnia or sleepwalking. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the muscle electrical activity sensor of the arms, and the signal processing means is also configured to detect among the signals measured by the muscle electrical activity sensor signals correlated to predefined movements; especially sudden or jerky movements. This detection can be carried out by an amplitude demodulation technique known to those skilled in the art.

According to one embodiment, the undershirt of the set also includes an electrical activity sensor for the muscles of the forearms (superficial flexor muscle of the fingers and extensor muscle of the fingers) and back (trapezoids). In one embodiment, the measurement can be performed by at least one electrode located at the level of a forearm when the undershirt is worn by the subject. The electrode can be integrated into the fabric of the undershirt comprising long sleeves at the level of a forearm or alternatively, the electrode can be a gel electrode capable of being glued at the level of a forearm from subject.

According to one embodiment, said undershirt of the set comprises a sensor flow of air entering and leaving through the mouth. This embodiment makes it possible in particular to monitor the respiratory rate and detect sleep hypopnea, characterized by a 30% reduction in the respiratory flow, or sleep apnea, characterized by the interruption of the respiratory flow. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the sensor of the flow of air entering and leaving through the mouth.

According to one embodiment, the undershirt of the set also includes a motion and position sensor of the subject's body. According to one embodiment, the measurement can be performed by an accelerometer and/or actimeter.

According to one embodiment, the undershirt of the set also includes a subject's body temperature sensor.

According to one embodiment, the pants of the set further comprise an electrical activity sensor of the leg muscles. This embodiment makes it possible in particular to detect the muscular movements of the legs occurring, for example, when a subject is suffering from restless limbs syndrome which is a disorder of the nervous system also called Willis-Ekbom disease or when the subject is suffering from nocturnal myoclonus, which causes involuntary and periodic movements of the limbs during sleep or when the subject suffers from insomnia or somnambulism. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the sensor of the muscular electrical activity of the legs, and the signal processing means is also configured to detect among the signals measured by the muscle electrical activity sensor signals correlated to predefined movements; especially sudden or jerky movements. This detection can be carried out by an amplitude demodulation technique known to those skilled in the art. In one embodiment, the measurement can be performed by at least one electrode located at the level of a calf when the pants are worn by the subject.

According to one embodiment, the pants of the set also include a motion and body positioning sensor. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the body movement and positioning sensor.

According to one embodiment, the sensor movement of the set, integrated either in the cap, in the undershirt and / or in the pants, is an accelerometer. According to one embodiment, the signal processing means is configured to know the position of the subject during sleep from the signals measured by the motion sensor, in particular to know whether the subject sleeps on the right or left side, on the back or stomach. According to one embodiment, the signal processing means is also configured to detect a physical effort from the signals measured by the movement sensor. According to one embodiment, the signal processing means is further configured to calculate the energy expenditure of the subject from the signals measured by the motion sensor. According to one embodiment, the signal processing means is configured to identify the movements of the subject from the signals measured by the movement sensor. These operations are carried out using a 3-axis (accelerometer), 6-axis (accelerometer and gyroscope) or 9-axis (accelerometer, gyroscope and magnetometer) acetimeter (IMU, “inertial motion unit”). According to one embodiment, these signals are then analyzed according to signal processing methods (filtering, integration, thresholding) and classification with respect to models or artificial intelligence software. This analysis is known to those skilled in the art, and results in a classification of the energy expenditure of the subject, knowing his mass, and an estimate of his physical effort.

According to one embodiment, each sensor is electrically connected to at least one conductive interconnection track included in the cap, undershirt and/or pants, said conductive interconnection track being configured to allow the connection between at least one sensors and at least one of the other components of an electronic circuit included in the assembly.

According to one embodiment, each conductive interconnection track is produced by weaving, embroidery, lace, sewing or knitting conductive threads or by printing conductive ink. This embodiment makes it possible to advantageously eliminate any electric wire placed freely around the subject and which could hinder his movements.

According to one embodiment, the undershirt of the set comprises a first mechanical and electrical connection element and the pants of the set comprise at least one second mechanical and electrical connection element configured to be mechanically and electrically connected with a first mechanical and electrical connection element and at least one conductive interconnection track configured to electrically connect to at least one sensor or an electronic system. Advantageously, the integration of the sensors, the wiring and the electronic system in the clothing allows the subject to put on and take off the assembly during long measurement sessions (that is to say 24 hours or even 48 hours ).

