PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes

Study Overview
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Brief Summary
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This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.

Detailed Description
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Severe sleep apnea patients will undergo two polysomnographies (PSG), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). Comparison of apnea and hypopnea indices (AHI) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: Kinesthetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet all the following criteria at the time of enrollment may be included: Man or woman aged more than 18 years old. Patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (AHI > 30/h and 80% of obstructive events) and (ODI 4% > 20 or time with SaO2 below 90% > 5%). Patient free from continuous positive airway pressure (CPAP) treatment or any other SAS treatment for at least 3 months Patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination Patient was informed and has signed the informed consent Exclusion Criteria: Patients who meet any one of these criteria will be excluded from the study: Patients sleeping less than 4 hours per night Patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension. Patients developing periodic breathing or Cheyne Stokes respiration Obese patient (BMI>35kg/m2) Patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, Parkinson's disease or other primary pathologies. Patient suffering from restless leg syndrome or periodic leg movement (PLM) not related to obstructive sleep apnea, i.e. PLM index > 15/h excluding movements linked to respiratory events. Patient suffering from positional sleep apnea syndrome (SAS), i.e. supine apnea hypopnea index (AHI) at least twice that of the non-supine AHI Patient suffering from severe peripheral neuropathy Vulnerable patient in accordance with article L1121-6 of Code de la Santé Publique (CSP) Patient already involved in another clinical study that could affect the result of this study Pregnant patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment ON<br>Kinesthetic stimulation administered during one night | Device: Kinesthetic stimulation<br>* Activation of mechanoreceptors by vibration bursts<br>|
| No Intervention: Treatment OFF<br>NO kinesthetic stimulation administered during one night | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of responder to the therapy | A patient is defined as 'responder' to the therapy by comparison of the treated night to the non-treated night based on: The oxygen desaturation index (ODI) The time spent below 90% of oxygen saturation or The apnea hypopnea index (AHI) reduction | Day 1 post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse device effect | Adverse Events related to the investigational device | Day 1 post-discharge | 
| Effect on apneas/hypopneas duration | Therapy effect on shortening respiratory events | Day 1 post-discharge | 
| Effect on modified apnea hypopnea index | The modified apnea hypopnea indices (AHIs) will be compared between the treated and non-treated night and defined based on the duration of the respiratory disorders | Day 1 post-discharge | 
| Instantaneous heart rate measurement (bpm) during the night ON and the night OFF |  | Day 1 post-discharge | 
| Number of arousals per night - comparison night ON and night OFF | The micro-arousal index will be calculated on the polysomnography recording. | Day 1 post-discharge | 
| Effect on an objective measure of somnolence (Osler) | Osler test (optional) performed after treated night and non-treated night | Day 1 post-discharge |