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Completed

NCT Number: NCT06501690

Feasibility of a Bedtime Variability Protocol

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.

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Key information

Conditions

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

Late bedtime

Behavioral

Participants will go to bed 1 hour later than their habitual bedtime

Variable bedtime

Behavioral

Participants will go to bed at a prescribed time that varies each day within +/-1 hour of habitual bedtime

Primary outcomes

  1. Adherence to bedtime protocol

    Time frame: Daily during each of the 3, one-week intervention periods

    Parents will report on the time their child went to bed

Secondary outcomes

  1. Parent perception of feasibility of following the protocol (semi-structured interview)

    Time frame: 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.

  2. Sleep duration

    Time frame: Daily during each of the 3, one-week intervention period

    Child sleep duration during each intervention period, measured by actigraphy

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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