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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Late bedtime; Behavioral: Variable bedtime

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).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Habitual bedtime; For one week, children will follow their habitual bedtime.
Experimental: Late bedtime; For one week, children will go to bed one hour later than their habitual bedtime	Behavioral: Late bedtime; Participants will go to bed 1 hour later than their habitual bedtime
Experimental: Variable bedtime; For one week, children will go to bed at a prescribed time that will vary each day within +/- 1 hour of habitual bedtime.	Behavioral: Variable bedtime; Participants will go to bed at a prescribed time that varies each day within +/-1 hour of habitual bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to bedtime protocol	Parents will report on the time their child went to bed	Daily during each of the 3, one-week intervention periods

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent perception of feasibility of following the protocol (semi-structured interview)	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.	At the end of 3 week study
Sleep duration	Child sleep duration during each intervention period, measured by actigraphy	Daily during each of the 3, one-week intervention period

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: sleep; bedtime
• Other Study ID Numbers: STUDY00025204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No