RECRUITING

Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress

Conditions

Stress Mental Stress Melatonin Trier Social Stress Test Cardiovascular Skin temperature

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Influence of Melatonin on Cardiovascular and Skin Temperature Responses to Stress: A Randomized Controlled Trial

Quick Facts

Study Start:2025-08

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07138443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Jeremy A Bigalke, PhD

CONTACT

2547104399

jeremy_bigalke@baylor.edu

Anna Murvich

CONTACT

254-710-4475

anna_muvich@baylor.edu

Study Locations (Sites)

Baylor University Autonomic Function Laboratory

Waco, Texas, 76706

United States

Collaborators and Investigators

Sponsor: Baylor University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2026-08

Study Record Updates

Study Start Date2025-08

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Melatonin
Mental stress
Trier Social Stress Test
Cardiovascular
Skin temperature

Additional Relevant MeSH Terms

Stress
Mental Stress