Sleep Apnea, Obstructive
Conditions
Keywords
cost-effectiveness, effectiveness, treatment, CPAP, MRA, compliance
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.
Interventions
DEVICEmandibular repositioning appliance (MRA) (SomnoDent)
bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula
PROCEDUREContinuous positive airway pressure (CPAP)
Proper CPAP-pressure will be set for each patient separately.
Sponsors
VitalAire Nederland BV
SomnoMed Goedegebuure
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 polysomnographic outcomes | 3 and 12 months | total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages |
| 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 |
| Side effects | 3, 6 and 12 months | self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP |
| Change in activities of daily living | 3 and 12 months | Total distance on 6 minutes walking test Number of steps measured with pedometer |
Countries
Netherlands
Outcome results
None listed