Feasibility of a Bedtime Variability Protocol

NCT06501690 | Completed

• 1 other identifier: STUDY00025204
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

sleep; bedtime

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

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

Behavioral: Late bedtime

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.

Behavioral: Variable bedtime

Interventions

Late bedtime BEHAVIORAL

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

Late bedtime

Variable bedtime BEHAVIORAL

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

Variable bedtime

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Model Details: Participants will complete 3, one week long intervention periods in a randomized order

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 15, 2024
• Study Start: July 10, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)