MRA Therapy Versus CPAP Therapy in Moderate OSAS (REST)
|Sleep Apnea, Obstructive||Device: mandibular repositioning appliance (MRA) (SomnoDent) Procedure: Continuous positive airway pressure (CPAP)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS|
- Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years [ Time Frame: 12 months ]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 ]EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months
- Change in Cardiovascular risk [ Time Frame: 6 and 12 months ]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 ]total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages
- Change in activities of daily living [ Time Frame: 3 and 12 months ]Total distance on 6 minutes walking test Number of steps measured with pedometer
- Compliance [ Time Frame: 3, 6 and 12 months ]objective compliance by reading out devices subjective compliance by questionnaire
- Side effects [ Time Frame: 3, 6 and 12 months ]self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP
|Actual Study Start Date:||May 24, 2012|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Active Comparator: MRA therapy
During 12 months patients will be treated with a bibloc MRA (SomnoDent® MAS, SomnoMed Australia/Europe AG). The MRA will be customized by certified dentists or dental-specialists experienced in the field of dental sleep medicine.
Device: mandibular repositioning appliance (MRA) (SomnoDent)
bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula
Other Name: bibloc SomnoDent
Active Comparator: CPAP therapy
During 12 months patients will be treated with Continuous positive airway pressure (CPAP).Treatment with CPAP prevents upper airway collapse by pneumatically "splinting" the upper airway during sleep.
Procedure: Continuous positive airway pressure (CPAP)
Proper CPAP-pressure will be set for each patient separately.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588275
|Medisch Centrum Leeuwarden|
|Leeuwarden, Fryslan, Netherlands, 8901 BR|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700 RB|
|Martini Ziekenhuis Groningen|
|Groningen, Netherlands, 9700 RM|
|Study Chair:||Grietje E de Vries, MSc||University Medical Center Groningen|
|Principal Investigator:||Peter J Wijkstra, PhD||University Medical Center Groningen|