SleepNCT03620240
An Interactive School Sleep Education Program
A study testing Sleep Education in people with Sleep, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
The aim of this study is to improve sleep behavior in secondary school students, through the use of an educational program specifically designed for this purpose. Data will be collected on students' time use, sleep habits, daytime functioning and mood before and after the program to assess if the program is effective… Read more about this study
- Who is it for?
- Ages 13 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Jul 2018to 1 Oct 2018
- 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 13 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Secondary school students
- Currently in year 2
Who cannot join
- Secondary school students form years other than year 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interactive School Sleep Behavior Modification Program
The aim of this study is to improve sleep behavior in secondary school students, through the use of an educational program specifically designed for this purpose. Data will be collected on students' time use, sleep habits, daytime functioning and mood before and after the program to assess if the program is effective in improving students' sleep behavior and corresponding outcomes.
Read the detailed description
The present study aims to examine the effectiveness of a class-based interactive Sleep Education Program in improving sleep behavior of secondary school students. The Sleep Education Program is designed by sleep experts from our laboratory, and is aimed at educating students about the importance of sleep and good sleep habits, as well as addressing their attitudes towards sleep, in order to encourage behavior change. Participants will be randomly assigned to the Sleep Education Program or a Control Program. All participants will undergo four weekly class-based lessons, which use video presentations, in-class activities, discussions and take-home assignments to deliver the materials. Each lesson has set goals to achieve. Participants in the Sleep Education Program will learn about the importance of sleep, what factors may prevent them from getting enough sleep, how they can manage their time to create more opportunity for sleep, and how they can overcome obstacles to time management. Emphasis will be placed on how sleep affects each student personally, and how each person can benefit from improving sleep. Participants in the Control Program will undergo a similarly structured class-based program, during which they will learn about various general health-related topics. However, the Control Program is designed in such a way that it does not cover any topics related to sleep. Data will be collected from participants from both groups. The following variables are measured: sleep habits, sleep knowledge, daytime functioning, mood and app-tracked time use. Data on all measurements will be collected at three time points: pre-program, immediately post-program and during a 1-month follow-up. Results will be compared between the three time points, as well as between the two groups (Sleep Education Program and Control Program). By comparing results from the Sleep Education Program to the Control Program, we can evaluate the effect of educating students about sleep on improving sleep behavior.
- Conditions
- Sleep
- Being tested
- Sleep Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep EducationBehavioural
Assessing the effectiveness of a Sleep Education Program in improving sleep behaviors in secondary school students.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Education | Experimental | Half of the participants are randomly assigned to the Sleep Education group. These participants will undergo 4 weekly class-based lesson, during which they are educated about sleep. Receives: Behavioral: Sleep Education |
| Control | No intervention | Half of the participants are randomly assigned to the Control group. These participants undergo 4 weekly class-based lessons, during which they are educated about health-related topics, but not about sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in actigraphically measured sleep behavior between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured for one week in each of the three phases.
Bedtime, wake up time, time in bed, total sleep time, sleep efficiency, timing and duration of daytime naps
Measured: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Change in sleep dairy reported sleep behavior between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), recorded for one week in each of the three phases.
Bedtime, wake up time, total sleep time, sleep efficiency, number and duration of nighttime awakenings, number and duration of daytime naps
Measured: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Change in the level of subjective mood between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured once daily with a Mood Rating Scale over the period of one week.
Score on the Mood Rating Scale. Range: 1 (extremely bad) to 9 (extremely good). Higher values represent a better outcome.
Measured: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Change in the level of subjective sleepiness between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured once daily with the Karolinska Sleepiness Scale over the period of one week.
Score on the Karolinska Sleepiness Scale. Range: 1 (extremely alert) to 9 (extremely sleep, fighting sleep). Lower values represent a better outcome.
Measured: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Change in sleep knowledge between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured with a sleep knowledge questionnaire.
Score on the sleep knowledge questionnaire. Range: 0 (all incorrect answers) to 12 (all correct answers). Higher values represent a better outcome.
Measured: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Change in time use between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured daily with a time use diary over the period of one week.
Amount of time spent on each activity
Measured: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Relationship between sleep and time use.
Amount of time spent on each activity, measured with a time use diary, correlated with sleep variables, measured with actigraphy and a sleep diary.
Measured: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start3 Jul 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael WL Chee, MBBS, Duke-NUS Graduate Medical School
- Investigators
- Michael WL Chee, MBBS, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620240
- Sponsor's protocol ID
- Sleep Education
- Status last verified
- Jan 2019
- First submitted
- 24 Jul 2018
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Rijn E, Koh SYJ, Ng ASC, Vinogradova K, Chee NIYN, Lee SM, Lo JC, Gooley JJ, Chee MWL. Evaluation of an interactive school-based sleep education program: a cluster-randomized controlled trial. Sleep Health. 2020 Apr;6(2):137-144. doi: 10.1016/j.sleh.2019.10.006. Epub 2019 Dec 4.
