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Feasibility of a Bedtime Variability Protocol

Feasibility of a Bedtime Variability Protocol

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06501690
Enrollment
5
Registered
2024-07-15
Start date
2024-07-10
Completion date
2024-09-30
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

sleep, bedtime

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).

Interventions

BEHAVIORALLate bedtime

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

BEHAVIORALVariable bedtime

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

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Adherence to bedtime protocolDaily during each of the 3, one-week intervention periodsParents will report on the time their child went to bed

Secondary

MeasureTime frameDescription
Parent perception of feasibility of following the protocol (semi-structured interview)At the end of 3 week studyParents 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.
Sleep durationDaily during each of the 3, one-week intervention periodChild sleep duration during each intervention period, measured by actigraphy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026