Cost-effectiveness of Obstructive Sleep Apnea Therapy: Comparison of Mandibular Repositioning Appliance Therapy Versus CPAP Therapy in Moderate Obstructive Sleep Apnea Syndrome (REST)

• Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)
  
  

• Change in quality of life [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months
  
  
• Change in Cardiovascular risk [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  smoking status, change from baseline ambulant blood pressure measurements after 12 months, blood samples, urine sample, accumulation of advanced glycation endproducts (AGEs) in skin tissue
  
  
• Change in polysomnographic outcomes [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages
  
  
• Change in activities of daily living [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  Total distance on 6 minutes walking test Number of steps measured with pedometer
  
  
• Compliance [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  objective compliance by reading out devices subjective compliance by questionnaire
  
  
• Side effects [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP
  
  

Study design: In a randomized parallel controlled study 100 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.