Dim Light Melatonin and/or methylxanthine for Circadian Rhythm Disorder

Sleep and Chronobiology Laboratory, Boulder, CO
Light Therapy +2 moreN/AWaitlist AvailableLed by Kenneth P. Wright, PhDResearch Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Study Summary

Jet lag and some sleep disorders are caused by a disruption in an individual's "internal clock." Understanding the most effective way to quickly re-adjust the body's internal clock will be beneficial for treating individuals with these conditions. This study will evaluate the combined effectiveness of light and non-light therapies at regulating sleep cycles and improving sleep quality.

Eligible Conditions
  • Circadian Rhythm Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overnight
This trial's timeline: 3 weeks for screening, Varies for treatment, and overnight for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit)
Secondary outcome measures
Circadian phase, as measured by the shift of the endogenous temperature rhythm
Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit)
Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Placebo and Dim Light or bright lightExperimental Treatment1 Intervention
Placebo and Dim Light or bright light
Group II: Dim Light Melatonin and/or methylxanthineExperimental Treatment2 Interventions
Dim Light Melatonin and/or methylxanthine
Group III: Bright light melatonin and/or methylxanthineExperimental Treatment3 Interventions
Bright light, melatonin, and/or methylxanthine
First Studied
Drug Approval Stage
How many patients have taken this drug
Light Therapy
Completed Phase 1
FDA approved

Find a site

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,713 Previous Clinical Trials
47,168,901 Total Patients Enrolled
Kenneth P. Wright, PhDPrincipal Investigator
University of Colorado at Boulder
1 Previous Clinical Trials
24 Total Patients Enrolled

Frequently Asked Questions

~3 spots leftby Sep 2024