Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Phase 1 Open Label Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Sleep onset latency
研究概览
简要总结
Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia.
详细描述
Open-label pilot study in 20 older adults with insomnia (sleep onset latency>30 minutes for at least 3 nights a week) with a two week intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Sleep onset latency > 30 min for at least 3 nights per week
排除标准
- •Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages).
- •Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol).
- •History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder
- •Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).
研究组 & 干预措施
MBAT
Monitored breathing awareness therapy administered using a mobile device on a nightly basis during sleep onset.
干预措施: MBAT (Behavioral)
结局指标
主要结局
Sleep onset latency
时间窗: two weeks
Time to fall asleep
次要结局
未报告次要终点
研究者
Nalaka Gooneratne
Associate Professor
University of Pennsylvania