Feasibility of a Bedtime Variability Protocol

NCT ID: NCT06501690

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2024-09-30

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).

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Habitual bedtime

For one week, children will follow their habitual bedtime.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Late bedtime

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

Group Type: EXPERIMENTAL

Late bedtime

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Variable bedtime

Intervention Type: BEHAVIORAL

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

Interventions

Late bedtime

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

Intervention Type: BEHAVIORAL

Variable bedtime

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Emily Hohman

Associate Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00025204

Identifier Type: -

Identifier Source: org_study_id