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Light Therapy + CBT for Teen Sleep Deprivation
N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Must not have
Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a light/behavior combo can help teens sleep longer and improve mood/cognitive performance.
Who is the study for?
This trial is for teens aged 14-18 who are full-time students in grades 9-12. They should be willing and able to go to bed earlier, and plan on sleeping at home most of the time during the study. Teens taking sleep medications or those who only sleep face-down cannot participate.
What is being tested?
The trial tests if a new lighting intervention combined with behavioral therapy (CBT) can help teens sleep longer. It checks whether this approach not only increases total sleep time but also improves mood and cognitive performance over an extended period.
What are the potential side effects?
Since the interventions involve light exposure and behavioral therapy, side effects might include discomfort from changes in light patterns or stress due to alterations in bedtime routines, but no severe physical side effects are expected.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking medication for sleep problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total sleep time
Secondary study objectives
Melatonin timing
Mood
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Light + Cognitive Behavioral Therapy (CBT)Experimental Treatment2 Interventions
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
Group II: Sham light + CBTActive Control2 Interventions
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Light
2016
Completed Phase 4
~90
CBT
2013
Completed Phase 3
~4220
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,909 Total Patients Enrolled
7 Trials studying Sleep
51,141 Patients Enrolled for Sleep
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,384 Total Patients Enrolled
9 Trials studying Sleep
1,937 Patients Enrolled for Sleep
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.I am between 14 and 18 years old and currently in high school.I am taking medication for sleep problems.You must be willing and have a schedule that allows you to go to bed early.You only sleep on your stomach.
Research Study Groups:
This trial has the following groups:- Group 1: Light + Cognitive Behavioral Therapy (CBT)
- Group 2: Sham light + CBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.