Status:
RECRUITING
Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress
Lead Sponsor:
Baylor University
Conditions:
Stress
Mental Stress
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study aims to evaluate the influence of acute oral melatonin supplementation on cardiovascular and skin temperature responses to mental stress. The hypothesis is that acute melatonin will lead to...
Detailed Description
This study will utilize a randomized, crossover, placebo controlled experimental approach to determine the effects of acute oral melatonin supplementation (3mg) on blood pressure, heart rate, and regi...
Eligibility Criteria
Inclusion
- Must be between the ages of 18-70 years old.
- All subjects will be required to abstain from exercise and caffeine for 12 h, and alcohol for 24 h prior to the experiment.
- BMI must be \<30 kg/m2.
- Menstruating women will initially be tested during their early follicular phase (2-5 days after initiating menstruation) or during low hormone phase (2-5 days after initiating menstruation) if on oral contraceptives to control for potential impact of sex steroids. Post-menopausal females (\>5 years) will also be included. Females must have an intact uterus and at least one ovary. Use of hormonal replacement therapy will be allowed.
Exclusion
- Circadian rhythm sleep disorders
- High obstructive sleep apnea diagnosis determined by STOP-BANG.
- History of meeting Diagnostic and Statistical Manual of Mental health (DSM-V) criteria of major psychiatric disorder
- Unstable or serious medical conditions (heart failure, diabetes, cardiovascular disease, etc.)
- Current, or use within past month, of psychoactive (other than stable treatment with antidepressant), hypnotic, stimulant or analgesic medication (except occasional non-narcotic analgesics), beta blockers, or alpha blockers
- Shift work or other types of self-imposed irregular sleep schedules
- Habitual smoking (6 or more cigarettes per week)
- Habitual alcohol consumption (more than 2 alcoholic drinks per day)
- Pregnancy or breast feeding
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07138443
Start Date
August 1 2025
End Date
August 1 2026
Last Update
August 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor University Autonomic Function Laboratory
Waco, Texas, United States, 76706