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

NCT06743269 | Recruiting

• 1 other identifier: 23-011042
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Hot Flashes; Blood Pressure Regulation

Keywords

menopause; blood pressure; inspiratory training; hot flashes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in Hot Flash Frequency

  Baseline, 6 weeks

• Chang in sleep duration

  Baseline, 6 weeks

• Change in wake after sleep onset

  Baseline, 6 weeks

• Change in Pittsburgh Sleep Quality Index

  Baseline, 6 weeks

Study Arms (2)

High-Resistance Inspiratory Muscle Strength Training Group

EXPERIMENTAL

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

Low-Resistance Inspiratory Muscle Strength Training Group

ACTIVE COMPARATOR

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

Interventions

High-Resistance Inspiratory Muscle Strength Training BEHAVIORAL

Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6.

High-Resistance Inspiratory Muscle Strength Training Group

Low-Resistance Inspiratory Muscle Strength Training BEHAVIORAL

Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.

Low-Resistance Inspiratory Muscle Strength Training Group

POWERbreathe K3 device DEVICE

Inspiratory muscle training device

High-Resistance Inspiratory Muscle Strength Training Group; Low-Resistance Inspiratory Muscle Strength Training Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Baker, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Engrav

CONTACT

(507) 255-6938; engrav.pamela@mayo.edu

Nancy Meyer

CONTACT

507-255-0913; meyer.nancy2@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: March 27, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)