Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 6
- 主要终点
- Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who have been subjected to polysomnography and are diagnosed as having moderate (AHI 15-30) OSAS;
- •Aged ≥ 18 years;
排除标准
- •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).
研究组 & 干预措施
MRA therapy
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.
干预措施: mandibular repositioning appliance (MRA) (SomnoDent) (Device)
CPAP therapy
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.
干预措施: Continuous positive airway pressure (CPAP) (Procedure)
结局指标
主要结局
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years
时间窗: 12 months
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)
次要结局
- Change in Cardiovascular risk(6 and 12 months)
- Change in quality of life(3, 6 and 12 months)
- Compliance(3, 6 and 12 months)
- Change in polysomnographic outcomes(3 and 12 months)
- Change in activities of daily living(3 and 12 months)
- Side effects(3, 6 and 12 months)
研究者
Grietje E de Vries, MSc
researcher/project leader
University Medical Center Groningen