NCT07138443 Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress
| NCT ID | NCT07138443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor University |
| Condition | Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-08 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 reduced cardiovascular and skin temperature responsiveness to acute mental stress.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07138443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07138443 currently recruiting?
Yes, NCT07138443 is actively recruiting participants. Contact the research team at jeremy_bigalke@baylor.edu for enrollment information.
Where is the NCT07138443 trial being conducted?
This trial is being conducted at Waco, United States.
Who is sponsoring the NCT07138443 clinical trial?
NCT07138443 is sponsored by Baylor University. The trial plans to enroll 20 participants.