SleepNCT04035213
Sleep, the Never-ending Quest of College Students
A study testing Behavior of Sleep Course in people with Sleep and Sleep Disturbance, run by University of Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether undergraduate students completing a course focused entirely on sleep at a major urban university evidence positive changes in their sleep patterns compared to students completing a similar-level course (without any discussion of sleep) in the same department… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Disturbance, Sleep Hygiene
- What is being tested?
- Behavior of Sleep Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 1 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All undergraduate students at UH age 18 and older who are enrolled in the following upper-level courses and who provide consent to participate will be eligible to participate as control participants
Who cannot join
- Previous enrollment in PSYC 4397: The Behavior of Sleep course or a similar course.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep, the Never-ending Quest of College Students: Effects of a Semester Long Sleep Course on Sleep Patterns and Daytime Functioning
The purpose of this study is to evaluate whether undergraduate students completing a course focused entirely on sleep at a major urban university evidence positive changes in their sleep patterns compared to students completing a similar-level course (without any discussion of sleep) in the same department (Psychology) at the same university (UH). Potential changes in sleep patterns across the semester will be examined as well as whether putative changes in sleep can be linked with academic and mental health outcomes.
Read the detailed description
Aim 1) To evaluate whether a semester long course focused entirely on sleep produces improvements in college students' sleep patterns across the semester based on one-week sleep diaries.
H1: Compared to students enrolled in other courses who are not expected to show significant changes in sleep patterns, students enrolled in the sleep course will demonstrate increases in total sleep time, decreases in sleep onset latency, and decreases in nighttime awakenings. In line with Mayer's theoretical model, these sleep-based changes will evidence non-linear (i.e., quadractic) patterns across four time points during the semester.
Aim 2) To evaluate changes in sleep hygiene behaviors across the semester among students enrolled in a sleep course compared to students enrolled in other courses.
H2: Compared to students enrolled in other courses who are not expected to show significant changes in sleep hygiene behaviors, students enrolled in the sleep course will report a decreased frequency of naps, use of electronics within one hour of bed, and an increase in sleep regularity (e.g., reduction in the discrepancy between weekend and weekday wake times) across the four time points during the semester.
Aim 3) To evaluate how sleep patterns relate to daytime mood and energy levels across the semester among students enrolled in a sleep course and other courses.
H3: Greater total sleep time, shorter sleep onset latency, fewer nighttime awakenings, a less discrepancy between weekend and weekday wake times will predict higher energy levels and mood among both groups across the semester.
Aim 4) To evaluate how sleep patterns across the semester predict final course grades among students enrolled in a sleep course.
H4: Students enrolled in the sleep course who demonstrate increases in total sleep time, decreases in sleep onset latency, and decreases in nighttime awakenings across the semester will achieve higher final course grades than students who demonstrate minimal to no improvements in sleep.
- Conditions
- Sleep, Sleep Disturbance, Sleep Hygiene
- Being tested
- Behavior of Sleep Course
- Medical subject headings
- Parasomnias, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior of Sleep CourseBehavioural
The current study will evaluate whether a semester-long course focused on sleep improves college students' sleep patterns over one semester compared to students completing a similar-level course in the same department (Psychology) at the same university.
| Study group | Role | What they receive |
|---|---|---|
| Behavior of Sleep Course | Experimental | A semester-long course focused on sleep improves college students' sleep patterns over one semester. The listed aims of this course are to: 1) provide students with a comprehensive understanding of sleep; 2) afford an overview of the multiple ways sleep impact health, performance and well-being; and 3) to assist students in discovering how their own sleep-wake patterns impact their day to day functioning. Receives: Behavioral: Behavior of Sleep Course |
| Control | No intervention | Students from other upper level departmental courses with content that does not include a focus on or discussion of sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Sleep Foundation Sleep Diary
The National Sleep Foundation Sleep Diary is a self-report diary designed to help participants track their sleep, sleep habits, and other relevant sleep behaviors (e.g., caffeine use) over a seven-day period.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start19 Aug 2019
- Primary completion1 Dec 2021
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Lau, University of Houston
- Investigators
- Simon Lau, M.A., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035213
- Sponsor's protocol ID
- STUDY00001775
- Status last verified
- Nov 2023
- First submitted
- 24 Jul 2019
- Last updated
- 28 Nov 2023
- Results posted
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, the Never-ending Quest of College Students: Effects of a Semester Long Sleep Course on Sleep Patterns and Daytime Functioning
- ClinicalTrials.gov ID
- NCT04035213
- Acronym / sponsor ID
- STUDY00001775
- Conditions
- Sleep, Sleep Disturbance, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 29 Jul 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 evaluate whether undergraduate students completing a course focused entirely on sleep at a major urban university evidence positive changes in their sleep patterns compared to students completing a similar-level course (without any discussion of sleep) in the same department (Psychology) at the same university (UH). Potential changes in sleep patterns across the semester will be examined as well as whether putative changes in sleep can be linked with academic and mental health outcomes.
