Recruiting NCT06743269
Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving Sleep in Midlife Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Resistance Inspiratory Muscle Strength Training, Low-Resistance Inspiratory Muscle Strength Training, POWERbreathe K3 device.
- Who it may be relevant to
- Registry conditions: Menopause, Hot Flashes, Blood Pressure Regulation. Basic parameters: 45 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral High-Resistance Inspiratory Muscle Strength Training
Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6. - Behavioral Low-Resistance Inspiratory Muscle Strength Training
Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks. - Device POWERbreathe K3 device
Inspiratory muscle training device
Primary outcome measures
- Change in blood pressure [Time frame: Baseline, 6 weeks]
- Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency [Time frame: Baseline, 6 weeks]
- Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence [Time frame: Baseline, 6 weeks]
Secondary outcome measures (4)
- Change in Hot Flash Frequency [Time frame: Baseline, 6 weeks]
- Chang in sleep duration [Time frame: Baseline, 6 weeks]
- Change in wake after sleep onset [Time frame: Baseline, 6 weeks]
- Change in Pittsburgh Sleep Quality Index [Time frame: Baseline, 6 weeks]
Eligibility 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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06743269 · 23-011042 · 1R21AG101515-01