According to one embodiment of the present invention, the first mechanical and electrical connection element on the undershirt of the assembly is a female element intended to cooperate with a male element of the second mechanical and electrical connection element of the pants of the assembly. 'together.

According to an alternative embodiment, the first mechanical and electrical connection element on the undershirt of the set is a male element intended to cooperate with the female element of the second mechanical and electrical connection element on the pants of the together.

According to one embodiment, the first mechanical and electrical connection element on the undershirt of the set and a second mechanical and electrical connection element on the pants of the set are a male snap button and a female snap button or Conversely.

According to one embodiment, the assembly further comprises means for transmitting the electrical signals acquired by the acquisition means to a signal processing means.

According to one embodiment, the assembly further comprises signal processing means.

According to one embodiment, the signal processing means is configured to detect, among the signals measured by the cerebral electrical activity sensor, electro-oculogram, and/or electromyogram, the different phases of the sleep cycle.

According to one embodiment, the signal processing means is also configured to detect, among the signals measured by the sensor of electrical activity of the heart muscle, the heartbeats or the variations in rhythm of the heartbeats. This detection uses an algorithm for detecting QRS peaks known to those skilled in the art, among which may be mentioned by way of example the El-Gendi algorithm or the Pan-Thompkins algorithm. According to one embodiment, the signal processing means is also configured to identify abnormalities due to cardiac activity in the signals of cerebral electrical activity. This detection uses a decomposition into independent components and principal components (ICA and PCA) or correlation analyzes known to those skilled in the art.

In one embodiment, the assembly comprises a plurality of acquisition means, transmission means and signal processing means.

In one embodiment, the signal processing means is remote from the assembly and is connected by wire. In one embodiment, the signal processing means is remote from the assembly and is connected wirelessly, in particular by means of information transmission means of the Bluetooth or wi-fi type.

According to one embodiment, the signal processing means comprises a memory unit, said memory unit comprising physiological markers, in particular linked to the various sleep disorders; and the signal processing means is configured to identify physiological activities characteristic of certain sleep disorders from among the signals measured by the cardiac muscle electrical activity sensor, the cerebral electrical activity, the electrical activity of the masticatory muscles, electrical activity of submental muscles, eye movement, respiratory movements of abdomen and thorax, air pressure during inhalation and exhalation through the nostrils, air movement through the mouth during inhalation and exhalation, snoring sounds from the rib cage and mouth, electrical activity of arm and leg muscles, blood oxygen concentration and/or body temperature, posture, movements acquired by the IMU. This identification uses an activity recognition algorithm specific to sleep disorders based on network analysis using artificial intelligence such as neural networks.

In one embodiment, the assembly comprises an electronic device allowing real-time storage of electrical signals acquired by the acquisition means in order to then transmit them in packets to the signal processing means through the transmission means.

According to one embodiment, the assembly according to the invention also comprises at least one remote storage means and means of communication to said at least one remote storage means of the cloud computing or remote server type.

According to one embodiment, the signal processing means is configured to identify or annotate the side effects of a medical treatment via an electronic collection of information. This collection can be direct (entry of the subject's data on a software application) or indirect (collection via a third-party computer system). In particular, side effects that result in changes in heart muscle electrical activity, brain electrical activity, masticatory muscle electrical activity, submental muscle electrical activity, eye movement, respiratory thorax and abdomen, air pressure during inhalation and exhalation through the nostrils, air movement through the mouth during inhalation and exhalation, breath sounds from the rib cage and mouth, electrical activity of arm and leg muscles, blood oxygen concentration and/or body temperature, position, movements acquired by the IMU.

According to one embodiment, the assembly also comprises either in the cap, in the undershirt and/or in the trousers a location suitable for receiving an electronic system comprising the acquisition means, the means for transmitting electrical signals and optionally the signal processing means. According to one embodiment, the assembly also comprises either in the cap, in the undershirt and/or in the pants a location capable of receiving a battery allowing the electrical supply of the electronic system. Said battery can be removably connected to the hat, the undershirt, the pants and/or the electronic module to allow recharging between two uses of the undershirt.

