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

Study Overview
=================
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.

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

Conditions
-----------------
Daytime Sleepiness

Intervention / Treatment
-----------------
* Behavioral: Track 1
* Behavioral: Track 2


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Track 1<br>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<br>* Intervention + Follow-up<br>|
| Active Comparator: Track 2<br>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<br>* Wait list + Intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Themes in Sleep Beliefs (Discussed in a group setting) | 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? | Focus Group [Day 0] | 
| Demographics and Personal Information | This measure includes questions about age, sex, education level, relationship status, employment, status, and race/ethnicity. | 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 | Self-report questions about medical history, including family 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) | 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. | 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) | 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). | 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) | ISI is a brief (7-item) insomnia screening tool that is the gold standard for quantifying severity of clinical insomnia symptoms. | 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 | 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 . | 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) | 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. | 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) | 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. | 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Daytime Sleepiness, Environmental Determinants, Sleep Beliefs, Sleep Attitudes, Educational Intervention, Focus Group, Epworth Sleepiness Scale