Reinforcement of Upper Airway Muscles in Patients With OSAS

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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: IOPI; Device: EMT threshold

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Genève, Switzerland, 1205
    • Not yet recruiting
    • Ligue Pulmonaire Genevoise
    • Contact: Olivier Contal, PhD; Phone Number: +41213168122; Email: olivier.contal@hesav.ch
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Haute Ecole de Santé Vaud (HESAV)
    • Contact: Olivier Contal, PhD; Phone Number: +41213168122; Email: olivier.contal@uclouvain.be
    • Sub-Investigator: William Poncin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; 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; IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.
Sham Comparator: Control group; 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; EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Haute Ecole de Santé Vaud

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: UAW strenghtening in OSAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No