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| Name | Class |
|---|---|
| VitalAire Nederland BV | UNKNOWN |
| SomnoMed Goedegebuure | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRA therapy | Active Comparator | 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. |
|
| CPAP therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mandibular repositioning appliance (MRA) (SomnoDent) | Device | bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months | 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Grietje E de Vries, MSc | University Medical Center Groningen | Study Chair |
| Peter J Wijkstra, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Centrum Leeuwarden | Leeuwarden | Provincie Friesland | 8901 BR | Netherlands | ||
| University Medical Center Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35088708 | Derived | Uniken Venema JAM, Knol-de Vries GE, van Goor H, Westra J, Hoekema A, Wijkstra PJ. Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2022 Jun 1;18(6):1547-1555. doi: 10.5664/jcsm.9908. | |
| 31739856 |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018810 | Magnetic Resonance Angiography |
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Continuous positive airway pressure (CPAP) | Procedure | Proper CPAP-pressure will be set for each patient separately. |
|
| 6 and 12 months |
| Change in polysomnographic outcomes | total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages | 3 and 12 months |
| Change in activities of daily living | Total distance on 6 minutes walking test Number of steps measured with pedometer | 3 and 12 months |
| Compliance | objective compliance by reading out devices subjective compliance by questionnaire | 3, 6 and 12 months |
| Side effects | self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP | 3, 6 and 12 months |
| Groningen |
| 9700 RB |
| Netherlands |
| Martini Ziekenhuis Groningen | Groningen | 9700 RM | Netherlands |
| de Vries GE, Hoekema A, Claessen JQPJ, Stellingsma C, Stegenga B, Kerstjens HAM, Wijkstra PJ. Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Nov 15;15(11):1655-1663. doi: 10.5664/jcsm.8034. |
| 31596213 | Derived | de Vries GE, Hoekema A, Vermeulen KM, Claessen JQPJ, Jacobs W, van der Maten J, van der Hoeven JH, Stegenga B, Kerstjens HAM, Wijkstra PJ. Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Oct 15;15(10):1477-1485. doi: 10.5664/jcsm.7980. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003933 | Diagnosis |
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |