Sleep HabitsNCT02491138
An Evaluation of Appearance-based Interventions for the Promotion of Sleep
A study testing Appearance-based intervention and Pamphlets in people with Sleep Habits and Healthy, run by Yale-NUS College at 1 site in Singapore.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Habits, Healthy
- What is being tested?
- Appearance-based intervention and Pamphlets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2015to Dec 2016
- 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 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-24 years
- <7 hours of sleep routinely
Who cannot join
- per-existing medical, sleep, or psychiatric conditions;
- history of substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Sleep Habits, Healthy
- Being tested
- Appearance-based intervention, Pamphlets
- Keywords
- participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appearance-based interventionBehavioural
PamphletsOther
| Study group | Role | What they receive |
|---|---|---|
| Standard information | Placebo comparator | In this arm, participants will receive standard information pamphlets about the benefits of good sleeping habits. Receives: Other: Pamphlets |
| Appearance-based information | Experimental | 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. Receives: Behavioral: Appearance-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective sleep duration
Measured through actigraphy
Measured: Up to 1 month after the intervention
Self-reported sleep hygiene
Measured through the Sleep Hygiene scale (total score: higher score corresponds to poorer sleep hygiene)
Measured: Up to 1 month after the intervention
Secondary outcomes (2)
Subjective sleep quality
Measured through the Pittsburgh Sleep Quality Index (global score: higher score corresponds to poorer sleep quality)
Measured: Up to 1 month
Insomnia-related cognition
Measured through the Dysfunctional Beliefs and Attitudes about Sleep scale (total score: higher score corresponds to more dysfunctional beliefs and attitudes)
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep HabitsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS College, University of St Andrews
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491138
- Sponsor's protocol ID
- A-15-083
- Status last verified
- Jul 2017
- First submitted
- 2 Jul 2015
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perucho I, Vijayakumar KM, Talamas SN, Chee MW, Perrett DI, Liu JCJ. A Web-Based Photo-Alteration Intervention to Promote Sleep: Randomized Controlled Trial. J Med Internet Res. 2019 Sep 26;21(9):e12500. doi: 10.2196/12500.
PubMed 31573913
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Appearance-based Interventions for the Promotion of Sleep
- ClinicalTrials.gov ID
- NCT02491138
- Acronym / sponsor ID
- A-15-083
- Conditions
- Sleep Habits, Healthy
- Keywords
- participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Collaborators
- Duke-NUS College, University of St Andrews
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Jul 2015 (estimated)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard information | Placebo comparator | Other: PamphletsIn this arm, participants will receive standard information pamphlets about the benefits of good sleeping habits. |
| Appearance-based information | Experimental | Behavioral: Appearance-based interventionIn 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-24 years
- <7 hours of sleep routinely
Key exclusion criteria (2 listed)
- per-existing medical, sleep, or psychiatric conditions;
- history of substance abuse.
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 |
|---|---|---|
| Appearance-based intervention | Behavioural | Appearance-based information |
| Pamphlets | Other | Standard information |
Primary outcome
Objective sleep duration
Time frame: Up to 1 month after the intervention
Measured through actigraphy
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)
2 secondary outcomes
Subjective sleep quality
Time frame: Up to 1 month
Insomnia-related cognition
Time frame: Up to 1 month
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 5 Oct 2018.
- Derived from this study: PubMed 31573913Perucho I, Vijayakumar KM, Talamas SN, Chee MW, Perrett DI, Liu JCJ. A Web-Based Photo-Alteration Intervention to Promote Sleep: Randomized Controlled Trial. J Med Internet Res. 2019 Sep 26;21(9):e12500. doi: 10.2196/12500.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appearance-based intervention and Pamphlets in people with Sleep Habits and Healthy, run by Yale-NUS College at 1 site in Singapore.
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 2 inclusion and 2 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 5 Oct 2018. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Objective sleep duration (time frame: Up to 1 month after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02491138, which also lists 1 linked publication.
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 5 Oct 2018.