Trials / Completed
CompletedNCT01588275
MRA Therapy Versus CPAP Therapy in Moderate OSAS
Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the cost-effectiveness and effectiveness of mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP) therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS).
Detailed description
Study design: In a randomized parallel controlled study 86 patients will be randomly assigned to either MRA therapy or CPAP therapy. Group A receives MRA. Group B receives CPAP. The total duration of the study is 12 months. Measurements will be done at baseline, after 3, 6 and 12 months. Intervention: Group A will be treated with a bibloc MRA (Somnodent). The mandible will be set at 70% of the patient's maximum advancement and will be adjusted to the convenience of the patient. Titration will be continued until symptoms abate or until further advancement causes discomfort. Group B will be treated with CPAP. Proper CPAP-pressure will be set for each patient separately. Patients are fitted with a comfortable CPAP mask before titration of the CPAP-pressure. For CPAP-titration, patients are instructed to adopt their own typical sleeping habits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | mandibular repositioning appliance (MRA) (SomnoDent) | bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula |
| PROCEDURE | Continuous positive airway pressure (CPAP) | Proper CPAP-pressure will be set for each patient separately. |
Timeline
- Start date
- 2012-05-24
- Primary completion
- 2017-12-31
- Completion
- 2017-12-31
- First posted
- 2012-04-30
- Last updated
- 2018-05-15
Locations
3 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01588275. Inclusion in this directory is not an endorsement.