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

Sleep Disorders, Circadian Rhythm Clinical Trial

Official title:

Circadian Integration of Photic and Non-photic Stimuli

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00387179
• Other study ID #: 406
• Secondary ID: M01RR000051R01HL
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2006
• Last updated: August 24, 2009
• Start date: October 2006
• Est. completion date: March 2010

Study information

• Verified date: August 2009
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: Gayle Wright, MS
• Phone: 303-735-1923
• Email: Sleep.Study[@]colorado.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Intervention

Drug:
• Melatonin
5mg, pill, once
• Methylxanthine
2.9 mg/kg, pill, once

Procedure:
• Light Therapy
Bright light exposure

Locations

Country	Name	City	State
United States	Sleep and Chronobiology Laboratory	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Epub 2004 Mar 18. — View Citation

Duffy JF, Wright KP Jr. Entrainment of the human circadian system by light. J Biol Rhythms. 2005 Aug;20(4):326-38. Review. — View Citation

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. Epub 2004 Mar 23. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit)		24 hour	No
Secondary	Circadian phase, as measured by the shift of the endogenous temperature rhythm		24 hour	No
Secondary	Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings		overnight	No
Secondary	Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit)		24 h and daytime	No

External Links

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