Status:
COMPLETED
Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Jet Lag
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will examine the effects of cortisol (hydrocortisone), melatonin, a combination of cortisol and melatonin, and placebo (an inactive substance) on jet lag symptoms. Jet lag is a term used to...
Detailed Description
Jet lag resulting from rapid flight across several time zones is a common complaint of travelers. The symptoms of jet lag are primarily described as daytime sleepiness, fatigue, and impaired mental ef...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 18, but less than or equal to 65, male or female.
- Normal physical exam and laboratory results.
- Negative urinary pregnancy test 1 week prior to travel (pre-menopausal women).
- Planned eastward flight crossing 6-8 time zones between 30n and 50n latitudes.
- A minimum stay of 7 - 10 days abroad.
- Willingness and anticipated ability to comply with study procedures, including sleep and wake hours, saliva collection and questionnaire completion.
- Written informed consent.
- EXCLUSION CRITERIA:
- BMI less than or equal to 20 or greater than or equal to 30 kg/m.
- Current psychiatric or seizure disorder.
- Current sleep disorder as assessed by presence of sleep apnea, daytime napping of more than 20 minutes, chronic fatigue.
- History of Cushing's syndrome.
- Serious chronic medical condition.
- Current drug or alcohol abuse.
- SGOT or SGPT greater than three-fold normal.
- Current pregnancy or lactation.
- Current use of CPAP.
- Chronic use of beta-blockers (which inhibit melatonin secretion), anti-epileptic agents, anticoagulants, fluvoxamine, nifedipine or soporific or sleep-inducing agents (including benzodiazepines, melatonin), or glucocorticoids.
- Fasting blood glucose greater than 110 mg/dL or known diabetes.
Exclusion
Key Trial Info
Start Date :
December 21 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2007
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00097474
Start Date
December 21 2004
End Date
November 14 2007
Last Update
December 26 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892