The present invention further relates to a cap for an ensemble as described above.

Said cap comprises at least one cerebral electrical activity sensor, one eye movement sensor and one electrical activity sensor of the masticatory and submental muscles.

In one embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the cerebral electrical activity sensor, an eye movement sensor and a sensor of the electrical activity of the masticatory and submental muscles.

In one embodiment, the cap includes a plurality of conductive electrodes capable of measuring cerebral electrical activity. According to one embodiment, said conductive electrodes are conductive electrodes not requiring gel during implementation, preferably said conductive electrodes are dry conductive electrodes. According to one embodiment, the plurality of conductive electrodes capable of measuring cerebral electrical activity are conductive electrodes comprising a gel, in particular an ionic gel. According to one embodiment, the cerebral electrical activity sensor is a plurality of capacitive electrodes. According to an alternative embodiment, the electrodes comprise textile electrodes woven, knitted, embroidered, deposited or printed in, under or on said textile garments.

According to one embodiment, the plurality of conductive electrodes capable of measuring cerebral electrical activity are arranged according to the international 10/20 system. Alternatively, the plurality of conductive electrodes capable of measuring cerebral electrical activity can be arranged according to any other system, such as the 10/10 system or the 10/5 system.

According to one embodiment, the cap, able to be worn on the subject's head and at the level of the subject's masticatory muscles, comprises 21 conductive electrodes able to measure cerebral electrical activity; said conductive electrodes being preferably positioned according to the international 10/20 system.

According to one embodiment, the cerebral electrical activity sensor comprises at least six conductive electrodes and a reference electrode. In this embodiment, the six electrodes are arranged according to the international 10/20 or 10/10 system. The locations of the six electrodes were chosen between the locations of the international 10/20 or 10/10 system according to medical prescription as optimal for monitoring sleep stages.

According to an alternative embodiment, the cap comprises a plurality of housings capable of receiving a plurality of conductive electrodes capable of measuring cerebral electrical activity.

According to one embodiment, the cap suitable for being worn on the subject's head and at the level of the subject's masticatory muscles also comprises at least one reference electrode serving as a reference for the electrodes of the cap in order to measure an electrical potential difference. According to one embodiment, this at least one reference electrode is located on the cap so as to be positioned in contact with the skin in the middle of the subject's forehead. According to one embodiment, this at least one reference electrode is located on the cap so as to be positioned at the mastoid process of the subject when the cap is worn by the subject. According to an alternative embodiment, the reference electrode is placed in position FpZ according to the international 10/20 system.

According to one embodiment, said reference electrode does not require gel during implementation, preferably said at least one reference electrode is a dry conductive electrode. According to one embodiment, the reference electrode is a textile electrode. According to an alternative embodiment, said reference electrode is a conductive electrode comprising a gel, in particular an ionic gel

In view of the low intensity of the signals of cerebral electrical activity, the signals measured are often "polluted" by parasitic signals, and in particular, the electrical signals emitted by the masticatory muscles, due to their intensities and their proximity to the brain. It is therefore necessary to differentiate the signals of cerebral electrical activity from other parasitic signals in order to allow a reliable analysis of the signals of cerebral electrical activity.

According to one embodiment, the signal processing means is therefore also configured to detect, among the signals measured by the cerebral electrical activity sensor, the signals measured by the electrical activity sensor of the masticatory muscles. These signals can then be attenuated in the cerebral electrical signal or enhanced so that the interpreter clearly identifies them as such. This detection uses a decomposition into independent components and principal components (ICA and PCA) or correlation analyzes known to those skilled in the art.

According to one embodiment, the eye movement sensor uses at least two electrodes or an infrared light optical sensor. In the embodiment using the electrodes, the reference electrode of the cerebral electrical activity sensor is also used as a reference electrode for measuring the cerebral electrical activity.

