Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag
Status:
Completed
Trial end date:
2007-11-14
Target enrollment:
Participant gender:
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 describe symptoms people commonly experience after rapid travel across several
time zones. The cause of jet lag is not known, but various hormones, including cortisol and
melatonin, have a day-to-night pattern of secretion and play a role in maintaining the body's
internal rhythms. This study will test whether taking cortisol, melatonin, or both can help
re-establish the body's day-night cycle and result in less jet lag.
People between 18 and 65 years of age who are planning a non-stop eastward flight with the
following characteristics may be eligible for this study:
- Crossing six to eight time zones (6 to 8 hours difference between Eastern Standard Time
and the destination)
- Destination between 30 and 50 latitudes (approximately Cairo to London)
- Evening flight (5 PM to midnight) with morning arrival
- Remaining abroad at least 4-10 days
Candidates must have a body mass index (BMI) between 20 and 30 kg/M (not too thin and not
overweight) and must not be taking medicines that affect sleep or cortisol or melatonin
levels. Prospective participants are screened with a medical history, blood tests, and check
of blood pressure, height, and weight.
Pre-flight Procedures
Participants keep a sleep journal 3 days before the flight. For 1 day within 3 days of the
flight they fill out jet lag and sleepiness questionnaires and collect morning and bedtime
saliva samples for measurement of cortisol and melatonin. The saliva is collected by chewing
on two small cotton pads and spitting them into a tube. Premenopausal women provide a urine
sample the week before the flight to test for pregnancy. On the day of the flight, the
participants do not collect saliva or fill out sleep logs or questionnaires. They are given
two bottles with study medication. One bottle, labeled "AM," contains either hydrocortisone
or placebo; the other, labeled "PM," contains either melatonin or placebo.
Post-flight Procedures
Upon arriving at their destination in the morning, participants obtain a saliva sample and
take one of the capsules in the "AM" bottle. At bedtime, they collect saliva and then take
one of the "PM" capsules. They repeat the medication doses for a total of 4 days and repeat
the saliva collections on days 2 through 4, 7 and 10 after arrival. In addition, participants
complete jet lag and sleep questionnaires in the morning, afternoon, and just before bedtime
on the day of arrival and on days 2 through 4, 7 and 10.
After they return from their trip, participants are seen at the NIH Clinic to bring in their
saliva specimens and review their questionnaires with study investigators.
...
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)