Clinical trial NCT06501690: Feasibility of a Bedtime Variability Protocol
Official title: Feasibility of a Bedtime Variability Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: sleep
bedtime
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 5
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete 3, one week long intervention periods in a randomized order
Primary purpose: OTHER

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).

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)

Primary outcomes:
measure: Adherence to bedtime protocol
timeFrame: Daily during each of the 3, one-week intervention periods
Secondary outcomes:
measure: Parent perception of feasibility of following the protocol (semi-structured interview)
timeFrame: At the end of 3 week study
measure: Sleep duration
timeFrame: Daily during each of the 3, one-week intervention period
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
References: