An interventional study of High-Resistance Inspiratory Muscle Strength Training and Low-Resistance Inspiratory Muscle Strength Training in Menopause, Hot Flashes and Blood Pressure Regulation, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science
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.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will partake in 5 sets of 6 inspiratory maneuvers (total: 30 maneuvers/session) 6 days a week for 6 weeks using the POWERbreathe K3 device to monitor adherence.
Behavioral: High-Resistance Inspiratory Muscle Strength Training · Device: POWERbreathe K3 device
Subjects will partake in 5 sets of 6 inspiratory maneuvers (total: 30 maneuvers/session) 6 days a week for 6 weeks using the POWERbreathe K3 device to monitor adherence.
Behavioral: Low-Resistance Inspiratory Muscle Strength Training · Device: POWERbreathe K3 device
Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6.
Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.
Inspiratory muscle training device
Change in blood pressure
Measured in millimeters of mercury (mm Hg)
Time frame: Baseline, 6 weeks
Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency
Measured by microneurography reported in burst per minute
Time frame: Baseline, 6 weeks
Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence
Number of bursts recorded via microneurography
Time frame: Baseline, 6 weeks
Change in Hot Flash Frequency
Number of hot flashes indicated through self-reporting
Time frame: Baseline, 6 weeks
Chang in sleep duration
Measured by actigraphy data defined as recorded number of minutes in sleep
Time frame: Baseline, 6 weeks
Change in wake after sleep onset
Measured by actigraphy data defined as number of minutes from sleep onset to waking
Time frame: Baseline, 6 weeks
Change in Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Time frame: Baseline, 6 weeks
Plan to share: No
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