← Back to Search

Behavioral Intervention

Inspiratory Muscle Training for Menopausal Hot Flashes

Rochester, MN
N/A
Waitlist Available
Led By Sarah Baker, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of cardiovascular disease, except for hypertension
Be between 18 and 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see how training the muscles used for breathing can impact menopausal hot flashes, nerve activity, and sleep in women.

See full description
Who is the study for?
This trial is for midlife women experiencing menopausal hot flashes, with or without hypertension. Participants should be interested in trying a breathing exercise program using the POWERbreathe K3 device to potentially improve their symptoms.Check my eligibility
What is being tested?
The study tests if strengthening the muscles used for breathing can help reduce hot flashes, affect nerve activity related to stress response, and improve sleep quality in menopausal women. It compares high-resistance against low-resistance training.See study design
What are the potential side effects?
Possible side effects may include discomfort from using the POWERbreathe K3 device, such as muscle soreness similar to what one might feel after starting new exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have no heart disease history, except for high blood pressure.
 show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have a history of lung collapse, unhealed perforated eardrum, or similar conditions.
 show original

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency
Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence
Change in blood pressure
Secondary study objectives
Chang in sleep duration
Change in Hot Flash Frequency
Change in Pittsburgh Sleep Quality Index
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High-Resistance Inspiratory Muscle Strength Training GroupExperimental Treatment2 Interventions
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 II: Low-Resistance Inspiratory Muscle Strength Training GroupActive Control2 Interventions
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.

Find a Location

Closest Location:Mayo Clinic in Rochester· Rochester, MN

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,391 Previous Clinical Trials
3,204,662 Total Patients Enrolled
11 Trials studying Hot Flashes
640 Patients Enrolled for Hot Flashes
Sarah Baker, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Hot Flashes
120 Patients Enrolled for Hot Flashes
~20 spots leftby Jan 2027