Shifting Sleep Timing in Teens

Study Overview
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Brief Summary
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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.

Official Title
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Passive Phototherapy to Improve Sleep in Teens

Conditions
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Sleep Insufficiency, Sleep, Adolescent Behavior

Intervention / Treatment
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* Device: Light
* Behavioral: CBT
* Device: Sham Light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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