Detailed description
Aim 1) To evaluate whether a semester long course focused entirely on sleep produces improvements in college students' sleep patterns across the semester based on one-week sleep diaries.
H1: Compared to students enrolled in other courses who are not expected to show significant changes in sleep patterns, students enrolled in the sleep course will demonstrate increases in total sleep time, decreases in sleep onset latency, and decreases in nighttime awakenings. In line with Mayer's theoretical model, these sleep-based changes will evidence non-linear (i.e., quadractic) patterns across four time points during the semester.
Aim 2) To evaluate changes in sleep hygiene behaviors across the semester among students enrolled in a sleep course compared to students enrolled in other courses.
H2: Compared to students enrolled in other courses who are not expected to show significant changes in sleep hygiene behaviors, students enrolled in the sleep course will report a decreased frequency of naps, use of electronics within one hour of bed, and an increase in sleep regularity (e.g., reduction in the discrepancy between weekend and weekday wake times) across the four time points during the semester.
Aim 3) To evaluate how sleep patterns relate to daytime mood and energy levels across the semester among students enrolled in a sleep course and other courses.
H3: Greater total sleep time, shorter sleep onset latency, fewer nighttime awakenings, a less discrepancy between weekend and weekday wake times will predict higher energy levels and mood among both groups across the semester.
Aim 4) To evaluate how sleep patterns across the semester predict final course grades among students enrolled in a sleep course.
H4: Students enrolled in the sleep course who demonstrate increases in total sleep time, decreases in sleep onset latency, and decreases in nighttime awakenings across the semester will achieve higher final course grades than students who demonstrate minimal to no improvements in sleep.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavior of Sleep Course | Experimental | Behavioral: Behavior of Sleep CourseA semester-long course focused on sleep improves college students' sleep patterns over one semester. The listed aims of this course are to: 1) provide students with a comprehensive understanding of sleep; 2) afford an overview of the multiple ways sleep impact health, performance and well-being; and 3) to assist students in discovering how their own sleep-wake patterns impact their day to day functioning. |
| Control | No intervention | –Students from other upper level departmental courses with content that does not include a focus on or discussion of sleep |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All undergraduate students at UH age 18 and older who are enrolled in the following upper-level courses and who provide consent to participate will be eligible to participate as control participants
Key exclusion criteria (1 listed)
- Previous enrollment in PSYC 4397: The Behavior of Sleep course or a similar course.
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 |
|---|---|---|
| Behavior of Sleep CourseThe current study will evaluate whether a semester-long course focused on sleep improves college students' sleep patterns over one semester compared to students completing a similar-level course in the same department (Psychology) at the same university. | Behavioural | Behavior of Sleep Course |
Primary outcome
National Sleep Foundation Sleep Diary
Time frame: 7 days
The National Sleep Foundation Sleep Diary is a self-report diary designed to help participants track their sleep, sleep habits, and other relevant sleep behaviors (e.g., caffeine use) over a seven-day period.
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 28 Nov 2023.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Simon Lau, M.A. principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior of Sleep Course in people with Sleep and Sleep Disturbance, run by University of Houston 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 1 inclusion and 1 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 28 Nov 2023. 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?
National Sleep Foundation Sleep Diary (time frame: 7 days). 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 28 Nov 2023.