RECRUITING

Sleep in Adolescents - Pilot Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sleep in Adolescents - Pilot Study

Quick Facts

Study Start:2023-07-01
Study Completion:2024-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05703061

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Parent-reported child age of 14-17 years
  2. * Typical sleep duration of approximately 7hr/night on school nights
  3. * BMI for age and gender in the \>5th percentile but not greater than 100% overweight.
  4. * Parent must be the primary caretaker and at home during bed/wake times
  5. * Reported willingness and ability to complete all study-related tasks, including wearing the wrist actigraph and hip accelerometer daily.
  1. * Diagnosable sleep disorder (including Sleep Disordered Breathing) based on parent report and participant's score on Sleep Disorders Inventory for Students-Adolescents (SDIS-A).
  2. * Medication use or parent-reported diagnosis of a serious medical condition (including psychiatric conditions) that may impact sleep.
  3. * Excessive intake of caffeine (\>300mg/day), drug (including nicotine) or alcohol use, or a history of substance abuse.
  4. * Actively trying to lose weight.
  5. * Trans-meridian (east-west/west-east) travel during past month or planned travel during study time frame.
  6. * Inability to understand or complete protocol to ensure that consent/assent and reliable and valid measures are obtained.
  7. * Sibling of enrolled subjects, to minimize risk of bias in study findings.

Contacts and Locations

Study Contact

Taylor McCoy, B.S.
CONTACT
732-554-1532
tm953@kines.rutgers.edu

Principal Investigator

Andrea Spaeth, Ph.D
PRINCIPAL_INVESTIGATOR
Associate Professor, Lab Director

Study Locations (Sites)

Rutgers Sleep Lab
New Brunswick, New Jersey, 08901
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Andrea Spaeth, Ph.D, PRINCIPAL_INVESTIGATOR, Associate Professor, Lab Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01
Study Completion Date2024-08

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2024-08

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep