RU2553185C1 - Device for correction of sleep characteristics - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: device for correction of sleep characteristics contains sensor for registration of electrodermal activity EDA, connected with unit of analysis and extraction of signals of skin-galvanic responses SGR, generator of stimulating electric pulses, on-skin electrodes and control unit. Device is made in form of monoblock with possibility of fastening on user's palm. Monoblocks case has front and back side, and fastening elements. Three electrodes, placed with possibility of galvanic connection with skin of user's hand palm, are located on back part. Measuring electrode is connected to input of sensor for EDA registration, with stimulating electrode being connected to output of generator of electric pulses, with the third one being common neutral electrode of galvanic circuits of said sensor and generator. Units of analysis and extraction of SGR signals and control unit are made on base of microprocessor with possibility of periodical control of current condition of galvanic contact of electrodes with skin, cyclic measuring of SGR intensity and supply of stimulating electric pulses in pauses between SGR measuring, and provide three modes of functionality: sleeping mode - in absence of galvanic contact of electrodes with skin; mode of EDA registration - in presence of galvanic contact of electrodes with skin, including extraction of SGR pulses and counting their quantity N for given time interval and comparison with threshold value; mode of stimulation - if quantity N of SGR pulses exceeds threshold value, including periodical supply of electric pulses to stimulating electrodes during specified time interval.EFFECT: invention application makes it possible to extend arsenal of technical means for correction of patient's physical condition during sleep and further wakefulness, increase index of slow-wave sleep stage, power of delta-waves and therefore deepen sleep sensation, phases of fast eye motions, and increase sleep quality in general.9 cl, 10 dwg

Description

The invention relates to medical equipment and can be used in clinical conditions and at home for the treatment of sleep disorders, neurosis, depressive states and psycho-emotional disorders.

The problem of sleep disorders and depressive states is extremely relevant in connection with the widespread occurrence of these diseases in recent years. Many methods of treating these disorders have been described, including physical methods that allow one to some extent to correct the structure of sleep and depressive states. Studies have found that the visceral systems of the body in the slow wave phase are associated with the activity of delta waves in the phase of slow wave sleep (Pigarev I.N. “Visceral sleep theory”, ZhVND, 2013, v. 63, No. 1, pp. 86-104). In turn, sleep disorders and sleep of patients with depression is due to a low index of slow-wave sleep. It was shown that low-frequency electrical stimulation increases the duration of the stages of slow-wave sleep in the first half of the night and helps to increase the power of delta waves in these stages, which generally contributes to the normalization of sleep (Indursky P.A., Markelov V.V., Shakhnarovich V.M. , Dorokhov VB “Low-frequency electrodermal stimulation of the hand during the slow-wave stage of night sleep: Physiological and therapeutic effects. Human Physiology, 2013, v. 39, No. 6, pp. 91-105).

A method for stimulating the human body in the slow-wave stage of sleep is described (RU 2304988 C2, Dunaevsky, Indursky, 08.27.2007). A low-amplitude electrical and / or magnetic stimulation is performed that does not awaken the patient. In this case, the stimulation is carried out during the slow wave stages of night sleep at a frequency in the range of 0.5 ÷ 4 Hz, which is as close as possible to the characteristic frequency of the delta activity of the patient’s brain. The duration of the continuous cycle of stimulation is at least 10 minutes with a repeat in all the slow-wave stages of sleep during the night. The total duration of the primary course is at least 10 consecutive nights. With positive dynamics, the treatment course is continued, but in the absence of dynamics, they switch to a different type of stimulation: from electric to magnetic, and vice versa, or to combined stimulation, in which electric and magnetic stimuli are successively used for one night or two subsequent nights. However, this method does not provide for the use of autonomous hardware and does not disclose means for automatically tracking the onset and end of the slow-wave sleep stage.

