Clinical trial NCT01588275: MRA Therapy Versus CPAP Therapy in Moderate OSAS
Official title: Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: cost-effectiveness
effectiveness
treatment
CPAP
MRA
compliance
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: VitalAire Nederland BV
name: SomnoMed Goedegebuure
First posted: 2012-04-30
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years
timeFrame: 12 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: 3, 6 and 12 months
measure: Change in Cardiovascular risk
timeFrame: 6 and 12 months
measure: Change in polysomnographic outcomes
timeFrame: 3 and 12 months
measure: Change in activities of daily living
timeFrame: 3 and 12 months
measure: Compliance
timeFrame: 3, 6 and 12 months
measure: Side effects
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Fryslan
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Grietje E de Vries, MSc
role: STUDY_CHAIR
affiliation: University Medical Center Groningen
name: Peter J Wijkstra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.