- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05933746
Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress
July 6, 2023 updated by: Mark A. Lumley, Wayne State University
The Impact of a Remote, Brief, Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress: A Randomized, Controlled Trial
Poor sleep is common among college students and likely contributes to stress.
The investigators developed a brief, remotely-delivered intervention and tested whether it improves sleep hygiene and reduced sleep disturbance and stress among undergraduates.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Poor sleep is common among college students and likely contributes to stress.
The investigators developed a brief, remotely-delivered sleep hygiene intervention, which is delivered via the internet, and tested in a randomized controlled trial, whether it improves sleep hygiene and reduced sleep disturbance and stress in a sample of undergraduates who report wanting to improve their sleep.
This study compares the novel sleep hygiene intervention to an active, matched control condition--sleep education.
Baseline and 2-week follow-up questionnaires assess sleep hygiene, sleep disturbance, and stress.
ANCOVAs will compare conditions at follow-up, and mediation tests will explore whether the intervention reduced stress through improved sleep.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Wayne State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Undergraduate students at Wayne State University
- Self-reported desire to improve their sleep
Exclusion Criteria:
- Graduate students / professional students
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep Hygiene Intervention
1-hour, on-line set of three modules pertaining to various sleep hygiene behaviors
|
This 1-hour on-line intervention presents three sleep hygiene modules, selected randomly from among these six: establishing a bedtime routine, optimizing sleep environment, implementing a sleep schedule, bedtime relaxation, nutrition choices, and exercise habits.
|
Placebo Comparator: Non-behavioral Sleep Education
active, matched placebo condition that controls for engagement and rationale
|
1-hour on-line set of three modules that cover non-skill (non-hygiene) educational topics (sleep research, sleep stages, dreams).
This control condition equates for engagement rationale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep disturbance short-form b
Time Frame: Change from baseline to 2-week follow-up
|
8-item measure assesses sleep disturbances over last 7 days (range: 8 to 40; higher scores = more sleep disturbance)
|
Change from baseline to 2-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale
Time Frame: Change from baseline to 2-week follow-up
|
10-item measure of perceived stress over past 7 days (range 0 to 40; higher scores = more perceived stress)
|
Change from baseline to 2-week follow-up
|
Sleep Hygiene Inventory
Time Frame: Change from baseline to 2-week follow-up
|
13-item measure of maladaptive sleep hygiene behaviors over last 7 days (range: 13-65; higher scores = worse hygiene)
|
Change from baseline to 2-week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
July 15, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
June 27, 2023
First Submitted That Met QC Criteria
June 27, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
July 10, 2023
Last Update Submitted That Met QC Criteria
July 6, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-21-10-4095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Data set, upon reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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