An Interactive School Sleep Education Program | NCT03620240

NCT03620240

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleep Education	Behavioral	Assessing the effectiveness of a Sleep Education Program in improving sleep behaviors in secondary school students.	Sleep Education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	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.	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.	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.

Eligibility Module

Name	Affiliation	Role
Michael WL Chee, MBBS	Duke-NUS Graduate Medical School	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duke-NUS Medical School		Singapore		169857	Singapore

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31812609	Derived	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.