Clinical trial NCT05703061: Sleep in Adolescents - Pilot Study
Official title: Sleep in Adolescents - Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either a control group or an increased time in bed (10 hours/night) group.
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* Parent-reported child age of 14-17 years
* Typical sleep duration of approximately 7hr/night on school nights
* BMI for age and gender in the \>5th percentile but not greater than 100% overweight.
* Parent must be the primary caretaker and at home during bed/wake times
* Reported willingness and ability to complete all study-related tasks, including wearing the wrist actigraph and hip accelerometer daily.

Exclusion Criteria:

* Diagnosable sleep disorder (including Sleep Disordered Breathing) based on parent report and participant's score on Sleep Disorders Inventory for Students-Adolescents (SDIS-A).
* Medication use or parent-reported diagnosis of a serious medical condition (including psychiatric conditions) that may impact sleep.
* Excessive intake of caffeine (\>300mg/day), drug (including nicotine) or alcohol use, or a history of substance abuse.
* Actively trying to lose weight.
* Trans-meridian (east-west/west-east) travel during past month or planned travel during study time frame.
* Inability to understand or complete protocol to ensure that consent/assent and reliable and valid measures are obtained.
* Sibling of enrolled subjects, to minimize risk of bias in study findings.

Primary outcomes:
measure: Feasibility and Acceptability of Increasing Time in Bed to 10 hours per Night in Adolescents
timeFrame: The questionnaire will take approximately 5-10 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Sleep Lab
state: New Jersey
Study officials:
affiliation: Associate Professor, Lab Director
name: Andrea Spaeth, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luginbuehl M B-KK, Ferron J, Anderson WM, Benbadis SR. Pediatric sleep disorders: Validation of the SleepDisorders Inventory for Students. . School Psychol Rev. 2008; 37(3):409-31.
citation: Actigraph Data Collection, Proofing, and Scoring Procedures AW2 2018
citation: Santos-Lozano A, Santin-Medeiros F, Cardon G, Torres-Luque G, Bailon R, Bergmeir C, Ruiz JR, Lucia A, Garatachea N. Actigraph GT3X: validation and determination of physical activity intensity cut points. Int J Sports Med. 2013 Nov;34(11):975-82. doi: 10.1055/s-0033-1337945. Epub 2013 May 22.