NCT05703061

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

January 5, 2023

Last Update Submit

November 14, 2023

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • 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.

    The questionnaire will take approximately 5-10 minutes.

Study Arms (2)

Normal Sleep Condition Group

NO INTERVENTION

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.

10-hour Time in Bed Group

EXPERIMENTAL

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

Interventions

10-hour Time in BedBEHAVIORAL

Participants will be asked to increase their time in bed to 10-hours per night for 7 consecutive days.

10-hour Time in Bed Group

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Sleep Lab

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Publications (3)

  • 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.

    BACKGROUND

  • Actigraph Data Collection, Proofing, and Scoring Procedures AW2 2018

    BACKGROUND

  • 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.

    PMID: 23700330BACKGROUND

Related Links

MeSH Terms

Interventions

TimeBeds

Intervention Hierarchy (Ancestors)

Physical PhenomenaEquipment and Supplies, HospitalEquipment and Supplies

Study Officials

  • Andrea Spaeth, Ph.D

    Associate Professor, Lab Director

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor McCoy, B.S.

CONTACT

732-554-1532tm953@kines.rutgers.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be assigned to either a control group or an increased time in bed (10 hours/night) group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Undergraduate Academic Director

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 27, 2023

Study Start

July 1, 2023

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Immediately following publication.
Access Criteria
Anyone who wishes to access the data can do so.

Locations

US(1)