Clinical Research Directory

Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag

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. ...

A Study on the Effectiveness of a Dietary Supplement FitoAvia for Jet Lag

Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony Objectives of the study: 1. Assessment of the condition of patients with jet lag of 4 hours or more 2. Determination of the day of normalization of the circadian rhythm in each group 3. Assessing the quality of life of patients. 4. Assessment of the economic effectiveness of the therapy performed 5. Evaluation of the results of daily software testing for "staff" of at least 12 people from each group Randomization Block randomization with stratification. Randomization sheets will be provided prior to the start of the study. Sample size Total number of patients included in the study: up to 120. Study groups Group 2 - at least 60 patients in each group (Fitoavia/Placebo) with stratification within each group: Group 1, patients receiving: Fitoavia. Group 2 patients who received: Placebo. Stratification implies uniform inclusion of patients according to the amount of jet lag.