Sleep in Adolescents - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility and Acceptability of Increasing Time in Bed to 10 hours per Night in Adolescents
研究概览
简要总结
The goal of this pilot clinical trial is to determine the feasibility and acceptability of increasing time in bed to 10 hours per night in children aged 14-17 years. The main question it aims to answer are:
- How much additional sleep short-sleeping-adolescents (~7h TIB/night) will obtain when asked to increase time-in-bed to 10h/night for seven consecutive nights compared to those who are not asked to increase time-in-bed?
- Are adolescents able to comply with study demands: wearing two devices (one on wrist and one on hip) and completing daily sleep diaries and call-ins for seven days?
- By acquiring participant feedback, how feasible and acceptable is it to increase time in bed for sleep to 10h/night using a questionnaire and semi-structured interview?
- Complete a phone screen
- Come to Rutgers Sleep Lab for an orientation to obtain equipment, answer questionnaires and study staff will obtain consent
- Wear a wrist device and a hip device for one week to observe sleep and physical activity
- If assigned to the 10 hour time-in-bed group, they will follow specific procedures to ensure protocol adherence
- Come to the Rutgers Sleep Lab for a follow up to give back equipment and answer questionnaires
Researchers will compare the control group to the 10 hour time in bed group to see if it is feasible for 14-17 year olds to be in bed for that long and wear two devices.
详细描述
We are conducting this research study to determine if it is feasible to have teenagers devote more time to being in bed for sleep. Specifically, we will try to determine how much more teens sleep when spending 10 hours in bed for a week. If after it is determined from a phone screen that the child is eligible, they will be asked to come into our Center for an Orientation.
During this visit, we will explain the research study to participants and families in more detail. Families that enroll will visit the Center one more time at the end of the study. During the orientation visit, we will determine the child's final eligibility based on how much he/she sleeps and a measurement of the child's height and weight. If eligible and interested in participating, the child would wear two devices -one that measures sleep and one that measures activity - and keep a sleep diary for a week. During this week, the child would also call/text our Center twice each day to report on his/her bedtime and wake time. The second visit to the center occurs at the end of that week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent-reported child age of 14-17 years
- •Typical sleep duration of approximately 7hr/night on school nights
- •BMI for age and gender in the >5th percentile but not greater than 100% overweight.
- •Parent must be the primary caretaker and at home during bed/wake times
- •Reported willingness and ability to complete all study-related tasks, including wearing the wrist actigraph and hip accelerometer daily.
排除标准
- •Diagnosable sleep disorder (including Sleep Disordered Breathing) based on parent report and participant's score on Sleep Disorders Inventory for Students-Adolescents (SDIS-A).
- •Medication use or parent-reported diagnosis of a serious medical condition (including psychiatric conditions) that may impact sleep.
- •Excessive intake of caffeine (>300mg/day), drug (including nicotine) or alcohol use, or a history of substance abuse.
- •Actively trying to lose weight.
- •Trans-meridian (east-west/west-east) travel during past month or planned travel during study time frame.
- •Inability to understand or complete protocol to ensure that consent/assent and reliable and valid measures are obtained.
- •Sibling of enrolled subjects, to minimize risk of bias in study findings.
结局指标
主要结局
Feasibility and Acceptability of Increasing Time in Bed to 10 hours per Night in Adolescents
时间窗: The questionnaire will take approximately 5-10 minutes.
An acceptability and feasibility questionnaire will be administered to participants at a follow up visit to measure the difficulty of increasing time in bed to 10 hours per night and wearing the two devices given. This questionnaire serves as feedback for the principal investigator to measure the feasibility of adolescents increasing time in bed to 10 hours per night and wearing two devices. Roughly half the questions are open ended and gauge the participants' physical experience during the study. The other half are scored 0-4 and ask about the participants' increase or decrease in school performance, overall mental health status, and physical health status during the day. For the questions that rank 0-4, a 0 indicates that specific aspect became a lot worse since the study, and a 4 indicates it became a lot better, or it increased over the course of the study.
次要结局
未报告次要终点
研究者
Andrea M. Spaeth, PhD
Assistant Professor, Undergraduate Academic Director
Rutgers, The State University of New Jersey