Reinforcement of Upper Airway Muscles in Patients With OSAS

Not Applicable

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: IOPI; Device: EMT threshold

• Registration Number: NCT03846349
• Lead Sponsor: Haute Ecole de Santé Vaud

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-19
• Study Start: 2019-08-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-28
• Primary Completion: 2020-03-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	IOPI	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
Control group	EMT threshold	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in tongue strength using the IOPI device	Baseline and 6 weeks	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.
Change in tongue endurance using the IOPI device	Baseline and 6 weeks	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.

Trial Locations

Locations (2)

Ligue Pulmonaire Genevoise; 🇨🇭 Genève, Switzerland

Haute Ecole de Santé Vaud (HESAV); 🇨🇭 Lausanne, Switzerland