Breathing muscle training to help midlife women with menopause symptoms
Official title: Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving Sleep in Midlife Women
Run by Mayo Clinic · NCT06743269 · Data updated 2026-11-12
This study is testing if breathing exercises can help women aged 45-60 feel better during menopause by reducing hot flashes and improving sleep quality.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 60 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | March 27, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | January 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT06743269 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females aged 45-60 experiencing hot flashes and not having a history of cardiovascular disease, except for hypertension.
✕Probably not a fit
Patients with a history of spontaneous pneumothorax, collapsed lung, or those using sleep aids may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of inspiratory muscle strength training on menopausal symptoms such as hot flashes, sympathetic nerve activity, and sleep quality in women aged 45-60. Participants will engage in either high-resistance or low-resistance breathing exercises using the POWERbreathe K3 device. The research aims to determine if strengthening the muscles used for inhalation can improve these symptoms and overall well-being. The study will recruit non-smoking women from Rochester, MN, and surrounding areas who meet specific health criteria.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate menopausal symptoms and improve sleep quality for midlife women.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in using inspiratory muscle training for various health benefits.
Who can join: the full rules
Show full inclusion / exclusion 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.).
Where it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Sarah Baker, PhD — Mayo Clinic
- Study coordinator: Pamela Engrav
- Email: engrav.pamela@mayo.edu
- Phone: (507) 255-6938
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.