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Dim Light Melatonin and/or methylxanthine for Circadian Rhythm Disorder

N/A
Waitlist Available
Led By Kenneth P. Wright, PhD
Research 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hour
Awards & highlights

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

Timeline

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

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 Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,833 Previous Clinical Trials
47,306,448 Total Patients Enrolled
Kenneth P. Wright, PhDPrincipal InvestigatorUniversity of Colorado at Boulder
1 Previous Clinical Trials
24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders
2006. "Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00387179.
All > Sleep Disorder > Melatonin
~3 spots leftby Apr 2025
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