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

NCT ID: NCT00387179

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-03-31

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.

Conditions

Sleep Disorders, Circadian Rhythm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Dim Light Melatonin and/or methylxanthine

Dim Light Melatonin and/or methylxanthine

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

5mg, pill, once

Methylxanthine

Intervention Type: DRUG

2.9 mg/kg, pill, once

Placebo and Dim Light or bright light

Placebo and Dim Light or bright light

Group Type: EXPERIMENTAL

Light Therapy

Intervention Type: PROCEDURE

Bright light exposure

Bright light melatonin and/or methylxanthine

Bright light, melatonin, and/or methylxanthine

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

5mg, pill, once

Methylxanthine

Intervention Type: DRUG

2.9 mg/kg, pill, once

Light Therapy

Intervention Type: PROCEDURE

Bright light exposure

Interventions

Melatonin

5mg, pill, once

Intervention Type: DRUG

Methylxanthine

2.9 mg/kg, pill, once

Intervention Type: DRUG

Light Therapy

Bright light exposure

Intervention Type: PROCEDURE

Other Intervention Names

Life Extension Melatonin 5 mg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

University of Colorado

Principal Investigators

Kenneth P. Wright, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado at Boulder

Locations

Sleep and Chronobiology Laboratory

Boulder, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gayle Wright, MS

Role: CONTACT

Sleep.Study@colorado.edu

303-735-1923

References

Wright 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.

Reference Type: BACKGROUND

PMID: 15834113 (View on PubMed)

Gronfier 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.

Reference Type: BACKGROUND

PMID: 15039146 (View on PubMed)

Barger 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.

Reference Type: BACKGROUND

PMID: 15031136 (View on PubMed)

Wright 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.

Reference Type: BACKGROUND

PMID: 12142528 (View on PubMed)

Wright 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.

Reference Type: BACKGROUND

PMID: 11717461 (View on PubMed)

Wright 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.

Reference Type: BACKGROUND

PMID: 10930561 (View on PubMed)

Wright 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.

Reference Type: BACKGROUND

PMID: 9042530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16077152 (View on PubMed)

Related Links

http://www.colorado.edu/intphys/research/sleep.html

Click here for the University of Colorado at Boulder Sleep and Chronobiology Laboratory web site

Other Identifiers

M01RR000051

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL081761

Identifier Type: NIH

Identifier Source: secondary_id

View Link

406

Identifier Type: -

Identifier Source: org_study_id