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Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders
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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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 Sleep Disorder
- Circadian Rhythm Disorder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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 Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,938 Previous Clinical Trials
47,792,250 Total Patients Enrolled
Kenneth P. Wright, PhDPrincipal InvestigatorUniversity of Colorado at Boulder
1 Previous Clinical Trials
24 Total Patients Enrolled