Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501690
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-02
Brief Title:
Feasibility of a Bedtime Variability Protocol
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Feasibility of a Bedtime Variability Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None