Shifting Sleep Timing in Teens

Not Applicable

Recruiting

• Conditions: Adolescent Behavior; Sleep Insufficiency; Sleep
• Interventions: Device: Light; Behavioral: CBT; Device: Sham Light

• Registration Number: NCT05808179
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Status Verified: 2023-04
• Study First Posted: 2023-04-11
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-21
• Primary Completion: 2026-06-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light + Cognitive Behavioral Therapy (CBT)	Light	1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
Sham light + CBT	CBT	1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Sham light + CBT	Sham Light	1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Light + Cognitive Behavioral Therapy (CBT)	CBT	1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
Total sleep time	20 weeks	Average nightly total sleep time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States