Actively Recruiting
Time-efficient Inspiratory Muscle Strength Training for Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women
Led by Mayo Clinic · Updated on 2026-03-30
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how training the muscles used for breathing in (inspiratory muscles) affects menopausal hot flashes, sympathetic nerve activity, and sleep quality in women aged 45 to 60. The study focuses on midlife women experiencing hot flashes and explores how this targeted muscle training may influence blood pressure and nerve activity related to menopause. Participants will be randomly assigned to one of two groups: a high-resistance inspiratory muscle strength training group or a low-resistance group. Both groups will perform 5 sets of 6 inhalation maneuvers (30 maneuvers per session), 6 days a week, for 6 weeks using the POWERbreathe K3 device, which also tracks adherence. The high-resistance group gradually increases effort from 55% to 75% of maximal inspiratory pressure over the weeks, while the low-resistance group maintains a constant 15% effort. During the study, participants will be monitored at baseline and after 6 weeks for changes in blood pressure, muscle sympathetic nerve activity, hot flash frequency, sleep duration, and sleep quality using questionnaires and physiological measures. The study uses the POWERbreathe K3 device to ensure participants follow the training schedule. Overall participation will last for 6 weeks, with assessments conducted before and after the training period to evaluate the effects on menopause-related symptoms and nervous system activity.
CONDITIONS
Brief Title
Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 45 to 60 years
- Experiencing hot flashes
- Non-smoker
- Body mass index (BMI) less than 40 kg/m²
- No history of cardiovascular disease except for hypertension
- Participants recruited from Rochester, MN and surrounding areas
You will not qualify if you...
- History of spontaneous pneumothorax or unhealed collapsed lung
- Unhealed perforated eardrum or other ear conditions
- Use of sleep aids such as prescription medications, melatonin, doxylamine, or valerian root
- Use of menopausal hormone therapy or cardiovascular medications if not on a stable regimen for at least 3 months
- Detailed medical and social histories collected to identify contraindications to inspiratory muscle training
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants perform inspiratory muscle strength training using the POWERbreathe K3 device, completing 5 sets of 6 inspiratory maneuvers (total 30 maneuvers) 6 days a week for 6 weeks at varying resistance levels depending on group assignment.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
P
Pamela Engrav
N
Nancy Meyer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here