An interventional study of 10-hour Time in Bed in Sleep, sponsored by Rutgers, The State University of New Jersey. Status unknown at 1 site in United States. Open to participants aged 14 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Other
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:
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.
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.
Rutgers, The State University of New Jersey is the lead sponsor of 504 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will not partake in the intervention, they will sleep the normal amount that they do on a regular basis. Participants will wear a hip physical activity monitor and a wrist actigraph to measure sleep.
This group will partake in the intervention of increasing time in bed to 10 hours per night. Participants will wear a hip physical activity monitor and a wrist actigraph to measure sleep.
Behavioral: 10-hour Time in Bed
Participants will be asked to increase their time in bed to 10-hours per night for 7 consecutive days.
Feasibility and Acceptability of Increasing Time in Bed to 10 hours per Night in Adolescents
An acceptability and feasibility questionnaire will be administered to participants at a follow up visit to measure the difficulty of increasing time in bed to 10 hours per night and wearing the two devices given. This questionnaire serves as feedback for the principal investigator to measure the feasibility of adolescents increasing time in bed to 10 hours per night and wearing two devices. Roughly half the questions are open ended and gauge the participants' physical experience during the study. The other half are scored 0-4 and ask about the participants' increase or decrease in school performance, overall mental health status, and physical health status during the day. For the questions that rank 0-4, a 0 indicates that specific aspect became a lot worse since the study, and a 4 indicates it became a lot better, or it increased over the course of the study.
Time frame: The questionnaire will take approximately 5-10 minutes.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All individual participant data that will be collected will be shared with other researchers, after deidentification.
Supporting information: Study protocol, Informed consent form
Time frame: Immediately following publication.
Access criteria: Anyone who wishes to access the data can do so.
Started Jul 2023 (actual). Primary completion is estimated for Jun 2024, 11 months after the start.
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This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey →