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Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00387179
Recruitment Status : Unknown
Verified August 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was:  Recruiting
First Posted : October 12, 2006
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 11, 2006
First Posted Date  ICMJE October 12, 2006
Last Update Posted Date August 25, 2009
Study Start Date  ICMJE October 2006
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit) [ Time Frame: 24 hour ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2006)
Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
  • Circadian phase, as measured by the shift of the endogenous temperature rhythm [ Time Frame: 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 [ Time Frame: overnight ]
  • Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit) [ Time Frame: 24 h and daytime ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2006)
  • Circadian phase, as measured by the shift of the endogenous temperature rhythm
  • Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings
  • Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders
Official Title  ICMJE Circadian Integration of Photic and Non-photic Stimuli
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.
Detailed Description

Circadian rhythm disorders are disruptions in an individual's circadian rhythm, or "internal body clock." This internal clock regulates the 24-hour cycle of biological processes in the body, including sleep and hormone production. Jet lag, delayed sleep phase syndrome, in which individuals fall asleep and wake up later than desired, and advanced sleep phase syndrome, in which individuals fall asleep and wake up earlier than desired, are all examples of circadian rhythm disorders. Because of the disruptive nature of these conditions, it is important to identify the quickest and most effective method for regulating the body and reestablishing normal sleep patterns. Light therapy, in which individuals are exposed to bright, artificial light, is currently used to treat these disorders. Melatonin, a hormone that regulates circadian rhythms, and methylxanthines, a class of stimulant medications, are other common non-light treatments. While each of these individual treatments has been proven effective, little is known about the combined effect of light and non-light treatments. The purpose of this study is to evaluate the safety and effectiveness of light therapy, melatonin, and methylxanthine, alone and in combination, at regulating circadian rhythms and improving sleep quality and cognitive function.

This study will enroll healthy individuals. Participants will first attend two screening visits, which will include a review of medical, psychiatric, and sleep histories; vital sign measurements; blood and urine collection; a physical examination; and an electrocardiogram. For 1 week, participants will record sleep habits in a diary and by telephone. They will also wear a device that monitors activity and light exposure levels. Eligible participants will then attend four 5-day inpatient visits at the Sleep and Chronobiology Laboratory at the University of Colorado at Boulder. During each of the four visits, participants will be randomly assigned to one of the following four treatments:

  • Dim light therapy and placebo
  • Bright light therapy and placebo
  • Dim light therapy, melatonin, and methylxanthines
  • Bright light therapy, melatonin, and methylxanthines

At each visit, participants will receive a different treatment. During these visits, participants will remain awake for up to 40 hours at a time, while their eye movements, and brain, muscle, heart, and breathing activity are monitored. Urine and saliva will be collected, and participants will undergo various cognitive performance testing measures. At 3-week intervals between each visit, participants will record sleep habits and will wear the activity and light exposure monitoring device. A sleep diary will also be maintained by participants for 3 weeks following the end of the last visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Sleep Disorders, Circadian Rhythm
Intervention  ICMJE
  • Drug: Melatonin
    5mg, pill, once
    Other Name: Life Extension Melatonin 5 mg
  • Drug: Methylxanthine
    2.9 mg/kg, pill, once
  • Procedure: Light Therapy
    Bright light exposure
Study Arms  ICMJE
  • Experimental: Dim Light Melatonin and/or methylxanthine
    Dim Light Melatonin and/or methylxanthine
    Interventions:
    • Drug: Melatonin
    • Drug: Methylxanthine
  • Experimental: Placebo and Dim Light or bright light
    Placebo and Dim Light or bright light
    Intervention: Procedure: Light Therapy
  • Experimental: Bright light melatonin and/or methylxanthine
    Bright light, melatonin, and/or methylxanthine
    Interventions:
    • Drug: Melatonin
    • Drug: Methylxanthine
    • Procedure: Light Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 11, 2006)
48
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2010
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In good general health, as determined by blood chemistries, urine toxicology, physical examination, and medical and psychiatric history

Exclusion Criteria:

  • History of any current or chronic disease, including any of the following:

    1. Chronobiologic disorders
    2. Sleep disorders
    3. Cardiovascular disorders
    4. Respiratory disorders
    5. Kidney and urinary tract disorders
    6. Infectious diseases
    7. Gastrointestinal disorders
    8. Immune system disorders
    9. Connective tissue and joint disorders
    10. Hematopoietic disorders
    11. Neoplastic diseases
    12. Endocrine and metabolic diseases
    13. Neurologic disorders
  • Current or past history of drug abuse
  • Pregnant or breastfeeding
  • Current oral contraceptive use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387179
Other Study ID Numbers  ICMJE 406
M01RR000051 ( U.S. NIH Grant/Contract )
R01HL081761 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth P. Wright Jr., Ph.D., Associate Professor, University of Colorado
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth P. Wright, PhD University of Colorado at Boulder
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP