Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 2
- 主要终点
- Acceptance of CPAP treatment
研究概览
简要总结
This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.
详细描述
The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches [home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management. The study is designed to compare the utility of the two approaches (PM group vs. Lab group) for the diagnosis and management of OSA in adults. Approximately 372 eligible adults will be randomized at screening to either the PM or Lab arm (186 per arm), undergo baseline OSA testing to confirm diagnosis and study eligibility, then receive positive airway pressure (PAP) titration studies to determine the level of pressure needed to treat their OSA. For qualifying participants, the titration study will be lab-based in the Lab group and be home-based using a commercially available portable, automatic PAP device (APAP) in the PM group. All qualifying study participants will have access to study CPAP equipment and supplies to treat their OSA. Primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting CPAP treatment. Study participants who complete all of their study visits will keep their CPAP machine at the end of the study.
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
- •Intermediate to high probability of having OSA based on an adjusted neck circumference > 43 cm (17 inches)
- •Presence of excessive daytime sleepiness (Epworth sleepiness scale ≥ 12) Apnea-hypopnea index >= 15 on diagnostic testing to continue in study
排除标准
- •Severe chronic insomnia, other condition with < 4 hrs of sleep per night
- •Unstable medical conditions
- •Major psychiatric diagnosis
- •Unable to undergo home testing
- •Concerns about unsafe driving
- •Severe COPD or restrictive lung disease
- •Chronic narcotic use
- •Alcohol abuse
- •History of cataplexy
- •Moderate to severe restless legs syndrome symptoms
- •Pre-existing diagnosis of sleep apnea
- •Prior experience with positive airway pressure treatment of sleep apnea
- •Anticipated upper airway surgery or gastric bypass surgery in 4 months
- •Decisional impairment for consenting
- •Hypoventilation syndrome, identified in the medical record
- •Waking oxygen saturation < 92%
结局指标
主要结局
Acceptance of CPAP treatment
时间窗: from diagnosis to effective treatment
次要结局
- Compliance with CPAP therapy(1 and 3 month post acceptance)