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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula
Proper CPAP-pressure will be set for each patient separately.
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Martini Ziekenhuis Groningen
Groningen, Netherlands
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)
Time frame: 12 months
Change in quality of life
EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months
Time frame: 3, 6 and 12 months
Change in Cardiovascular risk
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
Time frame: 6 and 12 months
Change in polysomnographic outcomes
total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages
Time frame: 3 and 12 months
Change in activities of daily living
Total distance on 6 minutes walking test Number of steps measured with pedometer
Time frame: 3 and 12 months
Compliance
objective compliance by reading out devices subjective compliance by questionnaire
Time frame: 3, 6 and 12 months
Side effects
self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP
Time frame: 3, 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.