临床试验/NCT03072017

NCT03072017已完成不适用

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Phase 1 Open Label Pilot

University of Pennsylvania0 个研究点目标入组 20 人开始时间: 2016年7月1日最近更新: 2017年7月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Pennsylvania
入组人数: 20
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.

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

•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).

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

发起方

University of Pennsylvania

申办方类型

Other

责任方

Principal Investigator

主要研究者

Nalaka Gooneratne

Associate Professor

University of Pennsylvania

相似试验

进行中（未招募）

不适用

Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2Insomnia

NCT03187340Nalaka Gooneratne112

撤回

不适用

Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung CancerLung Cancer

NCT03443908Mark M. Fuster, MD

Enrolling By Invitation

不适用

Study on the Remote Diagnosis and Treatment Strategy of New-onset Insomnia Under the COVID-19 EpidemicInsomniaDepressionCBTAnxiety

NCT05926531Nanfang Hospital, Southern Medical University28

已完成

1 期

Sedative and Hypnotic Effects Induced by EABypass Complications

NCT01896063Xijing Hospital45

已完成

不适用

Acceptance and Commitment Therapy for InsomniaInsomnia

NCT04866914University of Sao Paulo General Hospital227