Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders
Circadian Integration of Photic and Non-photic Stimuli
3 other identifiers
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedAugust 25, 2009
August 1, 2009
3.4 years
October 11, 2006
August 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit)
24 hour
Secondary Outcomes (3)
Circadian phase, as measured by the shift of the endogenous temperature rhythm
24 hour
Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings
overnight
Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit)
24 h and daytime
Study Arms (3)
Dim Light Melatonin and/or methylxanthine
EXPERIMENTALDim Light Melatonin and/or methylxanthine
Placebo and Dim Light or bright light
EXPERIMENTALPlacebo and Dim Light or bright light
Bright light melatonin and/or methylxanthine
EXPERIMENTALBright light, melatonin, and/or methylxanthine
Interventions
5mg, pill, once
2.9 mg/kg, pill, once
Bright light exposure
Eligibility Criteria
You may qualify if:
- In good general health, as determined by blood chemistries, urine toxicology, physical examination, and medical and psychiatric history
You may not qualify if:
- History of any current or chronic disease, including any of the following:
- Chronobiologic disorders
- Sleep disorders
- Cardiovascular disorders
- Respiratory disorders
- Kidney and urinary tract disorders
- Infectious diseases
- Gastrointestinal disorders
- Immune system disorders
- Connective tissue and joint disorders
- Hematopoietic disorders
- Neoplastic diseases
- Endocrine and metabolic diseases
- Neurologic disorders
- Current or past history of drug abuse
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sleep and Chronobiology Laboratory
Boulder, Colorado, 80309, United States
Related Publications (8)
Duffy JF, Wright KP Jr. Entrainment of the human circadian system by light. J Biol Rhythms. 2005 Aug;20(4):326-38. doi: 10.1177/0748730405277983.
PMID: 16077152BACKGROUNDWright KP Jr, Gronfier C, Duffy JF, Czeisler CA. Intrinsic period and light intensity determine the phase relationship between melatonin and sleep in humans. J Biol Rhythms. 2005 Apr;20(2):168-77. doi: 10.1177/0748730404274265.
PMID: 15834113BACKGROUNDGronfier C, Wright KP Jr, Kronauer RE, Jewett ME, Czeisler CA. Efficacy of a single sequence of intermittent bright light pulses for delaying circadian phase in humans. Am J Physiol Endocrinol Metab. 2004 Jul;287(1):E174-81. doi: 10.1152/ajpendo.00385.2003. Epub 2004 Mar 23.
PMID: 15039146BACKGROUNDBarger LK, Wright KP Jr, Hughes RJ, Czeisler CA. Daily exercise facilitates phase delays of circadian melatonin rhythm in very dim light. Am J Physiol Regul Integr Comp Physiol. 2004 Jun;286(6):R1077-84. doi: 10.1152/ajpregu.00397.2003. Epub 2004 Mar 18.
PMID: 15031136BACKGROUNDWright KP Jr, Czeisler CA. Absence of circadian phase resetting in response to bright light behind the knees. Science. 2002 Jul 26;297(5581):571. doi: 10.1126/science.1071697. No abstract available.
PMID: 12142528BACKGROUNDWright KP Jr, Hughes RJ, Kronauer RE, Dijk DJ, Czeisler CA. Intrinsic near-24-h pacemaker period determines limits of circadian entrainment to a weak synchronizer in humans. Proc Natl Acad Sci U S A. 2001 Nov 20;98(24):14027-32. doi: 10.1073/pnas.201530198.
PMID: 11717461BACKGROUNDWright KP Jr, Myers BL, Plenzler SC, Drake CL, Badia P. Acute effects of bright light and caffeine on nighttime melatonin and temperature levels in women taking and not taking oral contraceptives. Brain Res. 2000 Aug 11;873(2):310-7. doi: 10.1016/s0006-8993(00)02557-9.
PMID: 10930561BACKGROUNDWright KP Jr, Badia P, Myers BL, Plenzler SC, Hakel M. Caffeine and light effects on nighttime melatonin and temperature levels in sleep-deprived humans. Brain Res. 1997 Jan 30;747(1):78-84. doi: 10.1016/s0006-8993(96)01268-1.
PMID: 9042530BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth P. Wright, PhD
University of Colorado at Boulder
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 12, 2006
Study Start
October 1, 2006
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
August 25, 2009
Record last verified: 2009-08