Feasibility of a Bedtime Variability Protocol

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Sleep

Treatments: Behavioral: Variable bedtime; Behavioral: Late bedtime

Study type: Interventional

Funder types: Other

Identifiers

NCT06501690

STUDY00025204

Details and patient eligibility

About

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.

Full 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).

Enrollment: 5 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

Habitual bedtime

No Intervention group

Description:

For one week, children will follow their habitual bedtime.

Late bedtime

Experimental group

Description:

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

Treatment:

Behavioral: Late bedtime

Variable bedtime

Experimental group

Description:

For one week, children will go to bed at a prescribed time that will vary each day within +/- 1 hour of habitual bedtime.

Treatment:

Behavioral: Variable bedtime