Various electrostimulating devices for treating insomnia and other disorders are described. So, in the device RU 112630 U1, Altukhov et al., January 20, 2012 ) a device is described in which a programmable microprocessor determines the conditions for generating pulses from the generator to the output signal amplifier, which sets the current pulses to the electrostimulator electrodes. The impact on theta and delta rhythms of the brain decreases the activity of brain structures, which leads to analgesia, the removal of fears and various cramps, antidepressant effects, provides relaxation and peace. The disadvantage of this solution is the lack of feedback.

A device for relieving psychophysiological stresses (RU 00095 U1, Feoktistov et al., 10.25.1994) contains a control unit in series, a control signal generation unit in the form of a single-chip computer, a decoder, an exposure signal generation unit and a polymodal block for sensory organs, sensors of respiration and skin-galvanic reaction. However, in this device, the sensors are designed to generate noise signals and exercise the will and does not provide sleep stimulation.

The patent (CN 202892665 (U), HUANG HAIHUA et al., 04.24.2013) describes a microprocessor-based device for treating sleep disorders, in which there is an electrostimulator controlled by signals from electrodes placed on the patient’s head and chest, monitoring the variability of cardiac activity while electrical stimulation is carried out through acupuncture points, which alleviates the symptoms of insomnia. However, the device does not track the individual dynamics of sleep patterns. In another invention (CN 103055417 (A), LIU GANG et al., 04.24.2013), a therapeutic apparatus with many functions includes a real-time respiratory health monitoring module, an electrical stimulation signal generation module, and non-implantable transdermal electrodes. However, the breath monitoring used in the invention does not reliably reflect the structure of sleep in respiratory disorders and the level of sleep saturation with delta waves.

CN 202020792 (U), DINGWAN MEDICAL TECHNOLOGY SUZHOU CO LTD, 02.11.2011 describes a device for electrical stimulation of the nervous system with an external sleep detection device including a pulse generator and an electrode that is connected to a pulse generator. The system also includes an external sleep detection device, which is used to evaluate whether the patient is in a deep sleep state. However, the principle of detecting a deep sleep state is not disclosed in this invention.

Closest to the patented invention is a device for tracking the appearance and end of the slow wave stage of sleep based on registration of electrodermal activity (EDA) and electrical stimulation (RU 2431508 C1, NEUROKOM, November 20, 2011 - prototype). The number N of electrical impulses of the skin-galvanic reaction (RAG) is determined and sleep states are classified. As an electrical stimulus, rectangular pulses with a filling frequency of 1-2 kHz, an amplitude of 50 to 500 μA and a current density of not more than 500 μA / cm ² are fed. The device includes the following elements: electrodes attached to the patient’s body for recording EDA, connected to an EDA reception unit; EDA analysis and RAG signal extraction unit; analysis unit of the patient’s current sleep with identification of the current state of sleep; a control unit connected to a stimulus generator, in the described case, to a rectangular electric pulse generator with a filling frequency of 1-2 kHz with adjustable amplitude, duration, pulse repetition rate, the output of which is connected to the electrodes for application of the stimulus. However, this decision is presented in the form of a principle and does not disclose a specific implementation, and, in addition, does not provide means for automatically regulating electrical stimulation.

The present invention is directed to the development of an autonomous wearable device to achieve effective sleep and more productive use of sleep time.

The patented device for correcting sleep characteristics contains a sensor for detecting EDA associated with RAG signal analysis and extraction blocks, a stimulating electric pulse generator, cutaneous electrodes, and a control module.

The difference of the invention lies in the fact that the device is made in the form of a monoblock with the possibility of fixing on the palm of the user's hand, the casing of which has front and back sides and fastening elements.

On the back of the case there are three electrodes mounted with the possibility of galvanic connection with the skin of the palm of the user's hand, one of which, the measuring one, is connected to the input of the sensor for recording EDA, the other is stimulating, to the output of the electric pulse generator, and the third is common the neutral electrode of the galvanic circuits of said sensor and generator.

