Department of Medicine, University of Otago, Dunedin, New Zealand.
Haszard Biostatistics, Dunedin, New Zealand.
JMIR Res Protoc. 2024 Aug 20;13:e63692. doi: 10.2196/63692.
It is recommended that children should avoid eating dinner, being physically active, or using screens in the hour before bed to ensure good sleep health. However, the evidence base behind these guidelines is weak and limited to cross-sectional studies using questionnaires.
The aim of this randomized crossover trial was to use objective measures to experimentally determine whether recommendations to improve sleep by banning electronic media, physical activity, or food intake in the hour before bed, impact sleep quantity and quality in the youth.
After a baseline week to assess usual behavior, 72 children (10-14.9 years old) will be randomized to four conditions, which are (1) avoid all 3 behaviors, (2) use screens for at least 30 minutes, (3) be physically active for at least 30 minutes, and (4) eat a large meal, during the hour before bed on days 5 to 7 of weeks 2 to 5. Families can choose which days of the week they undertake the intervention, but they must be the same days for each intervention week. Guidance on how to undertake each intervention will be provided. Interventions will only be undertaken during the school term to avoid known changes in sleep during school holidays. Intervention adherence and shuteye latency (time from getting into bed until attempting sleep) will be measured by wearable and stationary PatrolEyes video cameras (StuntCams). Sleep (total sleep time, sleep onset, and wake after sleep onset) will be measured using actigraphy (baseline, days 5 to 7 of each intervention week). Mixed effects regression models with a random effect for participants will be used to estimate mean differences (95% CI) for conditions 2 to 4 compared with condition 1.
Recruitment started in March 2024, and is anticipated to finish in April 2025. Following data analysis, we expect that results will be available later in 2026.
Using objective measures, we will be able to establish if causal relationships exist between prebedtime behaviors and sleep in children. Such information is critical to ensure appropriate and achievable sleep guidelines.
Australian New Zealand Clinical Trials Registry ACTRN12624000206527; https://tinyurl.com/3kcjmfnj.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63692.
建议儿童在睡前一小时避免用餐、进行体育活动或使用电子屏幕,以确保良好的睡眠健康。然而,这些指导方针的证据基础薄弱,仅限于使用问卷进行的横断面研究。
本随机交叉试验旨在使用客观测量方法,实验确定睡前一小时禁止电子媒体、体育活动或饮食摄入等建议是否会影响青少年的睡眠数量和质量。
在基线周评估常规行为后,72 名(10-14.9 岁)儿童将被随机分为 4 组,分别为(1)避免所有 3 种行为,(2)至少使用电子屏幕 30 分钟,(3)至少进行 30 分钟体育活动,以及(4)在第 2 至第 5 周的第 5 至 7 天的睡前一小时内吃大餐。家庭可以选择在一周中的哪几天进行干预,但必须在每个干预周的相同几天进行。将提供有关如何进行每项干预的指导。仅在学期内进行干预,以避免学校假期期间睡眠已知的变化。穿戴式和固定式 PatrolEyes 摄像机(StuntCams)将测量干预期间的干预依从性和入睡潜伏期(从上床到尝试入睡的时间)。使用活动记录仪(基线,每个干预周的第 5 至 7 天)测量睡眠(总睡眠时间、入睡时间和睡眠后醒来时间)。将使用具有参与者随机效应的混合效应回归模型来估计条件 2 至 4 与条件 1 相比的平均差异(95%CI)。
招募于 2024 年 3 月开始,预计于 2025 年 4 月完成。数据分析后,我们预计结果将在 2026 年晚些时候公布。
使用客观测量方法,我们将能够确定儿童睡前行为与睡眠之间是否存在因果关系。此类信息对于确保适当和可实现的睡眠指南至关重要。
澳大利亚和新西兰临床试验注册 ACTRN12624000206527;https://tinyurl.com/3kcjmfnj。
国际注册报告标识符(IRRID):DERR1-10.2196/63692。