Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
OBJECTIVES:
To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA).
HYPOTHESIS:
The SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.
STUDY DESIGN:
A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.
STUDY POPULATION:
Patients diagnosed with moderate POSA according to polysomnography (PSG) results.
INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:
The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.
OUTCOME MEASURES:
AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER)
SAMPLE SIZE / DATA ANALYSIS:
100 subjects in each treatment group, total of 200 patients.
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:
The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.
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
- Single (Outcomes Assessor)
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
- •18 years and older
- •Ability to speak, read and write Dutch
- •Ability to follow up
- •Diagnosis with symptomatic moderate OSA (15 < AHI < 30)
- •Diagnosis of 10 to 90% supine position during the night
- •AHI supine is 2 > as high as AHI non-supine
- •Own a Windows PC and ability to install SPT connection software and upload research data
- •Expected to maintain current lifestyle (sports, medicine, diet etc.)
排除标准
- •Many dental problems; insufficient teeth for wearing MRA
- •Medication used/ related to sleeping disorders
- •Central Sleep Apnea Syndrome
- •Night or shifting work
- •Severe chronic heart failure
- •Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy)
- •Seizure disorder
- •Known medical history of mental retardation, memory disorders or psychiatric disorders
- •Shoulder, neck and back complaints
- •Reversible morphological upper airway abnormalities (e.g. enlarged tonsils)
- •Inability to provide informed consent
- •Simultaneous use of other treatment modalities to treat OSA
- •Previous treatment for OSA with MRA, CPAP or SPT
- •Pregnancy
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: change from baseline, after 3, 6 and 12 months
次要结局
- Therapy compliance(change from baseline, after 3, 6 and 12 months)
- Cardiovascular parameters(change from baseline, after 3, 6 and 12 months)
- Outcome of Quality of Life questionnaires(change from baseline, after 3, 6 and 12 months)
- (Societal) costs of treatment(change from baseline, after 3, 6 and 12 months)
研究者
L.B.L. Benoist
Drs.
Onze Lieve Vrouwe Gasthuis