Shifting Sleep Timing in Teens

Stanford University

Status: Enrolling

Conditions: Sleep Insufficiency; Adolescent Behavior; Sleep

Treatments: Device: Sham Light; Device: Light; Behavioral: CBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05808179

1R01HD102344

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Light + Cognitive Behavioral Therapy (CBT)

Experimental group

Description:

1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy

Treatment:

Behavioral: CBT

Device: Light

Sham light + CBT

Active Comparator group

Description:

1 hour of sham light flashes (one flash) and cognitive behavioral therapy

Treatment:

Behavioral: CBT

Device: Sham Light