Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT05251324

Conditions

Hot Flashes

Menopause

Eligibility Criteria

Sex: Female

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

Hot Flush Induction

Study Details

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.

Conditions

Hot Flashes

Menopause

Study ID

NCT05251324

Start date

Mar 1, 2022

Status verified date

Apr, 2026

Completion date

May 26, 2027

Anticipated

Primary completion date

May 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants With Hot Flushes (at least 3 per day)

At Visit 1, participants will complete informed consent, questionnaires regarding medical history, physical activity levels, stress and anxiety, menopause symptoms and a hot flush behavior scale. Visit one will be completed remotely using a HIPAA-compliant online platform or over the phone.

At Visit 2, baseline measurements will be recorded for two hours and spontaneous hot flushes will be detected. Participants will then have a temperature-controlled, water-circulating heating pad at a consistent temperature of 107˚F placed on their torso for 30 min, followed by five min of recovery. This will be followed by a blood draw to measure sex hormones. At either Visit 2 or a separate visit, participants will have a dual energy x-ray absorptiometry scan for a body composition assessment. For participants taking prescribed MHT, a standard protocol for enrollment and they may complete up to six study visits.

Participants Without Hot Flushes

At Visit 1, participants will complete informed consent, questionnaires regarding medical history, physical activity levels, stress and anxiety, menopause symptoms and a hot flush behavior scale. Visit one will be completed remotely using a HIPAA-compliant online platform or over the phone.

At Visit 2, baseline measurements will be recorded for two hours and spontaneous hot flushes will be detected. Participants will then have a temperature-controlled, water-circulating heating pad at a consistent temperature of 107˚F placed on their torso for 30 min, followed by five min of recovery. This will be followed by a blood draw to measure sex hormones. At either Visit 2 or a separate visit, participants will have a dual energy x-ray absorptiometry scan for a body composition assessment. For participants taking prescribed MHT, a standard protocol for enrollment and they may complete up to six study visits.

Interventions

Hot Flush Induction

A temperature-controlled, water-circulating heating pad at a constant temperature of 107˚F will be placed on the participant's torso, a microwaved heating neck pad will be placed on the participant's neck, and two warm balloons will be placed in the participant's hands for 30 min. Subjective (verbal start and end point to be marked on LabChart software) and objective (skin conductance and skin temperature) measures of hot flushes will be recorded.

Primary outcome measure

  • Systolic Blood pressure (mmHg) [ Time Frame: 3 hours ]
  • Diastolic Blood pressure [ Time Frame: 3 hours ]
  • Mean arterial Blood pressure [ Time Frame: 3 hours ]
  • Skin conductance [ Time Frame: 3 hours ]
  • Skin temperature [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Manda Keller-Ross, PhD, DPT, PT

(612) 625-3175kell0529@umn.edu

William Stokes

(443) 801-8778stoke123@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

May 7, 2026

Last verified

Apr, 2026

Keywords

  • Menopause

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-05-07.