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Shifting Sleep Timing in Teens

ConditionsSleep InsufficiencySleepAdolescent Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-18
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Light

    Device

    Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur every 20 s

  • CBT

    Behavioral

    Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing

  • Sham Light

    Device

    Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur once

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Light + Cognitive Behavioral Therapy (CBT)Experimental treatment 2 interventions
Group B: Sham light + CBTActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Total sleep time

Average nightly total sleep time

Time frame
20 weeks

Secondary outcomes

1

Melatonin timing

Timing of the onset of salivary melatonin

Time frame
8 weeks
2

Mood

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

Time frame
20 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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