Reinforcement of Upper Airway Muscles in Patients With OSAS

Haute Ecole de Santé Vaud

Status: Unknown

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: IOPI; Device: EMT threshold

Study type: Interventional

Funder types: Other

Identifiers

NCT03846349

UAW strenghtening in OSAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Study Group

Experimental group

Description:

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

Treatment:

Device: IOPI

Control group

Sham Comparator group

Description:

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.

Treatment:

Device: EMT threshold