An interventional study of mandibular repositioning appliance (MRA) (SomnoDent) and Continuous positive airway pressure (CPAP) in Sleep Apnea, Obstructive, sponsored by University Medical Center Groningen. Completed at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-15.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 86 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medical and psychological criteria:
Whether the patient has unstable endocrine dysfunction, severe cardiovascular- or pulmonary co-morbidity or a psychological condition precluding informed consent, will be assessed by evaluating the patient's medical record.
Dental exclusion criteria:
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)
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)
bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula
Also known as: bibloc SomnoDent
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
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 study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen