Feasibility of a Bedtime Variability Protocol
- Conditions
- Sleep
- Registration Number
- NCT06501690
- Lead Sponsor
- Penn State University
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Adherence to bedtime protocol Daily during each of the 3, one-week intervention periods Parents will report on the time their child went to bed
- Secondary Outcome Measures
Name Time Method Parent perception of feasibility of following the protocol (semi-structured interview) At the end of 3 week study Parents will provide qualitative answers to questions about their perceptions of following the protocol, including but not limited to whether the protocol was easy to follow, disruptive to their life, disruptive to their child's life.
Sleep duration Daily during each of the 3, one-week intervention period Child sleep duration during each intervention period, measured by actigraphy
Trial Locations
- Locations (1)
Pennsylvania State University
🇺🇸University Park, Pennsylvania, United States
Pennsylvania State University🇺🇸University Park, Pennsylvania, United States