Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Nightly CPAP Use
研究概览
简要总结
The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.
详细描述
Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes. Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly. The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.
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
- Triple (Participant, Investigator, 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
- •males and females >/= 18 years of age
- •newly diagnosed with apnea/hypopnea index >/= 10 events/hr
- •CPAP naive
- •able to read and speak English
排除标准
- •previous diagnosis and/or treatment of OSA
- •major new psychiatric diagnosis within 6 months of study enrollment
- •require supplemental oxygen or bilevel positive airway pressure on CPAP titration polysomnogram
- •diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb movements >/= 10 events/hr with arousal, central sleep apnea with >/= 5 central events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy
结局指标
主要结局
Nightly CPAP Use
时间窗: 3 months
Mean CPAP use, hrs/night
次要结局
- Proportion of Participants Who Complete Protocol After Allocation(Duration of protocol period)
- Acceptability of Study Intervention and Comparative Group(3 months)
- Proportion of Sleep Time on CPAP(1 week)
- Proportion of Participants Who Withdrawal(Duration of protocol period)
研究者
Amy M. Sawyer
Assistant Professor
Milton S. Hershey Medical Center