According to one embodiment, the measurement can be performed by at least three conductive electrodes, comprising a pair of measurement electrodes and a reference electrode. In one embodiment, the electrode of the pair of electrodes allowing the measurement of the movement of the left eye is located on the cap so as to be positioned under the exterior angle of the subject's left eye when the garment The cap-type garment is worn by the subject and the correlated reference electrode is located on the cap so as to be positioned over the subject's left and/or right mastoid when the cap-type garment is worn by the subject. The electrode of the pair of electrodes allowing the measurement of the movement of the right eye is located on the cap so as to be positioned above the exterior angle of the subject's right eye when the cap is worn by the subject. The pairs of electrodes measure ocular activity thanks to the potential difference existing between the cornea and the retina of the eye. According to one embodiment, the pair of measurement electrodes is integrated into the fabric of the cap where the pair of electrodes consists of two gel electrodes attached to the cap by supports, in particular cables. According to one embodiment, the reference electrode is placed on the subject's left and/or right mastoid. Alternatively, the electrode in the FpZ position of the cerebral electrical activity sensor can be used as a reference for the eye movement sensor.

According to one embodiment, the electrodes comprise textile electrodes woven, knitted, embroidered, deposited or printed in, under or on said textile garments. According to one embodiment, the electrodes do not require gel during implementation, preferably said at least one reference electrode is a dry conductive electrode. According to an alternative embodiment, said electrodes are conductive electrodes comprising a gel, in particular an ionic gel.

The eye movement sensor makes it possible in particular to determine the moment in which the subject enters a stage of the sleep cycle, such as for example the stage of paradoxical sleep, which is characterized by rapid eye movements. This embodiment also makes it possible to identify the spurious signals due to eye movements among the signals measured by the cerebral electrical activity sensor. This embodiment also makes it possible to determine involuntary movements of the eyeballs, linked to certain sleep disorders.

In one embodiment, the signal processing means is also configured to detect, among the signals measured by the cerebral electrical activity sensor, the signals measured by the eye movement sensor. This detection uses a decomposition into independent components and principal components (ICA and PCA) or correlation analyzes known to those skilled in the art.

The electrical activity sensor of the masticatory and submental muscles makes it possible in particular to identify muscle atony, characterized by the reduction in tone and contractility of the masticatory and submental muscles, and is typical of the paradoxical phase of sleep. This embodiment also makes it possible to detect bruxism, characterized by an unconscious movement of the masticating apparatus, either by clenching or by lateral movements, then called teeth grinding.

According to one embodiment, the sensor of electrical activity of the masticatory muscles comprises two electrodes. According to one embodiment, the conductive electrode capable of measuring the electrical activity of the masticatory muscles is located on the cap so as to be positioned at the level of the mandible when the cap is worn by the subject. According to this embodiment, the cap comprises at least one textile portion capable of being positioned at the level of the masticatory muscles when the cap is worn by the subject.

According to one embodiment, the cap comprises at least two textile portions capable of being positioned at the level of the mandible on either side of the subject's head when the cap is worn by the subject. In one embodiment, the two conductive electrodes capable of measuring the electrical activity of the masticatory muscles are two textile electrodes, each being located in one of the two textile portions. In one embodiment, the two conductive electrodes capable of measuring the electrical activity of the masticatory muscles are two textile electrodes located in the same textile portion. According to one embodiment, said conductive electrodes are conductive electrodes not requiring gel during implementation, preferably said conductive electrodes are dry conductive electrodes.

In one embodiment, the cap comprises at least one conductive electrode capable of measuring the electrical activity of submental muscles.

According to one embodiment, the conductive electrode capable of measuring the electrical activity of the submental muscles is located on the cap so as to be positioned at the level of the chin when the cap is worn by the subject. According to this embodiment, the cap comprises at least one textile portion capable of being positioned at the level of the submental muscles when the cap type is worn by the subject. In this embodiment, the conductive electrode capable of measuring the electrical activity of submental muscles is a textile electrode located in said at least one textile portion. According to an alternative embodiment, said conductive electrodes are conductive electrodes not requiring gel during implementation, preferably said conductive electrodes are dry conductive electrodes.

According to one embodiment, the cap further comprises a strap for the chin in which is integrated a sensor of electrical activity of the muscles of the chin. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the sensor of electrical activity of the chin muscles.

According to one embodiment, the cap further comprises a sensor oxygen saturation in the blood. According to one embodiment, the blood oxygen concentration sensor is an optical sensor in contact with the skin. According to one embodiment, the blood oxygen concentration sensor is an oximeter located on the cap so as to be positioned in or on an ear or on the skin at the subject's neck or forehead when the cap is worn by the subject.

