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Search / Trial NCT06743269

Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training

Launched by MAYO CLINIC · Dec 16, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Menopause Blood Pressure Inspiratory Training Hot Flashes

ClinConnect Summary

This clinical trial is exploring how training the muscles we use to breathe can help midlife women who experience hot flashes, sleep problems, and issues with their body's sympathetic nervous system, which affects stress and blood pressure. The researchers want to see if this breathing muscle training can improve these symptoms during menopause.

To participate, women aged 45 to 60 who have hot flashes and live in or near Rochester, MN, can apply. Participants should not smoke, should have a body mass index (BMI) under 40, and should not have a history of heart disease, except for high blood pressure. If you join the study, you can expect to engage in training exercises focused on your breathing muscles over a certain period. It's also important to know that using menopausal hormone therapy or certain medications won't automatically exclude you from the trial, as long as you've been on a stable treatment plan for at least three months.

Gender

FEMALE

Eligibility criteria

  • 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.
  • Additional exclusion criteria will include the use of sleep aids (i.e., prescription, melatonin, doxylamine, valerian root, etc.).

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Sarah Baker, PhD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported