Reinforcement of Upper Airway Muscles in Patients With OSAS

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03846349
• Other study ID #: UAW strenghtening in OSAS
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2019
• Source: Haute Ecole de Santé Vaud
• Contact: Olivier Contal, PhD
• Phone: +41213168122
• Email: olivier.contal[@]hesav.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• IOPI
IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.
• EMT threshold
EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.

Locations

Country	Name	City	State
Switzerland	Ligue Pulmonaire Genevoise	Genève
Switzerland	Haute Ecole de Santé Vaud (HESAV)	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Haute Ecole de Santé Vaud

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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