PubMed 31812609
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive School Sleep Behavior Modification Program
- ClinicalTrials.gov ID
- NCT03620240
- Acronym / sponsor ID
- Sleep Education
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 8 Aug 2018 (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 aim of this study is to improve sleep behavior in secondary school students, through the use of an educational program specifically designed for this purpose. Data will be collected on students' time use, sleep habits, daytime functioning and mood before and after the program to assess if the program is effective in improving students' sleep behavior and corresponding outcomes.
Detailed description
The present study aims to examine the effectiveness of a class-based interactive Sleep Education Program in improving sleep behavior of secondary school students. The Sleep Education Program is designed by sleep experts from our laboratory, and is aimed at educating students about the importance of sleep and good sleep habits, as well as addressing their attitudes towards sleep, in order to encourage behavior change. Participants will be randomly assigned to the Sleep Education Program or a Control Program. All participants will undergo four weekly class-based lessons, which use video presentations, in-class activities, discussions and take-home assignments to deliver the materials. Each lesson has set goals to achieve. Participants in the Sleep Education Program will learn about the importance of sleep, what factors may prevent them from getting enough sleep, how they can manage their time to create more opportunity for sleep, and how they can overcome obstacles to time management. Emphasis will be placed on how sleep affects each student personally, and how each person can benefit from improving sleep. Participants in the Control Program will undergo a similarly structured class-based program, during which they will learn about various general health-related topics. However, the Control Program is designed in such a way that it does not cover any topics related to sleep. Data will be collected from participants from both groups. The following variables are measured: sleep habits, sleep knowledge, daytime functioning, mood and app-tracked time use. Data on all measurements will be collected at three time points: pre-program, immediately post-program and during a 1-month follow-up. Results will be compared between the three time points, as well as between the two groups (Sleep Education Program and Control Program). By comparing results from the Sleep Education Program to the Control Program, we can evaluate the effect of educating students about sleep on improving sleep behavior.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Education | Experimental | Behavioral: Sleep EducationHalf of the participants are randomly assigned to the Sleep Education group. These participants will undergo 4 weekly class-based lesson, during which they are educated about sleep. |
| Control | No intervention | –Half of the participants are randomly assigned to the Control group. These participants undergo 4 weekly class-based lessons, during which they are educated about health-related topics, but not about sleep. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Secondary school students
- Currently in year 2
Key exclusion criteria (1 listed)
- Secondary school students form years other than year 2
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 |
|---|---|---|
| Sleep EducationAssessing the effectiveness of a Sleep Education Program in improving sleep behaviors in secondary school students. | Behavioural | Sleep Education |
Primary outcome
Change in actigraphically measured sleep behavior between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured for one week in each of the three phases.
Time frame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Bedtime, wake up time, time in bed, total sleep time, sleep efficiency, timing and duration of daytime naps
Change in sleep dairy reported sleep behavior between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), recorded for one week in each of the three phases.
Time frame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Bedtime, wake up time, total sleep time, sleep efficiency, number and duration of nighttime awakenings, number and duration of daytime naps
Change in the level of subjective mood between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured once daily with a Mood Rating Scale over the period of one week.
Time frame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Score on the Mood Rating Scale. Range: 1 (extremely bad) to 9 (extremely good). Higher values represent a better outcome.
Change in the level of subjective sleepiness between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured once daily with the Karolinska Sleepiness Scale over the period of one week.
Time frame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Score on the Karolinska Sleepiness Scale. Range: 1 (extremely alert) to 9 (extremely sleep, fighting sleep). Lower values represent a better outcome.
Change in sleep knowledge between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured with a sleep knowledge questionnaire.
Time frame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Score on the sleep knowledge questionnaire. Range: 0 (all incorrect answers) to 12 (all correct answers). Higher values represent a better outcome.
Change in time use between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured daily with a time use diary over the period of one week.
Time frame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Amount of time spent on each activity
Relationship between sleep and time use.
Time frame: 3 times (pre-program, immediately post-program and at 1-month follow-up)
Amount of time spent on each activity, measured with a time use diary, correlated with sleep variables, measured with actigraphy and a sleep diary.
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 14 Jan 2019.
- Derived from this study: PubMed 31812609van Rijn E, Koh SYJ, Ng ASC, Vinogradova K, Chee NIYN, Lee SM, Lo JC, Gooley JJ, Chee MWL. Evaluation of an interactive school-based sleep education program: a cluster-randomized controlled trial. Sleep Health. 2020 Apr;6(2):137-144. doi: 10.1016/j.sleh.2019.10.006. Epub 2019 Dec 4.
- Individual participant dataSharing planned: No
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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.
Michael WL Chee, MBBS principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Education in people with Sleep, run by Duke-NUS Graduate Medical School 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 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 14 Jan 2019. 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. 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?
Change in actigraphically measured sleep behavior between time 1 (pre-program), time 2 (immediately post-program) and time 3 (at 1-month follow-up), measured for one week in each of the three phases. (time frame: 3 times (pre-program, immediately post-program and at 1-month follow-up)). The study lists 7 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 NCT03620240, 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 14 Jan 2019.