IT202000020833A1 - DEVICE AND METHOD FOR THE PREVENTION AND TREATMENT OF VESTIBULAR HEARING DISORDERS - Google Patents

Description

Title: Device and method for the prevention and treatment of vestibular hearing disorders

Description

field of technique

[001] The present invention relates to the use of a device for treating vestibular hearing disorders, both in the preventive phase and in the rehabilitative phase.

State of art

[002] Hearing problems such as deafness? are treated especially with mechanical applications cio? through hearing aids. Hearing rehabilitation passes through? also for the rehabilitation of the ability? listening cognition.

[003] And? been shown that an improved ability? listening leads to better hearing performance when testing words and sentences.

[004] Tinnitus ? also a listening hearing problem, intruding a sound in one's listening, both in listening moments when it should be null, and in moments when the person is listening to a sound source.

[005] In the field of hearing rehabilitation, the main inventions today are based on the use of new hearing devices that the patient must wear.

[006] Vision plays a key role in knowing our environment during every moment of our daily life. It ? essential for the coordination of all our movements in the space that surrounds us, for the precision with which we perform a task, with which we use a tool, to read or write and is? also fundamental in relationships and social communication with other human beings. AND? known that the stabilization of an image on the retina depends on the activity? of the vestibular and visual systems. The activity of gaze and posture stabilization? related to? activity? of listening being mainly governed by an organ which is in direct connection with the auditory organ. For example, the directionality of sound from new research appears to be governed by the vestibular system. Gaze stabilization and understanding are therefore directly linked to listening and understanding a speech itself.

[007] When the head rotates rapidly in the horizontal or anterior or posterior planes, the two semicircular canals of each pair participate in the estimation of how much ? fast head movement. The channel ipsilateral to the rotation provides the main excitatory information - through the vestibular nerve fibers - to which more information is added. weak and inhibiting from the contralateral channel. In response, the oculomotor system will induce an eye movement equal in amplitude but in an opposite direction to the movement of the head. This reflex, called the vestibulo-ocular reflex (VOR for short), enables image stabilization on the retina during rapid head movements and is estimated by a test known as the Functional Impulse Test (fHIT) (Halmagyi, G.M., and Curthoys, I.S. (1988). A clinical sign of canal paresis. Arch.Neurol.45, 737?739).

[008] The VOR ? centrally controlled (Leigh, R.G., Zee, D.S. (2015). The Neurology of Eye Movements, 5th edition. Universit Press, Oxford) and in particular the cerebellum has a fundamental role in the monitoring and adaptation of continuous visual gaze. For example, combining lesion and physiological studies, cerebellar regions closely related to ocular motor functions (VOR, pursuit and saccadic eye movements). Neurons in the vestibulocerebellum (i.e., a region of the cerebellum found in the flocculonodular lobe that receives vestibular and visual information) are fired in relation to head or target movement, during eye fixation and vestibular responses to head movement . Those located in the nodule and in the ventral uvula modulate the memorization mechanism of the speed? within the vestibular nuclei.

[009] Functional test pulse (fHIT) ? was developed to estimate VOR during passive head impulses. Halmagyi et Curthoys popularized the "head impulse test" in 1988, which allows identification of complete loss of peripheral vestibular function (see, as a general reference, Halmagyi GM, Curthoys IS. A clinical sign of canal paresis. Arch Neurol.1988;45:737-739).

[0010] The rotation of the head can achieve angular accelerations of thousands of degrees per second squared.

[0011] In other words, the VOR is tested by asking the subject to identify an optotype briefly presented during the passive or active head impulse (Corallo G, Versino M, Mandal? M, Colnaghi S, Ramat S. The functional head impulse test: preliminary data. J Neurol. 2018 Oct; 265 (Suppl 1):35-39. Versino M, Colnaghi S, Corallo G, Mandal? M, Ramat S. The functional head impulse test: Comparing gain and percentage of correct answers Prog Brain Res.2019;248:241-248)

[0012] Nowadays, according to the knowledge of the applicant, it is not known if the VOR can? be related to hearing impairment.

