MRA Therapy Versus CPAP Therapy in Moderate OSAS (REST)
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|ClinicalTrials.gov Identifier: NCT01588275|
Recruitment Status : Active, not recruiting
First Posted : April 30, 2012
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Device: mandibular repositioning appliance (MRA) (SomnoDent) Procedure: Continuous positive airway pressure (CPAP)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS|
|Actual Study Start Date :||May 24, 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|