The RAG signal analysis and isolation blocks and the control module are made on the basis of a microprocessor with the possibility of periodically monitoring the current state of the galvanic contact of the electrodes with the skin, cyclically measuring the RGR intensity and supplying stimulating electric pulses in the pauses between the RGR measurements and provide three operating modes:

- sleep mode in the absence of galvanic contact of the electrodes with the skin;

- EDA registration mode in the presence of galvanic contact of the electrodes with the skin, including the allocation of RHC pulses and counting their number N for a given time interval and comparing with a threshold value;

- stimulation mode when the number of N pulses of the RAG exceeds a threshold value, including the periodic supply of electrical pulses to the stimulating electrodes for a predetermined time interval.

The device can be characterized in that the current state of the galvanic contact of the electrodes with the skin is monitored by measuring the electrical resistance between the measuring and neutral electrodes, and also that the current state of the galvanic contact of the electrodes with the skin is carried out by applying voltage between the stimulating and neutral electrodes, and current measurements.

The device can be characterized by the fact that the galvanic contact of the electrodes with the skin in sleep mode is determined by periodically measuring the electrical resistance R between the measuring and neutral electrodes and comparing it with a threshold value.

The device can also be characterized by the fact that the extraction of RHC pulses and counting their number N is carried out for a time interval equal to the previous 60 s, and when N is equal to 6, electrical pulses are supplied to the stimulating electrodes for a time interval of 30 s.

The device can also be characterized by the fact that the electric pulse generator is configured to supply current pulses of 5-15 ms duration to the stimulating electrodes, a pulse repetition period of 0.5-1.5 s and a magnitude of at least 30 μA.

The device can be characterized, in addition, by the fact that the microprocessor is configured to store in the internal memory the parameters of the RAG, the integral characteristics of the pulses of the RGR and stimulating electrical pulses and select the level of stimulation for use in subsequent nights.

The device can be characterized, in addition, by the fact that it contains a wireless data transmission module for their subsequent analysis, as well as the fact that the battery compartment cover is made on the front side of the case.

The technical result is the expansion of the arsenal of technical means for correcting the physical condition of the patient during sleep and with further wakefulness, an increase in the index of the stage of slow-wave sleep, the power of delta waves, thereby deepening the feeling of sleep, the phase of rapid eye movements, and improving sleep quality in general.

The patented device implements the automatic inclusion of non-awakening non-invasive low-frequency pulsed stimulation at a certain moment - the highest intensity of RAG. Turning off the pulse stimulation is performed at a point in time when the intensity of the RAG decreases to a predetermined level. Electrical stimulation is switched on with pauses, and the RAG intensity is also measured in the pauses between stimulations.

The invention is illustrated in the drawings, where:

FIG. 1 - shows a block diagram of a device;

FIG. 2 - placement of the device on the arm;

FIG. 3 - device design, view of the electrodes from the back;

FIG. 4 is the same as in FIG. 3, side view;

FIG. 5 is the same as in FIG. 3, front view;

FIG. 6 is a state diagram of a microprocessor (MP) during operation;

FIG. 7 - algorithm for the operation of the MP in sleep mode;

FIG. 8 - the algorithm of the MP in the measurement mode;

FIG. 9 - algorithm for the operation of the MP in the measurement mode in pauses;

FIG. 10 - algorithm of the MP in the stimulation mode.

A block diagram of the device is shown in FIG. 1. The device contains MP 1, which can be performed, for example, on the basis of Atmel ATMega88PA-MU microcircuit and EDA sensor 2. The device contains a power element 3 (battery), two LEDs 4 for indicating operating modes and the charge level of element 3. The electric pulse generation unit 5 for controlling the current strength, duration and period of generation is connected to microprocessor 1.

In FIG. 2 shows the placement of the device in the palm of your hand, and in FIG. 3-5 - device design. The housing 20 of the device has a back and front sides.

