An Interactive School Sleep Education Program

Sleep Clinical Trial

Official title:

An Interactive School Sleep Behavior Modification Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620240
• Other study ID #: Sleep Education
• Status: Completed
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: January 2019
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 in improving students' sleep behavior and corresponding outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 15 Years

Eligibility

Inclusion Criteria:

• Secondary school students

• Currently in year 2

Exclusion Criteria:

• Secondary school students form years other than year 2

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Sleep Education
Assessing the effectiveness of a Sleep Education Program in improving sleep behaviors in secondary school students.

Locations

Country	Name	City	State
Singapore	Duke-NUS Medical School	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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.	3 times (pre-program, immediately post-program and at 1-month follow-up)
Primary	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	3 times (pre-program, immediately post-program and at 1-month follow-up)
Primary	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.	3 times (pre-program, immediately post-program and at 1-month follow-up)