Reinforcement of Upper Airway Muscles in Patients With OSAS

Study Overview
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Brief Summary
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This study will investigate the effectiveness of a simple and quick myofunctional reeducation protocol of the tongue in reducing the obstructive sleep apnea syndrome (OSAS) severity.

Detailed Description
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This is a randomized controlled study. Participants with moderate OSAS severity will be either allocated to receive a myofunctional reeducation protocol (study group) or a sham protocol (control group). Apnea-hypopnea index (AHI) will be measured before and at the end (6 weeks) of the protocol. Participants from the study group will follow an upper airway reinforcement regimen using the IOPI (Iowa Oral Performance Instrument) device over 6 weeks while participants from the control group will perform a sham reeducation protocol using an EMT threshold at minimal resistance.

Official Title
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Non-invasive Reinforcement of the Upper Airway Dilator Muscles as an Alternative Approach to Treat Patients With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: IOPI
* Device: EMT threshold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate obstructive sleep apnea syndrome (AHI between 15 and 30 events per hour) Poor adherence to continuous positive airway pressure (< 4h per night) Exclusion Criteria: Craniofacial malformation Use of hypnotic medication Had stroke in the past Present a concurrent neuromuscular or severe obstructive nasal disease

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants from the study group will follow an upper airway reinforcement regimen using the IOPI device over 6 weeks. The reinforcement protocol will be adapted each week to improve Percentage of initial strength Exercises will be adapted each week | Device: IOPI<br>* IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.<br>|
| Sham Comparator: Control group<br>Participants from the control group will perform a sham reeducation protocol using an EMT threshold at minimal resistance. The expiratory pressure will remain unchanged over the weeks. | Device: EMT threshold<br>* EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AHI (apnea-hypopnea index) on polygraphy | Evolution of the number of apnea-hypopnea events (AHI) over 6 weeks. The AHI value at discharge will be compared with the baseline value. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tongue strength using the IOPI device | Evolution of tongue strength over 6 weeks. Tongue strength will be measured by asking the participants to squeeze the tongue bulb of IOPI as much as possible over 3 seconds. Three trials are accepted and the best value will be recorded (Pmax). Pmax at discharge will be compared with Pmax at baseline. | Baseline and 6 weeks | 
| Change in tongue endurance using the IOPI device | Evolution of tongue endurance over 6 weeks. Tongue endurance will be measured by asking the participants to sustain a tongue pressure against the IOPI bulb at 50% of Pmax. Endurance will be assessed by measuring the holding duration of 50% of Pmax. Holding duration at discharge will be compared with the value at baseline. | Baseline and 6 weeks |