Back to resultsShifting Sleep Timing in Teens
Primary Purpose
Sleep Insufficiency, Sleep, Adolescent Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light
CBT
Sham Light
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Insufficiency
Eligibility Criteria
Inclusion Criteria: Aged 14-18 and a full-time student in grades 9-12 Male or female Willing and with a schedule permitting them to go to bed at an earlier time Planning on sleeping at home in their bedroom for at least 75% of the study Exclusion Criteria: Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders Sleep only in the prone (face-down) position
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Light + Cognitive Behavioral Therapy (CBT)
Sham light + CBT
Arm Description
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Outcomes
Primary Outcome Measures
Total sleep time
Average nightly total sleep time
Secondary Outcome Measures
Melatonin timing
Timing of the onset of salivary melatonin
Mood
Score on the Center for Epidemiologic Studies Depression Scale for Children. Scored 0-60 with higher scores indicating greater depressive symptomatology.
Full Information
NCT ID
NCT05808179
First Posted
March 29, 2023
Last Updated
April 18, 2023
Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05808179
Brief Title
Shifting Sleep Timing in Teens
Official Title
Passive Phototherapy to Improve Sleep in Teens
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 20, 2026 (Anticipated)
Study Completion Date
June 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Insufficiency, Sleep, Adolescent Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Light + Cognitive Behavioral Therapy (CBT)
Arm Type
Experimental
Arm Description
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
Arm Title
Sham light + CBT
Arm Type
Active Comparator
Arm Description
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Intervention Type
Device
Intervention Name(s)
Light
Intervention Description
Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur every 20 s
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
Intervention Type
Device
Intervention Name(s)
Sham Light
Intervention Description
Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur once
Primary Outcome Measure Information:
Title
Total sleep time
Description
Average nightly total sleep time
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Melatonin timing
Description
Timing of the onset of salivary melatonin
Time Frame
8 weeks
Title
Mood
Description
Score on the Center for Epidemiologic Studies Depression Scale for Children. Scored 0-60 with higher scores indicating greater depressive symptomatology.
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 14-18 and a full-time student in grades 9-12
Male or female
Willing and with a schedule permitting them to go to bed at an earlier time
Planning on sleeping at home in their bedroom for at least 75% of the study
Exclusion Criteria:
Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
Sleep only in the prone (face-down) position
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Zeitzer, PhD
Phone
6504935000
Email
jzeitzer@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniz Keskinel
Email
denizkes@stanford.edu
First Name & Middle Initial & Last Name & Degree
Stella Rue
Email
srue@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Shifting Sleep Timing in Teens
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