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

Time-efficient Inspiratory Muscle Strength Training for Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women

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.

Study Overview

• Status: Recruiting
• Conditions: Hot Flashes; Menopause; Blood Pressure Regulation
• Intervention / Treatment: Behavioral: High-Resistance Inspiratory Muscle Strength Training; Device: POWERbreathe K3 device; Behavioral: Low-Resistance Inspiratory Muscle Strength Training

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pamela Engrav; Phone Number: (507) 255-6938; Email: engrav.pamela@mayo.edu
• Study Contact Backup: Name: Nancy Meyer; Phone Number: 507-255-0913; Email: meyer.nancy2@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Resistance Inspiratory Muscle Strength Training Group; 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; Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6.; Device: POWERbreathe K3 device; Inspiratory muscle training device
Active Comparator: Low-Resistance Inspiratory Muscle Strength Training Group; 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.	Device: POWERbreathe K3 device; Inspiratory muscle training device; Behavioral: Low-Resistance Inspiratory Muscle Strength Training; Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hot Flash Frequency	Number of hot flashes indicated through self-reporting	Baseline, 6 weeks
Chang in sleep duration	Measured by actigraphy data defined as recorded number of minutes in sleep	Baseline, 6 weeks
Change in wake after sleep onset	Measured by actigraphy data defined as number of minutes from sleep onset to waking	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.	Baseline, 6 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Sarah Baker, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: menopause; blood pressure; hot flashes; inspiratory training
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hot Flashes
• Other Study ID Numbers: 23-011042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No