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Completed

NCT Number: NCT04176042

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

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.

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Key information

Conditions

Daytime Sleepiness Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Department of Psychiatry Research Facilities

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Track 1

Behavioral

Intervention + Follow-up

Track 2

Behavioral

Wait list + Intervention

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 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).

  7. Changes in Dysfunctional Beliefs About Sleep Scale score for Track 1

    Time frame: 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".

  8. Changes in Dysfunctional Beliefs About Sleep Scale score for Track 2

    Time frame: 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".

Secondary outcomes

  1. Qualitative Themes in Sleep Beliefs (Discussed in a group setting)

    Time frame: Focus Group [Day 0]

    Focus Group to gather qualitative themes guided by the following questions:

    • What is healthy sleep?
    • What is unhealthy sleep?
    • What is sleepiness?
    • How does sleepiness affect you?
    • What is the most important thing about your sleepiness?
    • What do you do about your sleepiness?

  2. Demographics and Personal Information

    Time frame: 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).

    This measure includes questions about age, sex, education level, relationship status, employment, status, and race/ethnicity.

  3. Medical History

    Time frame: 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).

    Self-report questions about medical history, including family medical history

  4. Fatigue Severity Scale (FSS)

    Time frame: 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).

    FSS is a well-validated 9-item clinical measure that assesses overall levels of mental and physical fatigue, with answers ranging from 1- "Strongly Disagree" to 7-"Strongly Agree".

  5. Sleep Timing Questionnaire (STQ)

    Time frame: 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).

    STQ assesses weekday and weekend sleep timing and sleep duration, as well as variability in sleep timing, with responses in the form of # of minutes (i.e. 25 minutes) or hourly times (i.e. 7:00 pm).

  6. Insomnia Severity Index (ISI)

    Time frame: 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).

    ISI is a brief (7-item) insomnia screening tool that is the gold standard for quantifying severity of clinical insomnia symptoms.

  7. Sleep Disorders Symptom Check List

    Time frame: 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).

    a 20 question instrument was developed to screen for six sleep disorders (insomnia, obstructive sleep apnea, restless legs syndrome/periodic limb movement disorder, circadian rhythm sleep-wake disorders, narcolepsy, and parasomnias) and evaluated psychometrically. Answers range from "Never" to ">5 times a week" .

  8. Patient Health Questionnaire (PHQ9)

    Time frame: 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).

    The PHQ9 will screen for depression symptoms. It is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: It incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Participants with a score >9 will be excluded. A total score is calculated for this tool.

  9. Generalized Anxiety Disorder 7- Item Scale (GAD-7)

    Time frame: 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).

    is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. It contains 7 items with answers ranging from "Not at all" to "Nearly every day".

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Jazz Pharmaceuticals

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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