According to one embodiment, the cap also comprises a head movement and positioning sensor. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the head movement and positioning sensor.

According to one embodiment, the cap-type garment suitable for being worn on the subject's head and at the level of the masticatory muscles or submental muscles of the subject also comprises a movement and position sensor of the subject's head. According to one embodiment, the measurement can be performed by an accelerometer and/or actimeter.

According to one embodiment, the cap able to be worn on the head of the subject and at the level of the masticatory muscles of the subject also comprises a body temperature sensor of the subject.

According to one embodiment, the subject cap also includes an electromagnetic radiation sensor.

According to one embodiment, the cap comprises a location capable of receiving an electronic system comprising the acquisition means, the electrical signal transmission means and optionally the signal processing means. According to one embodiment, the cap also includes a location capable of receiving a battery allowing the electrical supply of the electronic system. Said battery can be removably connected to the cap or to the electronic module to allow recharging between two uses of the undershirt.

According to one embodiment, each sensor is electrically connected to at least one conductive interconnection track included in the cap, said conductive interconnection track being configured to allow connection between at least one of the sensors and at least one of the other components of an electronic circuit included in the cap.

According to one embodiment, each conductive interconnection track is produced by weaving, embroidery, lace, sewing or knitting conductive threads or by printing conductive ink. This embodiment makes it possible to advantageously eliminate any electric wire placed freely around the subject and which could hinder his movements.

The present invention comprises, among other things, an undershirt for the assembly as described above comprising an electrical activity sensor of the heart muscle, a respiration sensor at the level of the thorax and at the level of the belly, a flow sensor of air leaving and entering through the nostrils and a motion and position sensor of the subject's chest.

According to one embodiment, the undershirt comprises a plurality of conductive electrodes capable of measuring the electrical activity of the cardiac muscle. According to one embodiment, the undershirt comprises 2, 4, 6, 8, 12 or more conductive electrodes, preferably two, capable of measuring the electrical activity of the cardiac muscle. According to one embodiment, the sensor of the electrical activity of the cardiac muscle comprises a plurality of conductive electrodes that do not require gel during implementation. In one embodiment, the heart muscle electrical activity sensor includes a plurality of dry conductive electrodes. According to one embodiment, the cardiac muscle electrical activity sensor comprises a plurality of capacitive electrodes. According to one embodiment, the conductive electrodes comprise textile electrodes woven, knitted, embroidered, deposited or printed in, under or on said textile garments.

According to one embodiment, a plurality of conductive electrodes are located on the undershirt so as to be positioned at the level of the cardiac muscle when the undershirt is worn by the subject.

According to one embodiment, the undershirt also comprises at least one reference electrode serving as a reference for the electrodes of the undershirt in order to measure an electrical potential difference.

According to one embodiment, the breathing sensor at the level of the thorax and at the level of the stomach in the undershirt comprises at least one textile elastic band, woven, knitted or embroidered in the undershirt-type garment capable of measuring the respiratory activity of the subject. According to one embodiment, said textile elastic band comprises an inductive means making it possible to measure the distance between the rib cage, i.e. the change in diameter of the rib cage. According to one embodiment, the undershirt is able to be worn at the level of the rib cage and comprises a textile elastic band located on the undershirt so as to be positioned at the level of the rib cage when the undershirt is carried by the subject. According to a preferred embodiment, the undershirt is able to be worn on the bust of the subject and comprises a first textile elastic band located on the undershirt so as to be positioned at the level of the rib cage when the garment of the type undershirt is worn by the subject, and a second textile elastic band located on the undershirt so as to be positioned at the level of the navel when the undershirt is worn by the subject.

The sensor of breathing at the level of the thorax and at the level of the stomach makes it possible in particular to detect the interruption of the respiratory flow, or the opposition of phase between the movement of abdominal and thoracic breathing linked for example to paradoxical breathing. According to one embodiment, the signal processing means is also configured to monitor the respiratory rhythm and identify a sleep disorder called Cheyne-Stokes respiration, characterized by an abnormal periodic respiratory rhythm which presents a regular alternation of periods of apnea and hyperpnea (increased amplitude breathing).

