Clinical trial NCT04176042: Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea
Official title: Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Daytime Sleepiness
Keywords: Daytime Sleepiness
Environmental Determinants
Sleep Beliefs
Sleep Attitudes
Educational Intervention
Focus Group
Epworth Sleepiness Scale
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Jazz Pharmaceuticals
First posted: 2019-11-25
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4-WEEK TRACKS All 28 participants will be randomized to one of two 4-week tracks (N=14 each). The study design (crossover) dictates that all participants must complete a questionnaire at identical time points; therefore, participants in track 2 will perform a baseline questionnaire at the same time as track 1 participants perform a baseline questionnaire for their intervention. Also, participants in track 1 will complete the follow up at the same time as track 2 participants perform a baseline questionnaire for their intervention.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* Subject is under the age of 20 or over the age of 60.
* 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.

Primary outcomes:
measure: Change of Epworth Sleepiness Scale (ESS) score across specific time points for Track 1
timeFrame: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks).
measure: Change of Epworth Sleepiness Scale (ESS) score across specific time points for Track 2
timeFrame: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).
measure: Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 1
timeFrame: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)
measure: Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 2
timeFrame: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)
measure: Changes in Sleep Beliefs Scale (SBS) score for Track 1
timeFrame: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)
measure: Changes in Sleep Beliefs Scale (SBS) score for Track 2
timeFrame: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)
measure: Changes in Dysfunctional Beliefs About Sleep Scale score for Track 1
timeFrame: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)
measure: Changes in Dysfunctional Beliefs About Sleep Scale score for Track 2
timeFrame: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)
Secondary outcomes:
measure: Qualitative Themes in Sleep Beliefs (Discussed in a group setting)
timeFrame: Focus Group [Day 0]
measure: Demographics and Personal Information
timeFrame: 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).
measure: Medical History
timeFrame: 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).
measure: Fatigue Severity Scale (FSS)
timeFrame: 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).
measure: Sleep Timing Questionnaire (STQ)
timeFrame: 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).
measure: Insomnia Severity Index (ISI)
timeFrame: 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).
measure: Sleep Disorders Symptom Check List
timeFrame: 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).
measure: Patient Health Questionnaire (PHQ9)
timeFrame: 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).
measure: Generalized Anxiety Disorder 7- Item Scale (GAD-7)
timeFrame: 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).
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Department of Psychiatry Research Facilities
state: Arizona
Study officials:
affiliation: University of Arizona
name: Michael A. Grandner, PhD, MTR
role: PRINCIPAL_INVESTIGATOR
References: