- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02491138
An Evaluation of Appearance-based Interventions for the Promotion of Sleep
October 3, 2018 updated by: Yale-NUS College
This study evaluates the efficacy of appearance-based interventions in promoting healthy sleep.
One group of participants will receive standard information about sleep (control group), while the other group will receive information about how sleep affects their physical appearance (intervention group).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
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
-
-
-
Singapore, Singapore, 138527
- Yale-NUS College
-
-
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
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-24 years
- <7 hours of sleep routinely
Exclusion Criteria:
- per-existing medical, sleep, or psychiatric conditions;
- history of substance abuse.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Standard information
In this arm, participants will receive standard information pamphlets about the benefits of good sleeping habits.
|
|
|
Experimental: Appearance-based information
In this arm, participants will receive information about how sleep modifies their physical appearance.
This will involve a computer transformation that morphs their face according to hours of sleep obtained.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective sleep duration
Time Frame: Up to 1 month after the intervention
|
Measured through actigraphy
|
Up to 1 month after the intervention
|
|
Self-reported sleep hygiene
Time Frame: Up to 1 month after the intervention
|
Measured through the Sleep Hygiene scale (total score: higher score corresponds to poorer sleep hygiene)
|
Up to 1 month after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective sleep quality
Time Frame: Up to 1 month
|
Measured through the Pittsburgh Sleep Quality Index (global score: higher score corresponds to poorer sleep quality)
|
Up to 1 month
|
|
Insomnia-related cognition
Time Frame: Up to 1 month
|
Measured through the Dysfunctional Beliefs and Attitudes about Sleep scale (total score: higher score corresponds to more dysfunctional beliefs and attitudes)
|
Up to 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
July 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
July 2, 2015
First Submitted That Met QC Criteria
July 6, 2015
First Posted (Estimate)
July 7, 2015
Study Record Updates
Last Update Posted (Actual)
October 5, 2018
Last Update Submitted That Met QC Criteria
October 3, 2018
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A-15-083
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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