Obstructive Sleep Apnea Syndrome
Conditions
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.
Interventions
DEVICEIOPI
IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.
DEVICEEMT threshold
EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.
Sponsors
Haute Ecole de Santé Vaud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Contacts
Primary ContactOlivier Contal, PhD
Backup ContactWilliam Poncin, PhD
Outcome results
None listed