临床试验/NCT03187340

NCT03187340进行中（未招募）不适用

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Randomized Study

Nalaka Gooneratne2 个研究点分布在 1 个国家目标入组 112 人开始时间: 2019年6月20日最近更新: 2024年2月8日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 112
试验地点: 2
主要终点: Sleep onset latency

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

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: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 55 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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). 2) Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3) History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4) Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).

结局指标

主要结局

Sleep onset latency

时间窗: four weeks

time to fall asleep

次要结局

未报告次要终点

研究者

发起方

Nalaka Gooneratne

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Nalaka Gooneratne

Associate Professor

University of Pennsylvania

研究点 (2)

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