Daytime SleepinessNCT04176042
Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea
A study testing Track 1 and Track 2 in people with Daytime Sleepiness, run by University of Arizona at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Daytime Sleepiness
- What is being tested?
- Track 1 and Track 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Department of Psychiatry Research Facilities
Tucson, Arizona, 85724
About this study
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.
Read the 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
- Being tested
- Track 1, Track 2
- Keywords
- Daytime Sleepiness, Environmental Determinants, Sleep Beliefs, Sleep Attitudes, Educational Intervention, Focus Group, Epworth Sleepiness Scale
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Track 1Behavioural
Intervention + Follow-up
Track 2Behavioural
Wait list + Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Track 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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".
Measured: 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".
Measured: 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 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?
Measured: Focus Group [Day 0]
Demographics and Personal Information
This measure includes questions about age, sex, education level, relationship status, employment, status, and race/ethnicity.
Measured: 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
Measured: 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".
Measured: 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).
Measured: 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.
Measured: 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" .
Measured: 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.
Measured: 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".
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start18 Nov 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Daytime SleepinessStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Principal investigator, Michael A. Grandner, University of Arizona
- Investigators
- Michael A. Grandner, PhD, MTR, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176042
- Sponsor's protocol ID
- 1906742940
- Status last verified
- Dec 2020
- First submitted
- 8 Nov 2019
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea
- ClinicalTrials.gov ID
- NCT04176042
- Acronym / sponsor ID
- 1906742940
- Conditions
- Daytime Sleepiness
- Keywords
- Daytime Sleepiness, Environmental Determinants, Sleep Beliefs, Sleep Attitudes, Educational Intervention, Focus Group, Epworth Sleepiness Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Track 1 | Experimental | Behavioral: Track 1Subjects 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. |
| Track 2 | Active comparator | Behavioral: Track 2Subjects 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Track 1Intervention + Follow-up | Behavioural | Track 1 |
| Track 2Wait list + Intervention | Behavioural | Track 2 |
Primary outcome
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.
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.
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.
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.
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).
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).
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".
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".
9 secondary outcomes
Qualitative Themes in Sleep Beliefs (Discussed in a group setting)
Time frame: Focus Group [Day 0]
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A. Grandner, PhD, MTR principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Track 1 and Track 2 in people with Daytime Sleepiness, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.