Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea

NCT ID: NCT04176042

Last Updated: 2020-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2020-06-30

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.

Conditions

Daytime Sleepiness

Keywords

Daytime Sleepiness; Environmental Determinants; Sleep Beliefs; Sleep Attitudes; Educational Intervention; Focus Group; Epworth Sleepiness Scale

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Track 1

Subjects will be randomized to one of two 4-week tracks.

Track 1 (intervention + follow-up) will consist of the following:

Subjects will be randomized to one of two 4-week tracks. Track 1 (intervention + follow-up) will consist of the following: Prior to the session, within 72 hours of the scheduled 2-hour education invention participants will complete a baseline questionnaire battery consisting of measures including demographics, medical history and sleep. After completion, a 2-hour educational presentation will take place with a question-and-answer session. Participants will then complete post-intervention questionnaires to assess immediate impact of the session on knowledge, beliefs and practices. After 4 weeks, Track 1 participants will be contacted and will be asked to re-complete all baseline questionnaires (see above), in order to evaluate changes over 4 weeks.

Group Type: EXPERIMENTAL

Track 1

Intervention Type: BEHAVIORAL

Intervention + Follow-up

Track 2

Subjects will be randomized to one of two 4-week tracks. Track 2 (wait list + intervention) will consist of the following: Prior to the session, within 72 hours of the scheduled 2-hour education invention for Track 1 participants will complete the same baseline questionnaire battery.

An identical intervention session, scheduled 4 weeks into the future. At that time, an identical procedure to the other track will be followed, including the pretest questionnaires, 2-hour session, and post-session assessment. No additional 4-week follow-up will be performed.

Group Type: ACTIVE_COMPARATOR

Track 2

Intervention Type: BEHAVIORAL

Wait list + Intervention

Interventions

Track 1

Intervention + Follow-up

Intervention Type: BEHAVIORAL

Track 2

Wait list + Intervention

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Michael A. Grandner

Associate Professor of Psychiatry, Psychology, and Medicine; Director, Sleep & Health Research Program, University of Arizona

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A. Grandner, PhD, MTR

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona Department of Psychiatry Research Facilities

Tucson, Arizona, United States

Countries

United States

Other Identifiers

1906742940

Identifier Type: -

Identifier Source: org_study_id