Three electrodes 21, 22, 23 are placed on the back side, providing galvanic connection with the skin of the palm of the user's hand. Electrode 21 is neutral, electrode 22 is measuring, electrode 23 is stimulating. The housing 20 is connected with elements 24 for securing the device in the palm of your hand, for example with a tape or strap. On the front surface there is a cover 25 of the battery compartment, as well as an indicator 26 based on LEDs 4.

The device operates in sleep mode, measurement mode and measurement mode in pauses, stimulation mode, the relationship between which is shown schematically in FIG. 6, and operation algorithms are presented in FIG. 7-10.

MP 1 measures the electrical resistance R between the measuring 22 and neutral 21 electrodes; analysis of the values of resistance R and detection of pulses of RGR. Based on the analysis of the time sequence of RAG pulses, a decision is made on the beginning, continuation, or termination of stimulation.

Further, in accordance with the laid down algorithms, MP 1 generates control commands for the unit 5 for generating electric current pulses of a given frequency and duration applied between the neutral 21 and stimulating 23 electrodes. In addition, MP 1 monitors the voltage of the battery and controls the indication of various operating modes and charge level of the element 3.

In sleep mode (see Fig. 7), a device with a period of Tson = 3 s measures the resistance R. In the intervals between measurements, MP 1 is in a state of reduced power consumption. For each measured value of R, it is compared with a threshold value of Rpor = 3 MΩ.

At values R> Rpore, the device continues to work in sleep mode. The value of R≤Rpore corresponds to the normal contact of the electrodes 21, 22 with the skin. In this case, an additional check of the electrical contact of the stimulating electrode 23 with the skin is carried out: voltage is applied to the stimulating electrode and the current 1 is measured. If the value 1 turns out to be close to 0, it is concluded that the electrode 23 is not in good contact with the skin and the device remains in sleep mode . Otherwise, a conclusion is drawn about the normal contact of all three electrodes with the skin, the device is switched to measurement mode, and the signal LED lights up for 4 seconds.

In the measurement mode (see Fig. 8), the resistance R is measured periodically with a frequency of F = 8.3 Hz. After each measurement of R, the results are processed in order to detect RGR pulses. At the same time, the number N of detected RAG pulses is counted for the last Tism = 60 s. At the moment when the number N = 6, the device goes into stimulation mode. In stimulation mode, LED 4 pulsates - lights up every 4 s, for 10 ms.

In each measurement, the value of R is compared with a threshold value of Rpo = 3 MΩ. If the values of R> Rpor are fixed in a row for a given time interval Tout = 30 s, then it is concluded that the device is removed from the hand (or the contact of the measuring and neutral electrodes with the skin is bad, which is also interpreted as “the device is removed from the hand”) . In the latter case, the device goes into sleep mode.

In the stimulation mode (see Fig. 9), MP 1 periodically generates a potential difference between the neutral 21 and the stimulating 23 electrodes, which is necessary for the flow of a stimulating current pulse of a given value - 100 μA. Pulse duration Timp = 10 ms; pulse repetition period - Tper = 1.0 s. In stimulation mode, signal LED 4 lights up once every 1 second for 22 ms.

The duration of the stimulation mode is Tstim = 30 s, after which the device switches to the measurement mode in pauses.

In the measurement mode in pauses (see Fig. 10), the resistance R is measured periodically with a frequency of G = 8.3 Hz, the RHC pulses are searched, and their number is counted. The duration of the measurement mode in pauses leaves Tpauz = 30 s. At the end of the operation of the measurement mode in pauses, the number of N pulses of the RAG is compared with the threshold value of Npause = 3. If N≥N pause, then the device goes into stimulation mode. If the number N <N pauses, the device goes into measurement mode.

In the pause stimulation mode, the signal LED lights up once every 4 s for 10 ms.

