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)Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
In good general health, as determined by blood chemistries, urine toxicology, physical examination, and medical and psychiatric history
Be between 18 and 65 years old
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up24 hour
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ overnight
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overnight
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Light Therapy
2002
Completed Phase 1
~320
Melatonin
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 Boulder1 Previous Clinical Trials
24 Total Patients Enrolled
Frequently Asked Questions
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