According to one embodiment, the undershirt further comprises a blood oxygen saturation sensor (oximeter). This embodiment makes it possible in particular to detect the oxygenation of the blood, in fact oxygen desaturation is typical of sleep apnea. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the oxygenation of the blood. According to one embodiment, the blood oxygen concentration sensor is an optical sensor in contact with the skin. According to one embodiment, the blood oxygen concentration sensor is located on the undershirt so as to be positioned on the subject's torso when the undershirt is worn by the subject.

According to one embodiment, the measurement of the airflow through the nostrils is carried out by an exhaled air pressure sensor channeled in nasal cannulas.

According to one embodiment, the undershirt further comprises a sound sensor resulting from snoring coming from the subject's rib cage. This embodiment makes it possible in particular to record the sounds resulting from snoring through the rib cage. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the snoring sound sensor originating from the rib cage. The sound sensor may be a microphone also suitable for recording environmental noises and noise produced by the mouth of the subject. Such a sound sensor makes it possible in particular to detect catathrenia, which is a rapid eye movement sleep disorder consisting of inspiratory apnea (retention of breath) and an expiratory moan during sleep.

According to one embodiment, the undershirt further comprises an electrical activity sensor of the muscles of the arms. This embodiment makes it possible in particular to detect the muscular movements of the arms occurring, for example, when a subject is suffering from restless limbs syndrome which is a disorder of the nervous system also called Willis-Ekbom disease or when the subject is suffering from nocturnal myoclonus or REM sleep behavior disorder, which causes involuntary and periodic movements of the limbs during sleep or when the subject suffers from insomnia or sleepwalking. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the muscle electrical activity sensor of the arms, and the signal processing means is also configured to detect among the signals measured by the muscle electrical activity sensor signals correlated to predefined movements; especially sudden or jerky movements. This detection can be carried out by an amplitude demodulation technique known to those skilled in the art.

According to one embodiment, the undershirt suitable for being worn on the chest of the subject also comprises an electrical activity sensor of the muscles of the arms (deltoids) and back (trapezoids). In one embodiment, the measurement can be performed by at least one electrode located at the level of a forearm when the undershirt is worn by the subject.

According to one embodiment, said undershirt comprises a sensor flow of air entering and leaving through the mouth. This embodiment makes it possible in particular to monitor the respiratory rate and detect sleep hypopnea, characterized by a 30% reduction in the respiratory flow, or sleep apnea, characterized by the interruption of the respiratory flow. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the sensor of the flow of air entering and leaving through the mouth.

According to one embodiment, the undershirt suitable for being worn on the subject's chest also comprises a motion and position sensor of the subject's body. According to one embodiment, the measurement can be performed by an accelerometer and/or actimeter. Advantageously, the information concerning the position of the bust, combined with the information concerning the position of the head, makes it possible to know the exact position of the subject's body which can impact the quality of breathing during sleep.

According to one embodiment, the undershirt also includes a subject's body temperature sensor.

According to one embodiment, the undershirt also comprises a location capable of receiving an electronic system comprising the acquisition means, the electrical signal transmission means and optionally the signal processing means. According to one embodiment, the undershirt also comprises a location capable of receiving a battery allowing the electrical supply of the electronic system. Said battery can be removably connected to the undershirt or to the electronic module to allow recharging between two uses of the undershirt.

According to one embodiment, each sensor is electrically connected to at least one conductive interconnection track included in the undershirt, said conductive interconnection track being configured to allow the connection between at least one of the sensors and at least one of the other components of an electronic circuit included in the undershirt.

According to one embodiment, each conductive interconnection track is produced by weaving, embroidery, lace, sewing or knitting conductive threads or by printing conductive ink. This embodiment makes it possible to advantageously eliminate any electric wire placed freely around the subject and which could hinder his movements.

According to one embodiment, the undershirt comprises a first mechanical and electrical connection element configured to be mechanically and electrically connected with a second mechanical and electrical connection element and at least one conductive interconnection track configured to electrically connect to at least one least one sensor or electronic system.

According to one embodiment, each conductive interconnection track is produced by weaving, embroidery, lace, sewing or knitting conductive threads or by printing conductive ink. This embodiment makes it possible to advantageously eliminate any electric wire placed freely around the subject and which could hinder his movements.

