Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training

Not Applicable

Recruiting

• Conditions: Menopause; Hot Flashes; Blood Pressure Regulation

• Registration Number: NCT06743269
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Study Start: 2025-03-27
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline, 6 weeks	Measured in millimeters of mercury (mm Hg)
Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency	Baseline, 6 weeks	Measured by microneurography reported in burst per minute
Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence	Baseline, 6 weeks	Number of bursts recorded via microneurography

Secondary Outcome Measures

Name	Time	Method
Change in Hot Flash Frequency	Baseline, 6 weeks	Number of hot flashes indicated through self-reporting
Chang in sleep duration	Baseline, 6 weeks	Measured by actigraphy data defined as recorded number of minutes in sleep
Change in wake after sleep onset	Baseline, 6 weeks	Measured by actigraphy data defined as number of minutes from sleep onset to waking
Change in Pittsburgh Sleep Quality Index	Baseline, 6 weeks	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States