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

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00387179
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
41
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Circadian Integration of Photic and Non-photic Stimuli
Study Start Date :
Oct 1, 2006
Anticipated Primary Completion Date :
Mar 1, 2010
Anticipated Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dim Light Melatonin and/or methylxanthine

Dim Light Melatonin and/or methylxanthine

Drug: Melatonin
5mg, pill, once
Other Names:
  • Life Extension Melatonin 5 mg

    • Drug: Methylxanthine
    2.9 mg/kg, pill, once
    Experimental: Placebo and Dim Light or bright light

    Placebo and Dim Light or bright light

    Procedure: Light Therapy
    Bright light exposure
    Experimental: Bright light melatonin and/or methylxanthine

    Bright light, melatonin, and/or methylxanthine

    Drug: Melatonin
    5mg, pill, once
    Other Names:
  • Life Extension Melatonin 5 mg

    • Drug: Methylxanthine
    2.9 mg/kg, pill, once

    Procedure: Light Therapy
    Bright light exposure

    Outcome Measures

    Primary Outcome Measures

    1. Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit) [24 hour]

    Secondary Outcome Measures

    1. Circadian phase, as measured by the shift of the endogenous temperature rhythm [24 hour]

    2. Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings [overnight]

    3. Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit) [24 h and daytime]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sleep and Chronobiology Laboratory Boulder Colorado United States 80309

    Sponsors and Collaborators

    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Kenneth P. Wright, PhD, University of Colorado at Boulder

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00387179
    Other Study ID Numbers:
    • 406
    • M01RR000051
    • R01HL081761
    First Posted:
    Oct 12, 2006
    Last Update Posted:
    Aug 25, 2009
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    Circadian Rhythm Sleep Disorders
    Additional relevant MeSH terms:
    Sleep Wake Disorders
    Parasomnias
    Sleep Disorders, Circadian Rhythm
    Melatonin

    Study Results

    No Results Posted as of Aug 25, 2009