Recruiting

Light & Non-Light Treatments

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT00387179

Conditions

Sleep Disorders, Circadian Rhythm

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Melatonin

Methylxanthine

Light Therapy

Study Details

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.

Conditions

Sleep Disorders, Circadian Rhythm

Study ID

NCT00387179

Start date

Oct, 2006

Status verified date

Aug, 2009

Completion date

Mar, 2010

Anticipated

Primary completion date

Mar, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Dim Light Melatonin and/or methylxanthine

Dim Light Melatonin and/or methylxanthine

experimental: Placebo and Dim Light or bright light

Placebo and Dim Light or bright light

experimental: Bright light melatonin and/or methylxanthine

Bright light, melatonin, and/or methylxanthine

Interventions

Melatonin

5mg, pill, once

Methylxanthine

2.9 mg/kg, pill, once

Light Therapy

Bright light exposure

Primary outcome measure

  • Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit) [ Time Frame: 24 hour ]

Central Contacts and Locations

Central contacts

Gayle Wright, MS

303-735-1923Sleep.Study@colorado.edu

Locations

Sleep and Chronobiology Laboratory

Recruiting

Boulder, Colorado, United States, 80309

Principal Investigator:

Kenneth P. Wright, PhD

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Aug 25, 2009

Last verified

Aug, 2009

Keywords

  • Circadian Rhythm Sleep Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2009-08-25.