Shifting Sleep Timing in Teens

Sleep Clinical Trial

Official title:

Passive Phototherapy to Improve Sleep in Teens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808179
• Other study ID #: 1R01HD102344
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 20, 2026

Study information

• Verified date: April 2023
• Source: VA Palo Alto Health Care System
• Contact: Jamie Zeitzer, PhD
• Phone: 6504935000
• Email: jzeitzer[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 20, 2026
• Est. primary completion date: June 20, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Sleep
• Sleep Deprivation

Intervention

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

Device:
• Sham Light
Broad-spectrum white light flashes are ~4000 lux, 2 msec long, occur once

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep time	Average nightly total sleep time	20 weeks
Secondary	Melatonin timing	Timing of the onset of salivary melatonin	8 weeks
Secondary	Mood	Score on the Center for Epidemiologic Studies Depression Scale for Children. Scored 0-60 with higher scores indicating greater depressive symptomatology.	20 weeks