Passive Phototherapy to Improve Sleep in Teens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Total sleep time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Light + Cognitive Behavioral Therapy (CBT)
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
Intervention: Light (Device)
Light + Cognitive Behavioral Therapy (CBT)
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
Intervention: CBT (Behavioral)
Sham light + CBT
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Intervention: CBT (Behavioral)
Sham light + CBT
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Intervention: Sham Light (Device)
Outcomes
Primary Outcomes
Total sleep time
Time Frame: 20 weeks
Average nightly total sleep time
Secondary Outcomes
- Melatonin timing(8 weeks)
- Mood(20 weeks)
Investigators
Jamie M. Zeitzer, Ph.D.
Professor
Stanford University