跳至主要内容
临床试验/NCT04697680
NCT04697680撤回不适用

Efficacy of a Novel Sleep Intervention in Short Sleepers

University of Arizona2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
150
试验地点
2
主要终点
Change in Sleep Duration

研究概览

简要总结

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. 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 35 % 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. 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.

Previous studies have associated habitual short sleep duration with important adverse cardiometabolic outcomes, including weight gain, obesity, diabetes, cardiovascular disease, stress, etc. They suggest that those that report short sleep may be more likely to experience functional impairments and are less likely to engage in behaviors consistent with a healthy lifestyle. A proposed mechanism of these relationships is that insufficient sleep duration triggers metabolic disturbances and increased immune response resulting in appetite dysregulation, adverse cardiovascular outcomes, and resultant disease states. In addition to cardiometabolic effects, behavioral and functional consequences of short sleep have been well-documented. For example, short sleepers are more likely to exhibit difficulties initiating and/or maintaining sleep daytime sleepiness drowsy driving, and other impairments as a result of sleep loss. Laboratory studies have extensively documented neurocognitive and behavioral effects of sleep loss, including increased objective sleepiness, impaired vigilance using computer-based psychomotor assessments, and deficits in working memory, decision-making, and executive function, as assessed using standardized neuropsychologic and neuroimaging techniques.

Most, if not all, sleep disorders have targeted interventions. Interventions have not been developed or evaluated for insufficient sleep. An effective and disseminable intervention for insufficient sleep will likely differ from those of sleep disorders- rather than an in-clinic, visit-based, medication/device/procedure-focused, non-tailored approach, a successful approach for insufficient sleep will likely be out-of-clinic, population/community-based, lifestyle-focused, and individually-tailored. The problem of insufficient sleep is less like other sleep disorders and more like other health behaviors, such as smoking, poor diet, and lack of physical activity, in that the reasons for insufficient sleep involve beliefs and attitudes, home and work demands, and environmental constraints.

With this in mind, a behavioral intervention was developed based on concepts originally implemented in Cognitive Behavioral Therapy for Insomnia (CBTI), the most well-supported treatment approach for insomnia. Although CBTI does not routinely increase sleep duration, it has sleep efficiency as its primary endpoint and employs concepts that can potentially be used to increase sleep time while maintaining high levels of sleep efficiency. The intervention originally developed included algorithms that recognize the natural "ebb and flow" of sleep ability within an individual seek to use an individual's own sleep data to predict (1) when is an optimal time to make a change to sleep, and (2) what sort of incremental change should be made with the eventual goal of increasing sleep efficiency and duration.

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. 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
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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

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
  • Do not have a typical sleep schedule of <6 hours per night

结局指标

主要结局

Change in Sleep Duration

时间窗: Change in sleep duration from baseline and then every 7 days, over a period of 8 weeks.

Sleep duration will be assessed using Fitbit devices and/or sleep diaries.

Change in Sleep Efficiency

时间窗: Change in sleep efficiency from baseline and then every 7 days, over a period of 8 weeks.

Sleep efficiency will be manually calculated using information from Fitbit devices and/or sleep diaries.

次要结局

  • Change in Pittsburgh Sleep Quality Index (PSQI) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in Insomnia Severity Index (ISI) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change of Epworth Sleepiness Scale (ESS) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in Perceived Stress Scale (PSS) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in Profile of Mood States (POMS) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in Patient Health Questionnaire (PHQ9) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in Sleep Disorders Symptom Check List (SDSCL) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in Brief Index of Sleep Control (BRISC) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in Generalized Anxiety Disorder 7- Item Scale scores (GAD-7) across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Changes in The STOP-Bang questionnaire scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in Positive and Negative Affect Scale (PANAS) across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in The Circadian Energy Scale (CIRENS) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in the Three Factor Eating Questionnaire (TFEQ) scores across an eight (8) week study.(Change from baseline and then at end of study [Day 57])
  • Change in Assessment of Sleep Environment (ASE) scores across an eight week study.(Change from baseline and then at end of study [Day 57])
  • Changes in International Physical Activity Questionnaire (IPAQ) scores across an eight week study.(Change from baseline and then at end of study [Day 57])
  • Change in Dietary Screening Questionnaire (DSQ) scores across an eight week study.(Change from baseline and then at end of study [Day 57])
  • Changes in Health and Performance Questionnaire (HPQ) Question A9 scores across an eight week study.(Change from baseline and then at end of study [Day 57])
  • Change in the Questionnaire on Use of Evening Electronics (QUEEN) scores across an eight (8) week study(Change from baseline and then at end of study [Day 57])
  • Change in the Fatigue Severity Scale (FSS) across an eight (8) week study.(Change from baseline and then at end of study [Day 57])
  • Change in Work Hours and Timing Questionnaire scores across an eight (8) week Study([Time Frame: Change from baseline and then at end of study [Day 57])
  • Change in Sleep Continuity questionnaire scores across an eight (8) weeks study([Time Frame: Change from baseline and then at end of study [Day 57])

研究者

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

MICHAEL A GRANDNER

Director of Sleep and Health Research Program, Associate Professor

University of Arizona

研究点 (2)

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