What this trial studies
The purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve activity and sleep.
Conditions in scope
- Menopause
- Hot Flashes
- Blood Pressure Regulation
Interventions
- High-Resistance Inspiratory Muscle Strength Training (Behavioral) — Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6.
- Low-Resistance Inspiratory Muscle Strength Training (Behavioral) — Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.
- POWERbreathe K3 device (Device) — Inspiratory muscle training device
Who can join
Women only · Ages 45 Years to 60 Years · Accepts healthy volunteers.
Inclusion criteria
- Females aged 45-60 with hot flashes.
- Participants will be recruited from Rochester, MN and surrounding areas.
- Non-smokers.
- BMI \< 40kg/m\^2.
- No history of cardiovascular disease, except for hypertension.
Exclusion criteria
- Detailed medical and social histories will be collected. To allow for ecological validity, participants will not be excluded for use of menopausal hormone therapy or medications affecting cardiovascular function so long as they have been on a consistent regimen for ≥3 months and during the study period. This approach to medications is consistent with recent work in this area.
- Participants will be screened for contraindications to inspiratory muscle strength training including, a history of spontaneous pneumothorax, collapsed lung that has not healed fully, a perforated eardrum that has not healed fully, and/or any other condition of the eardrum.
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Rochester | Minnesota | Mayo Clinic in Rochester | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2025-03-27
- Primary completion: 2027-01-01
- Last update posted: 2026-03-30
- First posted: 2024-12-19
Sponsor & contact
Lead sponsor: Mayo Clinic (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Change in blood pressure (Baseline, 6 weeks)
Measured in millimeters of mercury (mm Hg) - Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency (Baseline, 6 weeks)
Measured by microneurography reported in burst per minute - Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence (Baseline, 6 weeks)
Number of bursts recorded via microneurography
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06743269 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.