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临床试验/NCT03620240
NCT03620240已完成不适用

An Interactive School Sleep Behavior Modification Program

Duke-NUS Graduate Medical School1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2018年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
205
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
13 Years 至 15 Years(Child)
性别
Male
接受健康志愿者
是

入选标准

  • •Secondary school students
  • •Currently in year 2

排除标准

  • •Secondary school students form years other than year 2

研究组 & 干预措施

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.

干预措施: Sleep Education (Behavioral)

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.

结局指标

主要结局

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.

时间窗: 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 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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 3 times (pre-program, immediately post-program and at 1-month follow-up)

Amount of time spent on each activity

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.

时间窗: 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

Relationship between sleep and time use.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Duke-NUS Graduate Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael WL Chee, MBBS

Principle Investigator, Professor

Duke-NUS Graduate Medical School

研究点 (1)

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