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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05933746
Other study ID # IRB-21-10-4095
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date July 15, 2022

Study information

Verified date July 2023
Source Wayne State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date July 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: - Undergraduate students at Wayne State University - Self-reported desire to improve their sleep Exclusion Criteria: - Graduate students / professional students

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Hygiene Intervention
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.
Non-behavioral Sleep Education
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.

Locations

Country Name City State
United States Wayne State University Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep disturbance short-form b 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 Perceived Stress Scale 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
Secondary Sleep Hygiene Inventory 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
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