跳至主要内容
临床试验/NCT06501690
NCT06501690已完成不适用

Feasibility of a Bedtime Variability Protocol

Penn State University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年7月10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
入组人数
5
试验地点
1
主要终点
Adherence to bedtime protocol

研究概览

简要总结

The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol.

详细描述

The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. Children with medical conditions or taking medications affecting sleep, or children who do not have a regular bedtime, will be excluded. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol. Participants will attend an initial enrollment visit to complete consent and receive instruction on the protocol. Participants will then complete the three experimental conditions in a randomized, counterbalanced order. Participants will complete a phone or Zoom check in at the end of the first two conditions, and an in-person or Zoom visit at the end of the third condition where their opinions about the protocol feasibility and acceptability will be assessed, answer any questions, and provide them instruction for the next condition (when applicable).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Child age 6-10 years
  • •Parent age 18 years or older
  • •Child has a regular bedtime (goes to bed within 30 minutes of the same time on 5 or more days per week)

排除标准

  • •Child has a medical condition impacting sleep (e.g., narcolepsy, sleep apnea)
  • •Child has a developmental disorder or delay (e.g., autism, Down syndrome)
  • •Child regularly takes supplements or medications (prescription or over the counter) for sleep, such as melatonin or antihistamines
  • •Not English speaking
  • •Not willing to follow bedtime protocol
  • •Residing in the same household as a current or previous participant (i.e., only 1 child per household may complete study)

研究组 & 干预措施

Habitual bedtime

No Intervention

For one week, children will follow their habitual bedtime.

Late bedtime

Experimental

For one week, children will go to bed one hour later than their habitual bedtime

干预措施: Late bedtime (Behavioral)

Variable bedtime

Experimental

For one week, children will go to bed at a prescribed time that will vary each day within +/- 1 hour of habitual bedtime.

干预措施: Variable bedtime (Behavioral)

结局指标

主要结局

Adherence to bedtime protocol

时间窗: Daily during each of the 3, one-week intervention periods

Parents will report on the time their child went to bed

次要结局

  • Parent perception of feasibility of following the protocol (semi-structured interview)(At the end of 3 week study)
  • Sleep duration(Daily during each of the 3, one-week intervention period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Hohman

Associate Research Professor

Penn State University

研究点 (1)

Loading locations...

相似试验