According to one embodiment of the present invention, the first mechanical and electrical connection element on the undershirt of the assembly is a female element intended to cooperate with a male element of the second mechanical and electrical connection element. According to an alternative embodiment, the first mechanical and electrical connection element on the undershirt of the assembly is a male element intended to cooperate with the female element of the second mechanical and electrical connection element.

According to one embodiment, the first mechanical and electrical connection element on the undershirt is a male snap button or a female snap button.

According to one embodiment, the pants further comprise a sensor of electrical activity of the leg muscles. This embodiment makes it possible in particular to detect the muscular movements of the legs occurring, for example, when a subject is suffering from restless limbs syndrome which is a disorder of the nervous system also called Willis-Ekbom disease or when the subject is suffering from nocturnal myoclonus, which causes involuntary and periodic movements of the limbs during sleep or when the subject suffers from insomnia or somnambulism. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the sensor of the muscular electrical activity of the legs, and the signal processing means is also configured to detect among the signals measured by the muscle electrical activity sensor signals correlated to predefined movements; especially sudden or jerky movements. This detection can be carried out by an amplitude demodulation technique known to those skilled in the art. In one embodiment, the measurement can be performed by at least one electrode located at the level of a calf when the pants are worn by the subject.

According to one embodiment, the pants also include a body movement and positioning sensor. In this embodiment, the acquisition means is also configured to acquire in a synchronized manner the signals measured by the body movement and positioning sensor.

According to one embodiment, the sensor integrated either in the hat, in the undershirt and / or in the pants is an accelerometer. According to one embodiment, the signal processing means is configured to detect a physical effort from the signals measured by the motion sensor. According to one embodiment, the signal processing means is configured to calculate the energy expenditure of the subject from the signals measured by the motion sensor. According to one embodiment, the signal processing means is configured to identify the movements of the subject from the signals measured by the movement sensor. These operations are carried out using a 3-axis (accelerometer), 6-axis (accelerometer and gyroscope) or 9-axis (accelerometer, gyroscope and magnetometer) acetimeter (IMU, “inertial motion unit”). According to one embodiment, these signals are then analyzed according to signal processing methods (filtering, integration, thresholding) and classification with respect to models or artificial intelligence software. This analysis is known to those skilled in the art, and results in a classification of the energy expenditure of the subject, knowing his mass, and an estimate of his physical effort.

According to one embodiment, the pants also include a location capable of receiving an electronic system comprising the acquisition means, the electrical signal transmission means and optionally the signal processing means. According to one embodiment, the pants also include a location suitable for receiving a battery allowing the electrical supply of the electronic system. Said battery can be removably connected to the pants or to the electronic module to allow recharging between two uses of the undershirt.

According to one embodiment, each sensor is electrically connected to at least one conductive interconnection track included in the pants, said conductive interconnection track being configured to allow connection between the sensors and at least one of the other components of a electronic circuit included in the pants.

According to one embodiment, the pants comprise a first mechanical and electrical connection element configured to be mechanically and electrically connected with a second mechanical and electrical connection element and at least one conductive interconnection track configured to electrically connect to at least one sensor or electronic system.

According to one embodiment of the present invention, the first mechanical and electrical connection element on the pants of the assembly is a female element intended to cooperate with a male element of the second mechanical and electrical connection element. According to an alternative embodiment, the first mechanical and electrical connection element on the pants of the set is a male element intended to cooperate with the female element of the second mechanical and electrical connection element.

According to one embodiment, the first mechanical and electrical connection element on the pants is a male press stud or a female press stud.

Figure 1 is a schematic representation of the set 1 comprising a cap 2, an undershirt 3 and the pants 4 according to a first embodiment of the invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

As illustrated in Figure 1, the set 1, according to a first embodiment comprises a cap 2 and an undershirt 3.

Cup 2 includes a brain electrical activity sensor 21 arranged according to the international 10/20 system.

The cap 2, according to a first embodiment, comprises two electrodes allowing the measurement of the movement of the eye 22, one on the right side and one on the left side.

Cup 2 also includes a chin strap in which the conductive electrode is integrated at chin level to measure the electrical activity of submental muscles 23.

