Shifting Sleep Timing in Teens

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05808179
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 47.6
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Insufficiency; Sleep; Adolescent Behavior	Device: Light; Behavioral: CBT; Device: Sham Light	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Passive Phototherapy to Improve Sleep in Teens
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jun 20, 2026
• Anticipated Study Completion Date: Jun 20, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Light + Cognitive Behavioral Therapy (CBT) 1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy	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
Active Comparator: Sham light + CBT 1 hour of sham light flashes (one flash) and cognitive behavioral therapy	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

Outcome Measures

Primary Outcome Measures

1. Total sleep time [20 weeks]

   Average nightly total sleep time

Secondary Outcome Measures

1. Melatonin timing [8 weeks]

   Timing of the onset of salivary melatonin

2. Mood [20 weeks]

   Score on the Center for Epidemiologic Studies Depression Scale for Children. Scored 0-60 with higher scores indicating greater depressive symptomatology.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jamie M. Zeitzer, Ph.D., Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT05808179
• Other Study ID Numbers: 1R01HD102344
• First Posted: Apr 11, 2023
• Last Update Posted: Apr 13, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Deprivation

Study Results

No Results Posted as of Apr 13, 2023