MRA Therapy Versus CPAP Therapy in Moderate OSAS

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: mandibular repositioning appliance (MRA) (SomnoDent); Procedure: Continuous positive airway pressure (CPAP)

• Registration Number: NCT01588275
• Lead Sponsor: University Medical Center Groningen

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.

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Study Start: 2012-05-24
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRA therapy	mandibular repositioning appliance (MRA) (SomnoDent)	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	Continuous positive airway pressure (CPAP)	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.

Primary Outcome Measures

Name	Time	Method
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years	12 months	Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)

Secondary Outcome Measures

Name	Time	Method
Change in Cardiovascular risk	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 quality of life	3, 6 and 12 months	EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months
Compliance	3, 6 and 12 months	objective compliance by reading out devices subjective compliance by questionnaire
Change in polysomnographic outcomes	3 and 12 months	total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages
Change in activities of daily living	3 and 12 months	Total distance on 6 minutes walking test Number of steps measured with pedometer
Side effects	3, 6 and 12 months	self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP

Trial Locations

Locations (3)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Fryslan, Netherlands

Martini Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands