Sleep Apnea, Obstructive Clinical Trial
Official title:
Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS
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).
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.
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