Shifting Sleep Timing in Teens

April 18, 2023 updated by: Jamie M. Zeitzer, Ph.D., Stanford University

Passive Phototherapy to Improve Sleep in Teens

The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. The main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

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

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged 14-18 and a full-time student in grades 9-12
  2. Male or female
  3. Willing and with a schedule permitting them to go to bed at an earlier time
  4. Planning on sleeping at home in their bedroom for at least 75% of the study

Exclusion Criteria:

  1. Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
  2. Sleep only in the prone (face-down) position

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Light + Cognitive Behavioral Therapy (CBT)
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
Device: Light
Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur every 20 s
Behavioral: CBT
Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
Active Comparator: Sham light + CBT
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Behavioral: CBT
Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
Device: Sham Light
Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sleep time
Time Frame: 20 weeks
Average nightly total sleep time
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melatonin timing
Time Frame: 8 weeks
Timing of the onset of salivary melatonin
8 weeks
Mood
Time Frame: 20 weeks
Score on the Center for Epidemiologic Studies Depression Scale for Children. Scored 0-60 with higher scores indicating greater depressive symptomatology.
20 weeks

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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, 2022

Primary Completion (Anticipated)

June 20, 2026

Study Completion (Anticipated)

June 20, 2026

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HD102344 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be made freely available on Dryad.com. Study protocol, analysis plan, consent form (unsigned), and analytic code will be made available upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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