NCT06743269NARecruitingAccepts Healthy Volunteers
Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving Sleep in Midlife Women
Mayo Clinic
Start Date
3/27/2025
Completion Date
1/1/2027
Summary
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.
Eligibility Criteria
Age Range: 45 years to 60 years
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.).
Interventions
BEHAVIORAL
High-Resistance Inspiratory Muscle Strength Training
BEHAVIORAL
Low-Resistance Inspiratory Muscle Strength Training
DEVICE
POWERbreathe K3 device
Conditions
MenopauseHot FlashesBlood Pressure Regulation
Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States