Sleep in Adolescents - Pilot Study

November 14, 2023 updated by: Andrea M. Spaeth, PhD, Rutgers, The State University of New Jersey

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Sleep Lab
        • Contact:
        • Principal Investigator:
          • Andrea Spaeth, Ph.D

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.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normal Sleep Condition Group
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.
Experimental: 10-hour Time in Bed Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Acceptability of Increasing Time in Bed to 10 hours per Night in Adolescents
Time Frame: The questionnaire will take approximately 5-10 minutes.
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.
The questionnaire will take approximately 5-10 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Andrea Spaeth, Ph.D, Associate Professor, Lab Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro2018000606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data that will be collected will be shared with other researchers, after deidentification.

IPD Sharing Time Frame

Immediately following publication.

IPD Sharing Access Criteria

Anyone who wishes to access the data can do so.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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