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

NCT ID: NCT06743269

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2027-01-31

Brief Summary

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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

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Conditions

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Menopause Hot Flashes Blood Pressure Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

High-Resistance Inspiratory Muscle Strength Training

Intervention Type 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.

POWERbreathe K3 device

Intervention Type DEVICE

Inspiratory muscle training device

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.

Group Type ACTIVE_COMPARATOR

Low-Resistance Inspiratory Muscle Strength Training

Intervention Type BEHAVIORAL

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

POWERbreathe K3 device

Intervention Type DEVICE

Inspiratory muscle training device

Interventions

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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.

Intervention Type BEHAVIORAL

Low-Resistance Inspiratory Muscle Strength Training

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

Intervention Type BEHAVIORAL

POWERbreathe K3 device

Inspiratory muscle training device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Sarah E. Baker, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Baker, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pamela Engrav

Role: CONTACT

(507) 255-6938

Nancy Meyer

Role: CONTACT

507-255-0913

Other Identifiers

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23-011042

Identifier Type: -

Identifier Source: org_study_id

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