Harnessing Sleep/Circadian Rhythm Data as a Biomarker to Mitigate Health Risks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Psychiatric Health - Internalizing and Externalizing Symptoms of Childhood
研究概览
简要总结
The overall goal of this study is to investigate associations between sleep/circadian disturbances and psychiatric health among adolescents recruited from primary and specialty health clinics.
详细描述
This project will involve recruitment of 100 adolescents from primary and specialty health clinics. Participants will participate in 3 phases: screening/intake visit, sleep study, and follow-up visit.
The 1-hour screening/intake visit will be conducted at the Duke ADHD clinic at 2608 Erwin Road, Pavilion East, Suite 300, Durham, NC 27705. During the screening/intake visit, participants and their parents will complete questionnaires regarding the adolescent's psychiatric health. Participants' vitals (i.e., height, weight, resting heart rate, blood pressure) will also be assessed and recorded.
Eligible participants will enter the 7-day sleep study, during which they will be asked to wear an actigraph watch 24 hours/day, apply a EEG sleep recorder each night, and complete a daily sleep diary.
Following the final night of the sleep study, participants and parents will be asked to return for a follow-up visit and will complete questionnaires about the participants' sleep over the past week.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Between the ages of 11 years 0 months to 17 years 11 months (inclusive), at the time of parental informed consent.
- •Ability to follow written and verbal instructions (English), as assessed by the PI and/or study coordinator.
- •Ability to comply with all testing, requirements, study procedures, and availability for the duration of the study.
排除标准
- •Participants who have a diagnosis of occult sleep disorders (i.e., sleep apnea, periodic leg movement syndrome)
- •Participants who currently use prescribed or over-the-counter sleep aids (i.e., melatonin)
- •Participants who have acute or chronic medical illnesses or medications that may interfere with sleep as determined by the research team.
- •Unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the principal investigator.
结局指标
主要结局
Psychiatric Health - Internalizing and Externalizing Symptoms of Childhood
时间窗: 1 Day
"Internalizing symptoms" and "Externalizing symptoms" subscales of the Child Behavior Checklist (CBCL)
次要结局
- Acceptability of Devices - Tolerability Scale(1 day)