MRA Therapy Versus CPAP Therapy in Moderate OSAS

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Device: mandibular repositioning appliance (MRA) (SomnoDent)
* Procedure: Continuous positive airway pressure (CPAP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who have been subjected to polysomnography and are diagnosed as having moderate (AHI 15-30) OSAS; Aged ≥ 18 years; Exclusion Criteria: Medical and psychological criteria: Patients previously treated for OSAS (e.g. CPAP, MRA); Morphologic abnormalities of the upper airway (e.g., a compromised nasal passage, enlarged tonsils or adenoids, or upper airway soft-tissue or craniofacial abnormality); Reported or documented unstable endocrine dysfunction (hypothyroidism, acromegaly, or pituitary adenoma); Reported or documented severe cardiovascular- or pulmonary co-morbidity Clinically concurrent cardiovascular disease (coronary artery disease, heart failure,cardiac arrhythmias) CVA within 6 months prior to randomisation Daytime respiratory insufficiency Severe Chronic Obstructive Pulmonary Disease (COPD) (GOLD 3 or 4; FEV1 / FVC < 70% and FEV1 < 50%); Other diseases that may impact the evaluation of the results of the study according to the investigator's judgement. Reported or documented psychological condition precluding informed consent (e.g., mental retardation, depression or schizophrenia); 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: Extensive periodontal disease or tooth decay; Active temporomandibular joint disease (including severe bruxism); Restrictions in mouth opening (< 25mm) or advancement of the mandible <5mm); Partial or complete edentulism (less than eight teeth in upper or lower jaw).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MRA therapy<br>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)<br>* bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula<br>* Other names: bibloc SomnoDent;|
| Active Comparator: CPAP therapy<br>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)<br>* Proper CPAP-pressure will be set for each patient separately.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cost-effectiveness, effectiveness, treatment, CPAP, MRA, compliance