[0013] The "head impulse test" is based on the said second law of Ewald and makes it possible to identify a pathological state even when adaptation processes have taken place. Although it was conceived to study the functionality? of the horizontal semicircular canals, ? was then also applied to the other pairs of semicircular canals.

[0014] The rehabilitation of the VOR has shown, in addition to bringing benefits to the vestibular system as demonstrated by the existing nomenclature, to bring benefits to the entire word comprehension system as it interacts with the central nervous system which ? responsible for listening comprehension and focus.

[0015] The modulated frequency amplification performed by hearing aids, in the case of hearing disorders nowadays, only partially solves the problem of understanding and in any case forces people affected to wear hearing devices that amplify sounds and they do not teach and rehabilitate hearing and the internal system of understanding sound or the phrase itself.

Summary of the invention

[0016] The problem addressed by the present invention? then to provide a device that pu? be effectively used in the treatment of hearing, comprehension and focus disorders. In particular, said device is to be used both in the phase of prevention of hearing disturbances and in treatment, using a datum coming from said device which is used to fine-tune the prevention or treatment itself.

[0017] Finally, a further problem? the development of a diagnostic method which allows to identify patients potentially able to develop this understanding problem.

[0018] ? A device and a method have now been identified which make it possible to treat hearing disorders, both in the preventive and/or rehabilitative phase.

[0019] Further characteristics and advantages of the medical use of the device of the invention will result from the description of the embodiments of the invention, given as an indication of the invention.

Brief description of the figures

FIGURE 1 shows an embodiment of the invention applied to the treatment of hearing disorders.

[0021] FIGURE.2 shows the embodiment of the invention, and highlights the (angular) movement of the head.

Detailed description of the invention

[0022] In the present invention and unless otherwise provided, the following definitions are considered.

[0023] "Angular acceleration" ? defined as the speed? of speed variation? angular in time and pu? be expressed in degrees or radians per second squared (? / s<2 >or rad / s<2 >). "Passive movements" refer to movements imposed on the patient's head by the clinician, for example, carrying the patient's head between hands placed on the cranio-parietal bones and rotating the head some extent to the left or right about its vertical axis . As a result, the patient cannot predict direction, speed? n? the angle of rotation determined by said movement.

[0024] "Active rotation" refers to the movement actively made by the patients themselves by rotating their head.

[0025] "Passive rotation" refers to movement passively made by a person to the patient himself by rotating his head.

[0026] Is the "loss" to be understood as the complete loss of sensitivity? of an SCC, which leads to the patient being completely deprived of vestibular rotational information and therefore to the inability to correctly stabilize the gaze in space and impaired balance.

[0027] "Hypofunctionality or impairment," on the other hand, refers to any minor or severe damage to the gaze stabilization and balance systems caused by auditory or vestibular impairments. Damage can occur due to infections, inflammatory events, pathologies, side effects of drug treatment, accidents, trauma or old age.

[0028] "Optotype line" refers to an array of letters on an optotype diagram used to assess acuity? vision of a patient, such as the Snellen diagram, the E.

[0029] Graph, Landolt C graph or Golovin-Sivtsev graph (for a general reference, see, for example, Ricci F. Cerulli L. : "Standardization of the evaluation criteria of visual acuity". Proceedings I; Congress of the Italian Society Medicina Legal Oculisticas, pag 35-51 Mattioli Ed.1994).

[0030] "Visual target" refers to any images, such as drawings, symbols, numbers or letters of different sizes, which the patient must recognize and read.

[0031] A "Sloan letter" refers to a visual target selected from the capital letters S, O, C, D, K, V, R, H, N or Z.

[0032] "Rotation angle" ? defined as the angle lying on the transversal plane and included between the position of a fixed point of the patient's head in the initial position and the position of the same point reached after that ? rotation has been set. Said corner can be expressed in degrees or radians. When rotational movements are produced manually, pu? some degree of error occur, for example ? 5? with respect to the declared angle of rotation.

[0033] An object of the present invention ? a device comprising:

- one or more unit? of audio output (0)

- one or more unit? display (1),

- a unit? head rotational acceleration measuring device (2) e

- a unit? registration, control and processing (3);

for use in the treatment of hearing disorders, preferably, for use in the treatment of hearing and vestibular problems such as, for example, deafness, tinnitus, unbalance.