A device for correcting sleep characteristics is used as follows. The device is attached to the palm of the patient shown in FIG. 2 way, so that all three electrodes are adjacent to the palm of your hand, and then the device operates autonomously and automatically. The EDA is measured, the RHC pulses are emitted, when the RHR intensity reaches a predetermined level, non-exciting pulsed stimulation is activated with a set duration of 1 Hz and a pulse current of not more than 500 μA. In a subsequent pause, the EDA is measured again. When the RAG intensity in the pause is equal to or greater than the recommended value, stimulation with the set duration is again turned on, if the RGR value is less than the set, then the measurement continues. The stimulation performs a subthreshold non-stimulating electrical stimulation of the palm receptors, which supposedly reaches the upper regions of the brain stem and the reticular formation rhythmically activating the delta wave of a sleeping patient. The value of the differential component of the skin resistance can be used to optimize the stimulation parameters within the acceptable current and pulse frequency values.

For a specialist it is obvious that the described modes of operation of the device are given only as an example and can change when using other chips and accessories.

Thus, a device that operates in automatic mode provides an expansion of the arsenal of technical tools that can be used to correct the patient’s physical condition during sleep and with further wakefulness, increase the index of the stage of slow-wave sleep, the power of delta waves and thereby deepen the feeling of sleep, improve its quality in general. The specified technical result is confirmed by testing a device for correcting sleep characteristics in patients.

Claims (9)

1. A device for correcting sleep characteristics, containing a sensor for recording electrodermal activity (EDA), associated with blocks of analysis and separation of signals of the skin-galvanic reaction (RAG), a generator of stimulating electrical pulses, cutaneous electrodes, a control module,
characterized in that
the device is made in the form of a monoblock with the possibility of fixing on the palm of the user's hand, the casing of which has front and back sides and fastening elements,
on the back of the case there are three electrodes mounted with the possibility of galvanic connection with the skin of the palm of the user's hand, one of which is the measuring one, is connected to the input of the sensor for recording EDA, the other is stimulating, to the output of the electric pulse generator, and the third is common the neutral electrode of the galvanic circuits of said sensor and generator,
RAG signal analysis and isolation blocks and a control module are made on the basis of a microprocessor with the ability to periodically monitor the current state of the galvanic contact of the electrodes with the skin, cyclically measure the RGR intensity and supply stimulating electrical pulses in the pauses between the RGR measurements and provide three modes of operation:
sleep mode - in the absence of galvanic contact of the electrodes with the skin;
EDA registration mode - in the presence of galvanic contact of the electrodes with the skin, including the allocation of RHC pulses and counting their number N for a given time interval and comparing with a threshold value;
stimulation mode - when the number of N pulses of the RAG exceeds a threshold value, including the periodic supply of electrical pulses to the stimulating electrodes for a predetermined time interval. 2. The device according to claim 1, characterized in that the current state of the galvanic contact of the electrodes with the skin is monitored by measuring the electrical resistance between the measuring and neutral electrodes. 3. The device according to claim 1, characterized in that the current state of the galvanic contact of the electrodes with the skin is controlled by applying voltage between the stimulating and neutral electrodes and measuring the current value. 4. The device according to claim 1, characterized in that the galvanic contact of the electrodes with the skin in sleep mode is determined by periodically measuring the electrical resistance between the measuring and neutral electrodes and comparing it with a threshold value. 5. The device according to p. 1, characterized in that the selection of the RAG pulses and counting their number N is carried out for a time interval equal to the previous 60 s, and when N is equal to 6, electrical pulses are supplied to the stimulating electrodes for a time interval of 30 s. 6. The device according to claim 1, characterized in that the electric pulse generator is configured to supply current pulses of 5-15 ms duration to the stimulating electrodes, a pulse repetition period of 0.5-1.5 s, and a magnitude of at least 30 μA. 7. The device according to p. 1, characterized in that the microprocessor is configured to store in the internal memory the parameters of the integral characteristics of the RAG pulses and stimulating electric pulses and to select a stimulation level for use on subsequent nights. 8. The device according to p. 1, characterized in that it contains a wireless data transmission module for their subsequent analysis. 9. The device according to p. 1, characterized in that on the front side of the housing there is a battery cover.

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