Mind-Body Interventions to Mitigate Effects of Media Use on Sleep (Sleepazoid Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime
研究概览
简要总结
Eliminating media use is neither feasible at a public health level nor perhaps even desirable given the role it plays in the lives of youth and adults, but mind-body interventions have the potential to mitigate state arousal effects and thus reduce negative impacts on sleep. Given emerging literature on links between intensive media use, sensory and interoceptive awareness, and self-regulation, this study will examine two related mind-body approaches -- a mindfulness sensory awareness exercises and mindful body awareness check-ins -- in a randomized clinical trial of early adolescents with evening media use and sleep problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child age at enrollment is 11y0m to 14y11m
- •Child is in the 6th-8th grade, or during summer recruitment, will be so in the coming autumn.
- •Total score of 52 or higher on the Sleep Disturbances Scale for Children (SDSC), a parent-report survey questionnaire regarding child sleep health
- •Parent reports child has >= 1 hour of media use during the 3 hours before bed at least 4 nights per week.
- •Parent and child both are comfortable reading and hearing instructions in English and in answering surveys written in English.
- •Families must also have at least two internet-connected portable screen devices available - one which much be an iOS or Android tablet or smartphone device and which will be used to download the games used in the media-induced arousal task and then used to play those games with the device in airplane mode, and a second which will be used to connect to the study staff via video conference, and which can be a laptop computer, tablet, or smartphone.
排除标准
- •Untreated diagnosis (by parent report) or positive screen for sleep-disordered breathing on the SDSC parent report survey questionnaire
- •Current use of medications known to affect sleep (systemic corticosteroids, stimulants, melatonin) by parent report
- •Sleeps at a second residence from enrolling parent more than two nights a week according to parent report
- •Has a current serious chronic medical condition known to affect sleep and/or arousal patterns (such as cancer or diabetes) by parent report.
- •Currently engages in meditation or body scan to fall asleep, according to parent report
- •We exclude potential participants who meet one of the following criteria because of concerns that their heart rate variability response may be too atypical to be valuable in this protocol (ASD or developmental delay, eating disorder, PTSD, illicit drug use) and/or because of concerns that the associated behavioral challenges and/or instability would impair ability to adhere to the entire 4-6 month protocol.
- •Diagnosis of Autism Spectrum Disorder or developmental delay by parent self-report
- •Current diagnosis of eating disorder by parent self-report
- •Current diagnosis of PTSD by parent self-report
- •Illicit drug use within the last three months by parent self-report
- •Is currently suicidal, based on the ASQ (Ask Suicide Screening Questions)
- •Hospitalization for depression or anxiety in the last year by parent self-report; or severe current depression symptoms as indicated by a t-score > 80 on the RCADS-
- •We will also exclude those with last year hospitalization, regardless of symptom score, because this is often an indicator of instability and undertreatment, and ability to adhere to the entire 4-6 month protocol would likely be impaired.
结局指标
主要结局
state arousal measured by heart rate variability (HRV), 30 minutes prior to usual bedtime
时间窗: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at 30 minutes prior to usual bedtime.
state arousal measured by heart rate variability (HRV), beginning at usual bedtime
时间窗: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning at usual bedtime.
state arousal measured by heart rate variability (HRV), when youth started trying to fall asleep
时间窗: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods on each of the two measurement nights beginning when the youth reported on the diary starting to try to fall asleep.
state arousal measured by heart rate variability (HRV), during game play exposure
时间窗: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods during the remote assessment visit during the last 5 minutes of the game play exposure.
state arousal measured by heart rate variability (HRV), during recovery period
时间窗: At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).
HRV will be captured by wireless telemetry (Empatica E4 and Actiheart), and primary metrics will be the pNN50 (the proportion of successive pairs of beat-to-beat intervals differing by more than 50ms in length) and the RMSSD (the root mean square of successive differences across successive pairs of beat-to-beat intervals). HRV will be compared between intervention and control and operationalized as the median of the statistic over 5-minute time periods during the remote assessment visit during the last 5 minutes of the recovery period post-exposure.
次要结局
- state arousal measured by electrodermal activity (EDA)(At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).)
- PreSleep Arousal Scale, modified for Children (PSAS-C), remote assessment visits(At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).)
- Adolescent Sleep Wake Scale (ASWS) total sleep scale score(At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).)
- mean sleep onset latency (SOL)(At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).)
- time to reach baseline arousal (HRV and EDA)(At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).)
- PreSleep Arousal Scale, modified for Children (PSAS-C), home measurement weeks(At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).)
- mean sleep duration(At baseline, and then at 8-12 weeks (directly after subjects complete intervention period A), and then at 16-20 weeks (directly after subjects complete intervention period B).)
研究者
Michelle Garrison
Investigator
Seattle Children's Hospital