NCT05780983已完成不适用
Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Sleep Efficiency
研究概览
简要总结
To finalize daytime intervention components for a comprehensive sleep-wake intervention for frail older adults and explore feasibility and acceptability using a pilot trial.
详细描述
An enhanced intervention addressing both nighttime and daytime activities will be developed based on prior evidence and further informed by data. A successive cohort design will be utilized to evaluate and refine key intervention components and gather feedback on older adults' experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 or over
- •One or more outpatient primary care visits to Wake Forest Baptist Health in the prior 12 months
- •Meets diagnostic criteria for Insomnia Disorder
- •Less than 30 minutes of daily activity or less than 150 minutes total weekly activity for one month or longer, as reported on brief telephone screener
- •Able to ambulate safely (with or without an assistive device)
- •Able to follow study directions
- •Able to communicate and follow study instructions
- •English speaking
排除标准
- •Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg syndrome)
- •Serious or unstable medical or psychiatric condition that would prevent participation in a behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder, substance abuse disorder)
- •Lack of decision-making capacity, as documented in medical record
- •Referred to institutional care and/or currently residing in a nursing home or other residential facility
结局指标
主要结局
Sleep Efficiency
时间窗: Month 2
Total number of minutes asleep divided by total time in bed measure by wrist actigraph
次要结局
- Insomnia Severity Scores(Month 2)
- Total Daytime Activity(Month 2)
- Pittsburgh Sleep Quality Index Score(Month 2)
研究者
研究点 (2)
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