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

NCT04176042 | Completed

• 1 other identifier: 1906742940
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Daytime Sleepiness

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Change of Epworth Sleepiness Scale (ESS) score across specific time points for Track 1

  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 from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks).

• Change of Epworth Sleepiness Scale (ESS) score across specific time points for Track 2

  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 from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).

• Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 1

  This questionnaire assesses habitual sleep behaviors associated with sleep and potential sleep problems.

  Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)

• Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 2

  This questionnaire assesses habitual sleep behaviors associated with sleep and potential sleep problems.

  Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)

• Changes in Sleep Beliefs Scale (SBS) score for Track 1

  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 from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)

• Changes in Sleep Beliefs Scale (SBS) score for Track 2

  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 from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)

• Changes in Dysfunctional Beliefs About Sleep Scale score for Track 1

  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 from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)

• Changes in Dysfunctional Beliefs About Sleep Scale score for Track 2

  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 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 (9)

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

Track 1

EXPERIMENTAL

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.

Behavioral: Track 1

Track 2

ACTIVE COMPARATOR

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.

Behavioral: Track 2

Interventions

Track 1 BEHAVIORAL

Intervention + Follow-up

Track 1

Track 2 BEHAVIORAL

Wait list + Intervention

Track 2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

University of Arizona Department of Psychiatry Research Facilities

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Michael A. Grandner, PhD, MTR

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All 28 participants will be randomized to one of two 4-week tracks (N=14 each).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Psychology, and Medicine; Director, Sleep & Health Research Program, University of Arizona

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 25, 2019
• Study Start: November 18, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)