[0034] And? was in fact surprisingly found that this device can? be used effectively to prevent the onset of hearing and understanding disorders or in the treatment of hearing and understanding disorders.

[0035] Auditory disorders are hypoacusia, tinnitus, deafness or other hearing impairments that do not permit proper listening and understanding, or a combination of these impairments. Therefore said device pu? be effectively used to prevent and/or treat hearing disorders such as hearing loss, tinnitus, deafness or other hearing disorders that do not allow correct listening and understanding or a combination of these disorders, or, the disorder ? imbalance or dementia or other disorders that do not allow correct listening and understanding.

[0036] The unit? audio output (0) consists of a speaker or headphones or other device capable of outputting sound.

[0037] The unit? sound output (0) creates a sound or a combination of sounds.

[0038] The unit? display (1), which shows the letter to be recognized by the patient, ? positioned at an appropriate distance, for example between 30 and 350 cm, or approximately 150 cm in front of the patient, according to standard clinical procedures.

[0039] The unit? display (1) creates a letter, a number or an avatar.

[0040] The unit? display (1) pu? be any means suitable for displaying a visual target for a period of time on the order of a few milliseconds. For example, can be a screen in which the visual objectives are displayed or projected or pu? be a computer monitor.

[0041] The unit? rotational acceleration measurement (2) ? a device able to measure the angular acceleration, in particular, determined by the rotation imparted to the patient's head by the doctor. Consequently, a gyroscope and/or an accelerometer may be used, which offer the advantage of being easy to handle. The unit? The rotational acceleration measuring device (2) must be positioned so that it rotates simultaneously (integrally) with the patient's head, so that they move together. For example, can be provided a helmet or headband in which the gyroscope (see, for example, figure 1 or 2) and/or the accelerometer are attached to it. In the case of 2 accelerometers, they must be positioned on opposite sides of the axis of rotation (for example one on the forehead and the other on the back of the neck to measure angular accelerations in the horizontal plane). The measured value of the angular acceleration pu? be acquired by the device itself or, in an alternative embodiment, said unit? (2) can? be connected directly to a unit? of registration (3), that ? able to record and memorize the rotational acceleration data introduced or acquired directly from the unit? (2).

[0042] The unit? head rotational acceleration measuring device (2) positioned in the patient's head ? been equipped with a mode? of communication to the other parts of the device which provides for a calculation such as to prepare the correct test and examination. It calculates the correct movement of the head in terms of peak acceleration and peak speed?' providing the unit? of visualization the information on speed?' and transmission time.

[0043] The device intended as a set of unit components? of audio output (0), unit? display (1) (Reader), the unit? of measurement of the rotational acceleration of the head (2) (Sensor) and unit? recording, control and processing (3), ? equipped with an algorithm that allows the display time on the unit? display is always correct for a specific exam, regardless of the variables in the field and the transmission times which may vary. The times could vary in relation to variables such as times useful for the unit? display or processing times. The device for hearing impairments delays the display time data in order to allow it to be viewed by a healthy subject for longer. times compared to a pathological subject. Noting normality? found in scientific research? been found that a certain time resulted in a positive response to the view of 85% by the healthy and reports this speed? on the unit? of diagnosis and screening making sure that it is calibrated correctly with respect to the unit? of main detection itself.

[0044] The unit? of measurement of the rotational acceleration of the head (2) pu? be composed of an optical reader or camera at very high speed?' which detects head movement.

[0045] The unit? of measurement of the rotational acceleration of the head (2) pu? be an optical device for reading the movement of the head that calculates its speed?' angular, even in the absence of a sensor (gyroscope and/or accelerometer), but with the simple computerized visual analysis of the movement of the head.

[0046] The device calculates and modulates the display time in relation to the fact that the diagnosis of hearing disorders has an average response and an average letter display time which ? been estimated to be around 85% (but may vary with further research and data).

[0047] In a preferred embodiment, the unit? of units registration, control and processing (3) pu? be computer software.

[0048] The unit? recording, control and processing (3) ? also able to record the patient's response. In fact, once the patient has read and recognized the letter shown or the file listened to or the combination of the same, will he communicate it? to the doctor, who will introduce? this result in the unit? registration (3). Alternatively, the patient himself can enter the answer in the unit? (2), for example, with the use of a keyboard or recorder in the preferred embodiment, where the unit? registration (3) ? a computer software.

[0049] The unit? of registration, control and processing (3), also includes a part that deals with the control of the answers received from the patient in any form and processes them.

[0050] Dictation of unit? of recording, control and processing (3) acquires data on the patient's responses, analyzes and acquires data on the rotational acceleration value achieved or the level of understanding achieved in the audio file.

[0051] In a preferred embodiment, the unit? registration (3) pu? be represented by computer software.

[0052] A unit? control through a push-button panel, a reworked voice command, one or more? inertial sensors on the human body or a control through a consumer EEG devices (other patents mention the consumer EEG) example EEG-based brain activity monitoring devices (see US20170071495A1) unit? acting simultaneously or selectively.

[0053] A unit? of processing which, in relation to the answers given by the patient, (through the control devices) displays other images and sounds to proceed with the rehabilitation of the hearing disorders described above.

[0054] The unit? of processing ? also connected to the unit? display (1), in order to receive information on the letter shown or audio sent and compare it with the answer provided by the patient. In particular, when they match, the patient's response will be? correct or positive, otherwise sar? wrong or nothing. The unit? of processing ? able to analyze the collected results and the patient's response in each set of experiments and to provide an output, which can be in any suitable form, such as signs, tables or graphs, such as the bar graph, where the x and y axes show, for example, the value of rotational acceleration and the frequency of hits, respectively.

[0055] Consequently, the frequency trend of the positive results with increasing rotational acceleration would become so? obvious. In a further embodiment, the unit? processing can? provide an output in the form of signals, visual signal, for example through the unit? display (1) or an audible signal, by any suitable means connected to it, informing, for example, the doctor about the correctness of each answer, by comparing the answer shown on the unit? display (1) and the patient's response.

[0056] According to a preferred embodiment, the unit? display (1) pu? be a video, cell phone screen or reality display video? virtual or reality? increased.

[0057] According to a preferred embodiment, the unit? display (1) pu? be a video, cell phone screen or reality display video? virtual or reality? augmented by an image or series of images.

[0058] According to a preferred embodiment, ? the use in which the display unit (1) shows words and/or phrases, images or avatars that identify one or more? sounds and asks the patient to identify sounds and images during head movement, preferably as described in claims 5 to 8.

[0059] According to a preferred embodiment, the unit? for measuring the rotational acceleration of the head (2) ? positioned in such a way as to rotate contextually (integrally) with the patient's head.

[0060] According to a preferred embodiment, the unit? of measurement of the rotational acceleration of the head (2) pu? be constituted by a gyroscope and/or an accelerometer, or can? be an optical reader or ultra-high-speed camera?' which detects head movement.

[0061] According to a preferred embodiment, the unit? display (1) pu? be a screen on which visual objectives are displayed or projected.

[0062] According to a preferred embodiment, the unit? display (1) pu? be a computer monitor.

[0063] According to a preferred embodiment, the unit? registration, control and processing (3) pu? be computer software.

[0064] According to a preferred embodiment, the unit? recording, control and processing (3) records data regarding rotational acceleration values and patient responses.

[0065] According to a preferred embodiment, the unit? of recording, control and processing (3) records the received voice and/or audio response of the patient.

[0066] According to a preferred embodiment, the patient's response is introduced by the patient himself into the unit. the unit? registration, control and processing (3).

[0067] According to a preferred embodiment, the unit? recording, control and processing (3) ? connected to the unit? rotational acceleration measuring device (2).

[0068] According to a preferred embodiment, the unit? of recording, control and processing (3) analyzes the results collected on rotational acceleration and patient responses.

[0069] According to a preferred embodiment, the unit? recording, control and processing (3) ? connected to the unit? display (1).

[0070] According to a preferred embodiment, the unit? recording, control and processing (3) provides an output.

[0071] According to an embodiment more? preferred, said output pu? be in the form of signals, tables or graphs.

[0072] According to a preferred embodiment, the treatment of hearing disorders, performed with the above device, can be performed in the preventive and rehabilitative phase.

[0073] According to a preferred embodiment, in the device ? integrated analysis of the functional level of the vestibulo-ocular reflex (VOR) to allow the development of prevention and/or hearing disorders.

[0074] According to a preferred embodiment, does the functional level of the VOR of a subject have a deficit calculated by means of the aforementioned device at the moment of investigation of the impulsive, active or passive head movement? ranging from 100 degrees/s<2 > to 20,000 degrees/s<2 > of peak acceleration of the movement of the head, said movement ranging from 2 degrees to 45 degrees, preferably about 10 degrees on average.

[0075] According to a preferred embodiment, does a subject's VOR functional level have a deficit calculated by means of the aforementioned device at the moment of investigation of the impulsive, active or passive head movement? between 10 degrees/s to 800 degrees/sec speed? peak head movement, said movement ranging from 2 degrees to 45 degrees, preferably about 10 degrees on average.

[0076] According to a preferred embodiment, the measurement of the functional level of the VOR is performed by displaying in the unit? display (1) of optokinetic confounding backgrounds and/or confusion videos (to increase reading difficulty), in the preventive phase and/or in the rehabilitation phase of hearing disorders.

[0077] According to a preferred embodiment, the device of the invention ? used in combination with melatonin production device. The device for the production of melatonin ? described in international application number WO2019087121A1 in the name of Beon Solutions S.r.l. published on May 9, 2019. In particular, said device for the production of melanin ? capable of generating light radiation in a length range between 350 and 750 nm, preferably in the red region, i.e. from 625 to 740 nm.

[0078] The method for treating subjects suffering from hearing disorders comprises the following steps:

to. position the person to be treated in front of the device described above and view, through the unit? display (1), moving letters, videos, avatars and/or audio files;

b. autonomously making the person's head move with active movements in the direction of the semicircular canals, wherein said movements have an acceleration ranging from 300 to 18,000 degrees/s<2 > of accelerative peak on a movement of the head ranging from 5 to 20 degrees;

c. through the? unit? display (1) display the letter or combination of letters or words, audio and avatar for a period of time ranging from 20 milliseconds to 700 milliseconds and verify the correctness of the display and listening through one or more? responses from the person;

d. through the? unit? registration, control and processing (3), analyze the speed? and the accelerations to which the person does not ? managed to make the correct readings;

And. where the person's reading was found to be correct below 85% of the positive responses of a single view at an acceleration of between 300 and 7000 degrees/s<2 > of maximum acceleration for an appearance time between 30 and 120 milliseconds said person? potentially able to improve his auditory perception, focus and listening process.

[0079] And? was in fact found as an incorrect reading under? 85% positive responses of a single image, avatar or audio file at a speed? variable from 300 to 7000 degrees / s<2 > of maximum acceleration (the maximum speed? acceleration divided by 19.2) for an appearance time between 30 and 120 milliseconds? closely related to the pathology of hearing disorders.

[0080] According to a preferred embodiment, step a) is performed according to the method described below, including the preferred embodiments.

[0081] During the passage a) the person ? required, sitting or standing, to read mail in front of the unit? viewing distance, usually at a suitable distance of e.g. 2 to 250cm, preferably 150cm, as shown in Fig.1.

[0082] In particular, compared to the displayed image, this has a shape that is closer to possible to the displayed sound to be re-enabled. For example, if the patient visualizes his hearing loss with a color or a sound it will be? used the same for rehabilitation and to modulate one's perception of sound during the VOR phase. In fact, the permanence of the image must be between 10-150 milliseconds and, preferably, between 25-95 milliseconds from the moment in which the acceleration of the head reaches the threshold. The person ? required to read and acknowledge it and the response is then recorded in the unit? registration, control and processing (3).

[0083] According to a preferred embodiment, in step a) the person ? held, sitting or standing, to see the change in one's perception of sound on a changing image.

[0084] According to a preferred embodiment, in step a) said graph ? placed in front of him at a distance between about 3 and about 250 centimeters and preferably about 150 centimeters.

[0085] According to a preferred embodiment, in step b) in each experiment of each series of experiments the person ? required to actively rotate the head from left to right.

