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临床试验/NCT07345767
NCT07345767招募中不适用

Hypknowledge Nationwide Sleep Extension

University of Arizona1 个研究点 分布在 1 个国家目标入组 1,038 人开始时间: 2026年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,038
试验地点
1
主要终点
Sleep Duration

研究概览

简要总结

The main goal of this study is to evaluate whether a manually determined sleep extension intervention is effective at improving sleep and related outcomes among adults who find it difficult to get enough sleep.

详细描述

Approximately 1/3 of Americans sleep ≤6h per night, an amount that has been deemed sub-optimal by the American Academy of Sleep Medicine and Sleep Research Society, the National Sleep Foundation, American Thoracic Society, and the American Heart Association. These consensus statements echo findings from many reviews on this topic. This is alarming, given epidemiologic and experimental research showing that reduced sleep time is associated with a variety of negative health outcomes including obesity, diabetes, cardiovascular disease, and mortality. Different people may need different amounts of sleep and some people may not be able to make large changes to their sleep schedule all at once. Many individuals have situational constraints that change over time. As such, short sleep represents an unmet public health problem. There are, however, no empirically supported interventions for insufficient sleep. The proposed study addresses this critical gap by evaluating the efficacy of a novel intervention that is theoretically grounded, feasible, and has positive impacts on sleep duration. The intervention in the proposed study is by design self-correcting, individually-tailored, and not dependent on unknown individual sleep needs. It can adapt to any schedule and situation and can adapt to changes in a person's sleep schedule.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be between the ages of 18-60 years old
  • Have a typical sleep schedule of <=6 hours per night
  • Must have a FitBit device (any model) with Heart Rate Monitor
  • Must have bedtime between 8 pm and 1 am
  • Must have a waketime between 5 am and 10 am
  • Must not have insomnia as determined by diagnosis or score on the Insomnia Severity Index (ISI), or must be treated.
  • Must not have sleep apnea as determined by diagnosis or STOP-BANG scale, or must be treated.
  • Must have a computer or smartphone device for daily sleep diaries.
  • Must have an initial sleep efficiency of at least 85% as determined by sleep diaries and actigraphy.

排除标准

  • Any condition that the PI considers would significantly impede participation in the study.
  • Participant is under 18 years of age or older than 60 years of age
  • Does not own a FitBit device with Heart Rate Monitor
  • Sleep >6 hours per night.
  • Typical bedtime before 8 pm or after 1 am
  • Typical waketime before 5 am or after 10 am
  • Diagnosed with sleep disorders including insomnia or sleep apnea
  • Diagnosed mental health disorder which may impact sleep (i.e. Bipolar Disorder)
  • Taking medications that may affect sleep.
  • Baseline sleep efficiency less than 85%.

研究组 & 干预措施

Control

No Intervention

The control group receives standard feedback, where they will be asked to maintain a consistent sleep schedule irrespective of what the Fitbit data or sleep diary report.

Intervention: Sleep Diary

Experimental

This arm receives weekly feedback on their sleep schedule based on sleep diary data.

干预措施: Sleep Diary (Behavioral)

Intervention: Fitbit

Experimental

This arm receives weekly feedback on their sleep schedule based on Fitbit data.

干预措施: Fitbit (Behavioral)

结局指标

主要结局

Sleep Duration

时间窗: 9 weeks from enrollment to the end of the study

Measured in minutes. It is trended from enrollment until the end of the study

次要结局

  • Mental Health(9 weeks from enrollment to the end of the study)
  • Sleepiness/Fatigue(9 weeks from enrollment to end of the study)
  • Cognitive Functioning(9 weeks from enrollment to the end of the study)

研究者

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

MICHAEL A GRANDNER

Associate Professor of Psychiatry

University of Arizona

研究点 (1)

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