According to this first embodiment, the cup 2 comprises an accelerometer 25 and at the level of the forehead an oximeter 24.

According to this first embodiment illustrated in Figure 1, the undershirt 3 comprises an electrical activity sensor of the heart muscle 31 positioned at the level of the heart muscle when the undershirt is worn by the subject.

The undershirt 3 further comprises a first textile elastic band 32 located on the undershirt so as to be positioned at the level of the rib cage when the undershirt-type garment is worn by the subject, and a second elastic band textile 32 located on the undershirt so as to be positioned at the level of the navel when the undershirt is worn by the subject.

The undershirt 3 comprises a nasal cannula 33 which channels the exhaled air towards a pressure sensor to measure the airflow of the nostrils and a microphone placed at the level of the rib cage as a sensor of sounds resulting from snoring coming from of the rib cage of subject 35.

According to this first illustrated embodiment, the undershirt 3 further comprises an accelerometer and/or actimeter 34 positioned at the level of the bust when the undershirt is worn by the subject for measuring the movement and the position of the bust of the subject.

In Figure 1, the undershirt 3 further comprises a location capable of receiving a battery 36 positioned at chest level when the undershirt is worn by the subject and a location capable of receiving an electronic system.

Figure 1 further illustrates the pants 4 comprising an electrode 41 located at the level of a calf when the pants are worn by the subject.

The present invention is not limited to the illustrated embodiments but extends to all other possible embodiments known to those skilled in the art. The illustrations are not to scale and the dimensions measured in the various figures should not be used to interpret or limit the present invention.

Claims (14)

Set for monitoring the physiological signals of a subject (1) for the diagnosis or monitoring of sleep disorders comprising:

• a cap (2) adapted to be worn on the head of the subject, comprising: a cerebral electrical activity sensor (21), an eye movement sensor (22) and an electrical activity sensor of the masticatory and submental muscles (23 );
• an undershirt (3) adapted to be worn on the chest of the subject, comprising a sensor of electrical activity of the heart muscle (31), a respiration sensor at the level of the thorax and at the level of the stomach (32), a sensor air flow through the nostrils (33) and a sensor of movement and position of the subject's chest (34), and a sensor of sounds resulting from snoring (35);
• a sensor of the electrical activity of the leg muscles (41).
  

An assembly according to claim 1, further comprising a blood oxygen saturation sensor.
An assembly according to claim 1 or claim 2, further comprising acquisition means configured to synchronously acquire the signals measured by said measuring means.
Assembly according to claim 3, further comprising means for transmitting the electrical signals acquired by the acquisition means to a signal processing means.
An assembly according to any one of claims 1 to 4, further comprising trousers (4) suitable for being worn over the legs of the subject and in which the sensor of the electrical activity of the muscles of the legs (41) is included.
Assembly according to claim 5, in which the undershirt (3) comprises a first mechanical and electrical connection element and the pants (4) comprises at least a second mechanical and electrical connection element configured to be mechanically and electrically connected with a first mechanical and electrical connection element.
Cap (2) for an assembly (1) according to any one of claims 1 to 6, including:

• a cerebral electrical activity sensor (21);
• an eye movement sensor (22);
• a sensor of electrical activity of the masticatory and submental muscles (23).
  

A cap according to claim 7, wherein the cerebral electrical activity sensor comprises at least six electrodes.
A cap according to claim 7 or claim 8, wherein the eye movement sensor comprises at least two electrodes or an infrared light optical sensor.
A cap according to any of claims 7 to 9, further comprising a blood oxygen saturation sensor positionable in contact with the subject's forehead (24).
Undershirt (3) for a set (1) according to any one of claims 1 to 6 comprising:

• a heart muscle electrical activity sensor (31);
• a respiration sensor at the level of the thorax and at the level of the belly (32);
• a nostril airflow sensor (33);
• a motion and position sensor of the subject's chest (34);
• a sensor of sounds resulting from snoring coming from the rib cage of the subject (35).
  

An undershirt according to claim 11, further comprising a blood oxygen saturation sensor.
An undershirt according to claim 11 or claim 12, further comprising an airflow sensor generated by the subject's mouth.
Trousers (4) for an assembly (1) according to any one of claims 1 to 6 comprising an electrical activity sensor of the leg muscles (41).