[0086] According to a preferred embodiment, when the rotational acceleration imparted by said active movements reaches a threshold value, a visual target appears on the unit. display (1).

[0087] According to a preferred embodiment, in phase b) each experiment is repeated for a number of times decided by the doctor on the basis of his experience.

[0088] The rehabilitation described above helps the patient through the auditory and vestibular system to select images and sounds within other images and sounds and to move these and modulate this listening and these images.

[0089] It is therefore a rehabilitation of auditory attention using all systems, the auditory system, the vestibular system and the visual system.

[0090] The construction of the avatar or the image? followed by the same patient in pi? phases ranging from 2 to 900 with a control device such as a mouse or keyboard or other.

[0091] The device creates a sound or a combination of sounds by asking the patient through the control devices to construct that audio file made up of a combination of sounds and words. The patient builds this through successive steps for fine-tuning the file itself. The steps to create the visualization, avatar and sound are variable from 2 to 900.

[0092] The exercise consists in identifying images and sounds in different conditions. Are the different conditions detectable by the units? control or combination of the same parameters. For example, the sensor detects the movement of the head.

[0093] The device identifies the patient's answers which may be correct or incorrect. The system will propose a subsequent question that takes into account that answer.

[0094] The device can ask for an answer to the patient who requires more? unit? of control or control and combination of the same. For example a movement and a word, a prevalent frequency in the portable EEG and a sound, a word and a prevalent EEG frequency.

[0095] The device also comprises a display of the light at frequencies from 350 nm up to 750 nm given by the unit display (1) with a combination of sound given by? unit? audio output (0).

[0096] Through the unit? display (1) proceed with the search for the rehabilitation frequency.

Claims (12)

Claims 1) Device for the treatment of auditory and vestibular disorders or a combination thereof comprising: - one or more unit? of audio output (0), - one or more unit? display (1), - a unit? head rotational acceleration measuring device (2) e - a unit? registration, control and processing (3). 2) Device according to claim 1, wherein the unit? display (1) pu? be a video, cell phone screen or reality display video? virtual or reality? increased. 3) Device according to any one of claims 1 to 2, wherein the unit? measurement of rotational acceleration (2) pu? be constituted by a gyroscope and/or an accelerometer or by an optical device for reading the movement of the head which calculates its speed? angular with computer visual analysis of head movement. 4) Device according to any one of claims 1 to 3, wherein the unit? audio output (0) consists of a speaker or headphones or other device capable of outputting sound. 5) Device according to any one of claims 1 to 4, wherein ? analysis of the functional level of the vestibulo-ocular reflex (VOR) was integrated. 6) Device according to any one of claims 1 to 5, wherein the unit? recording, control and processing (3) ? designed to acquire the data of the patient's responses, to analyze them and to acquire the data of the rotational acceleration value reached or the level of understanding reached of the audio file. 7) Device according to any of the claims from 1 to 6, in which unit? of processing (3) ? connected to the unit? display (1), in order to receive information on the letter shown or audio sent and compare it with the answer given by the patient. 8) Device according to claim 5 in which the unit? display (1) ? suitable for displaying optokinetic confounding backgrounds, videos or avatars. 9) Device according to claim 5 in which the unit? of audio output (0) and the unit? display (1) are able to simultaneously emit both sounds and images respectively. 10) Device according to any of the claims from 1 to 9, wherein said device, by means of the display unit (1) shows words and/or sentences, images or avatars which identify one or more? sounds and asks the patient to identify sounds and images during head movement as per claim 5, 8. 11) Device according to any of the claims from 1 to 10, in which the unit? of processing (3) ? capable of providing an output in the form of a visual signal through the unit? display (1) or an audible signal, by any suitable means connected to it, informing the doctor about the correctness of each answer, by comparison of the answer shown on the unit? display (1) and the patient's response. 12) Device according to any one of the claims from 1 to 11, wherein the auditory disturbances are hypoacusia, tinnitus, deafness, or other hearing disorders that do not allow correct listening and understanding or a combination of these disorders, or, the disorder ? imbalance or dementia or other disorders that do not allow correct listening and understanding.