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临床试验/NCT04013321
NCT04013321已完成不适用

Naturalistic Monitoring and Treatment of Chronic Insomnia

Washington State University2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2020年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
2
主要终点
Sleep Duration

研究概览

简要总结

90 individuals with chronic insomniacs and 30 healthy normal sleepers will have their sleep monitored by the SleepScore Max for 10 weeks. Individuals with chronic insomnia will be randomized into one of three groups (30 subjects in each): a test intervention group, a passive control group, and an active control group. The purpose of the study is to examine if the SleepScore max provides a accurate measurement of sleep relative to a validated, wrist-worn sleep monitor and if a integrated coaching feature within the SleepScore Max facilitates improvement in sleep relative to other gold standard treatment methods.

详细描述

90 chronic insomniacs, carefully screened using the criteria of Chronic Insomnia Disorder according to the International Classification of Sleep Disorders 3 (ICSD-3), will be studied. Additionally, 30 healthy normal sleepers will be included as controls. The duration of study participation will be 10 weeks. All subjects will wear an actigraph during week 1 to record baseline sleep patterns, followed by 8 weeks of recording with the SleepScore Max. During week 10, the subjects will wear the actigraph again to measure post intervention sleep. The healthy subjects will be used as a control to test if the SleepScore Max can track sleep well as compared to actigraphy. The subjects with chronic insomnia will be randomized into one of three groups (30 subjects in each). One of these groups is the test intervention group, in which subjects will track their sleep with the SleepScore Max device and will receive feedback and coaching from the Smartphone app associated with the device. The other two groups will serve as passive and active controls. The passive control group will track their sleep using the SleepScore Max device, but without any feedback or coaching. The active control group will also be tracking their sleep with the device, without feedback or coaching, but they will also undergo online CBTi which is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65
  • Physically and psychologically healthy (except for chronic insomnia for the insomnia participants) as assessed by questionnaires and history
  • No sleep disorders other than chronic insomnia (for insomnia participants only) as assessed by questionnaires and history
  • Has daily access to an iPhone

排除标准

  • Non-English speaking

结局指标

主要结局

Sleep Duration

时间窗: 10 weeks

Quantify sleep duration using SleepScore Max in: * Passive control insomniacs vs healthy controls * Insomnia groups

次要结局

  • Sleep latency(10 weeks)
  • Intermittent wakefulness(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Devon Hansen

Assistant Professor

Washington State University

研究点 (2)

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