Trials / Unknown
UnknownNCT03846349
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Haute Ecole de Santé Vaud · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IOPI | IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles. |
| DEVICE | EMT threshold | EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling. |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2020-03-01
- Completion
- 2020-07-01
- First posted
- 2019-02-19
- Last updated
- 2019-10-28
Locations
2 sites across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT03846349. Inclusion in this directory is not an endorsement.