Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-01 @ 6:59 PM
Study NCT ID:
NCT05703061
Status:
UNKNOWN
Last Update Posted:
2023-11-15
First Post:
2023-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep in Adolescents - Pilot Study
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
Sleep in Adolescents - Pilot Study
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
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 goal of this pilot clinical trial is to determine the feasibility and acceptability of increasing time in bed to 10 hours per night in children aged 14-17 years. The main question it aims to answer are:
* How much additional sleep short-sleeping-adolescents (\~7h TIB/night) will obtain when asked to increase time-in-bed to 10h/night for seven consecutive nights compared to those who are not asked to increase time-in-bed?
* Are adolescents able to comply with study demands: wearing two devices (one on wrist and one on hip) and completing daily sleep diaries and call-ins for seven days?
* By acquiring participant feedback, how feasible and acceptable is it to increase time in bed for sleep to 10h/night using a questionnaire and semi-structured interview?
* Complete a phone screen
* Come to Rutgers Sleep Lab for an orientation to obtain equipment, answer questionnaires and study staff will obtain consent
* Wear a wrist device and a hip device for one week to observe sleep and physical activity
* If assigned to the 10 hour time-in-bed group, they will follow specific procedures to ensure protocol adherence
* Come to the Rutgers Sleep Lab for a follow up to give back equipment and answer questionnaires
Researchers will compare the control group to the 10 hour time in bed group to see if it is feasible for 14-17 year olds to be in bed for that long and wear two devices.
* How much additional sleep short-sleeping-adolescents (\~7h TIB/night) will obtain when asked to increase time-in-bed to 10h/night for seven consecutive nights compared to those who are not asked to increase time-in-bed?
* Are adolescents able to comply with study demands: wearing two devices (one on wrist and one on hip) and completing daily sleep diaries and call-ins for seven days?
* By acquiring participant feedback, how feasible and acceptable is it to increase time in bed for sleep to 10h/night using a questionnaire and semi-structured interview?
* Complete a phone screen
* Come to Rutgers Sleep Lab for an orientation to obtain equipment, answer questionnaires and study staff will obtain consent
* Wear a wrist device and a hip device for one week to observe sleep and physical activity
* If assigned to the 10 hour time-in-bed group, they will follow specific procedures to ensure protocol adherence
* Come to the Rutgers Sleep Lab for a follow up to give back equipment and answer questionnaires
Researchers will compare the control group to the 10 hour time in bed group to see if it is feasible for 14-17 year olds to be in bed for that long and wear two devices.
Detailed Description:
We are conducting this research study to determine if it is feasible to have teenagers devote more time to being in bed for sleep. Specifically, we will try to determine how much more teens sleep when spending 10 hours in bed for a week. If after it is determined from a phone screen that the child is eligible, they will be asked to come into our Center for an Orientation.
During this visit, we will explain the research study to participants and families in more detail. Families that enroll will visit the Center one more time at the end of the study. During the orientation visit, we will determine the child's final eligibility based on how much he/she sleeps and a measurement of the child's height and weight. If eligible and interested in participating, the child would wear two devices -one that measures sleep and one that measures activity - and keep a sleep diary for a week. During this week, the child would also call/text our Center twice each day to report on his/her bedtime and wake time. The second visit to the center occurs at the end of that week.
During this visit, we will explain the research study to participants and families in more detail. Families that enroll will visit the Center one more time at the end of the study. During the orientation visit, we will determine the child's final eligibility based on how much he/she sleeps and a measurement of the child's height and weight. If eligible and interested in participating, the child would wear two devices -one that measures sleep and one that measures activity - and keep a sleep diary for a week. During this week, the child would also call/text our Center twice each day to report on his/her bedtime and wake time. The second visit to the center occurs at the end of that week.
Study Oversight
Has Oversight DMC:
False
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?: