NCT05251324 The Cardiovascular Impact of Hot Flushes
| NCT ID | NCT05251324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Hot Flashes |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-05-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-03-01 with a primary completion date of 2027-05-26.
⚠ 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
The overall objective of this study is to examine the physiological responses that occur during a hot flush in postmenopausal women. The following specific aims will be executed to reach the overall objective of this study. Aim 1: To determine if hot flushes can be reliably induced with a temperature-controlled, water- circulating (TCWC) heating pad. Based on previous research, the investigators hypothesize that hot flushes will be inducible with the TCWC in symptomatic women, but not in asymptomatic women. Aim 2: To determine if heat-induced hot flushes in symptomatic women will cause reproducible cardiovascular and respiratory responses. The investigators hypothesize that heat-induced hot flushes produce similar and reproducible cardiovascular and respiratory responses to spontaneous hot flushes. Aim 3: To determine if body fat percentage influences hot flush severity or frequency during spontaneous or induced hot flushes. The investigators hypothesize that women with higher body fat have reduced hot flash severity and frequency.
Eligibility Criteria
Inclusion Criteria: * Postmenopausal (may have or may not have hot flushes) * Have not started hormone therapy and/or will discontinue hormone therapy for the duration of the study Exclusion Criteria: * Reported nicotine/tobacco use within the last six months * Diabetic or asthmatic * Diagnosed significant carotid stenosis * History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury * Existing metabolic or endocrine abnormalities * Use of heart/blood pressure medications that are determined to interfere with study outcomes * Unwilling to discontinue use of OC (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or MHT * Pregnant or breastfeeding * Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two or three * Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three * Unwilling or unable to fast in the eight hours before visit two or three * Body mass index greater than or equal to 35 kg/m\^3
Contact & Investigator
Manda Keller-Ross, PhD, DPT, PT
PRINCIPAL INVESTIGATOR
University of Minnesota Medical School Department of Rehabilitation Medicine
Frequently Asked Questions
Who can join the NCT05251324 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 70 Years, studying Hot Flashes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05251324 currently recruiting?
Yes, NCT05251324 is actively recruiting participants. Contact the research team at kell0529@umn.edu for enrollment information.
Where is the NCT05251324 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05251324 clinical trial?
NCT05251324 is sponsored by University of Minnesota. The principal investigator is Manda Keller-Ross, PhD, DPT, PT at University of Minnesota Medical School Department of Rehabilitation Medicine. The trial plans to enroll 60 participants.