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
1 other identifier
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedOctober 28, 2019
September 1, 2019
7 months
January 21, 2019
October 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in tongue strength using the IOPI device
Baseline and 6 weeks
Change in tongue endurance using the IOPI device
Baseline and 6 weeks
Study Arms (2)
Study Group
EXPERIMENTALParticipants 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
SHAM COMPARATORParticipants 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.
Interventions
IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.
EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.
Eligibility Criteria
You may qualify if:
- Moderate obstructive sleep apnea syndrome (AHI between 15 and 30 events per hour)
- Poor adherence to continuous positive airway pressure (\< 4h per night)
You may not qualify if:
- Craniofacial malformation
- Use of hypnotic medication
- Had stroke in the past
- Present a concurrent neuromuscular or severe obstructive nasal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ligue Pulmonaire Genevoise
Geneva, 1205, Switzerland
Haute Ecole de Santé Vaud (HESAV)
Lausanne, 1011, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 21, 2019
First Posted
February 19, 2019
Study Start
August 1, 2019
Primary Completion
March 1, 2020
Study Completion
July 1, 2020
Last Updated
October 28, 2019
Record last verified: 2019-09