Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 2
研究概览
简要总结
The purpose of this study is to examine daytime sleepiness in a community context. This includes examining sleepiness in a large sample in terms of social/behavioral/environmental predictors and health-related outcomes, as well as examining the role of a sleep education intervention in a smaller sample for promoting healthy beliefs/attitudes about sleepiness.
详细描述
Increasing attention has focused on the role of sleep in public health. 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. As such, short sleep represents an unmet public health problem. The community-level daytime impacts of insufficient sleep are still not well characterized, though.
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. Although much of the focus on sleep as a public health issue has been on insufficient sleep at night, relatively little has focused on the role of daytime sleepiness. The investigator's previous work has shown that the prevalence of daytime tiredness is approximately 18-19% among working-age adults in the US. This is in line with other studies, which have estimated the population burden of excessive daytime sleepiness to be between 10-25%. Daytime sleepiness is a well-documented result of sleep deprivation, but it can also be a result of sleep apnea, sleep fragmentation, and other causes. The role of daytime sleepiness as an important dimension of sleep that impacts public health has not been sufficiently explored. The present study aims to examine daytime sleepiness in a large community sample in terms of social/behavioral/environmental predictors and health-related outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
All 28 participants will be randomized to one of two 4-week tracks (N=14 each).
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be included in the study trial, subjects must:
- •Subject is a male or female, 20-60 years of age, inclusive.
- •Subject is not pregnant.
- •Subject obtains a score of >10 on the Epworth Sleepiness Scale, indicating high daytime sleepiness.
- •Subject presents no apparent unstable and/or major medical or psychiatric conditions that may contribute to sleepiness.
- •Subject is fluent in English.
- •Subject is willing to take part in this study.
排除标准
- •Subject is under the age of 20 or over the age of
- •Subject is pregnant.
- •Subject presents apparent unstable and/or major medical or psychiatric conditions that may contribute to sleepiness.
- •Subject is not fluent in English.
- •Subject obtained a score of <10 on the Epworth Sleepiness Scale.
结局指标
主要结局
Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 2
时间窗: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)
This questionnaire assesses habitual sleep behaviors associated with sleep and potential sleep problems.
Changes in Sleep Beliefs Scale (SBS) score for Track 2
时间窗: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)
The SBS is a revised version of the Sleep Hygiene Awareness and Practice Scale. Possessing a simplified scoring method, the SBS consists of the nine most salient questions from the previous scale, along with 11 relevant additions. The scale requires respondents to indicate how certain behaviors (e.g., drug consumption, daytime and evening activities) can influence the quality and quantity of an individual's sleep, with answers ranging from "positive effect" (on sleep) to "negative effect" (on sleep).
Changes in Dysfunctional Beliefs About Sleep Scale score for Track 1
时间窗: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)
Consisting of 28 items, the scale evaluates sleep-related beliefs, querying respondents' expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues, with answers ranging from 0-"Strongly Disagree" to 10-"Strongly Agree".
Changes in Dysfunctional Beliefs About Sleep Scale score for Track 2
时间窗: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)
Consisting of 28 items, the scale evaluates sleep-related beliefs, querying respondents' expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues, with answers ranging from 0-"Strongly Disagree" to 10-"Strongly Agree".
Change of Epworth Sleepiness Scale (ESS) score across specific time points for Track 1
时间窗: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks).
ESS is a standard measure to assess daytime sleepiness and consists of 8 items ranging from "No chance of dozing" to "High chance of dozing" that evaluate sleep propensity in a range of situations.
Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 1
时间窗: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)
This questionnaire assesses habitual sleep behaviors associated with sleep and potential sleep problems.
Change of Epworth Sleepiness Scale (ESS) score across specific time points for Track 2
时间窗: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).
ESS is a standard measure to assess daytime sleepiness and consists of 8 items ranging from "No chance of dozing" to "High chance of dozing" that evaluate sleep propensity in a range of situations.
Changes in Sleep Beliefs Scale (SBS) score for Track 1
时间窗: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)
The SBS is a revised version of the Sleep Hygiene Awareness and Practice Scale. Possessing a simplified scoring method, the SBS consists of the nine most salient questions from the previous scale, along with 11 relevant additions. The scale requires respondents to indicate how certain behaviors (e.g., drug consumption, daytime and evening activities) can influence the quality and quantity of an individual's sleep, with answers ranging from "positive effect" (on sleep) to "negative effect" (on sleep).
次要结局
- Sleep Timing Questionnaire (STQ)(Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).)
- Sleep Disorders Symptom Check List(Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).)
- Generalized Anxiety Disorder 7- Item Scale (GAD-7)(Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).)
- Medical History(Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).)
- Patient Health Questionnaire (PHQ9)(Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).)
- Qualitative Themes in Sleep Beliefs (Discussed in a group setting)(Focus Group [Day 0])
- Demographics and Personal Information(Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).)
- Insomnia Severity Index (ISI)(Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).)
- Fatigue Severity Scale (FSS)(Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).)
研究者
Michael A. Grandner
Associate Professor of Psychiatry, Psychology, and Medicine; Director, Sleep & Health Research Program, University of Arizona
University of Arizona