Breathing muscle training to help midlife women with menopause symptoms
Time-efficient Inspiratory Muscle Strength Training for Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 45 Years to 60 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06743269 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are females aged 45-60 experiencing hot flashes and not having a history of cardiovascular disease, except for hypertension.
Not a fit: Patients with a history of spontaneous pneumothorax, collapsed lung, or those using sleep aids may not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown promise in using inspiratory muscle training for various health benefits.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.