MenopauseNCT06743269
Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving Sleep in Midlife Women
A study testing High-Resistance Inspiratory Muscle Strength Training, Low-Resistance Inspiratory Muscle Strength Training and POWERbreathe K3 device in people with Menopause and Hot Flashes, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hot Flashes, Blood Pressure Regulation
- What is being tested?
- High-Resistance Inspiratory Muscle Strength Training, Low-Resistance Inspiratory Muscle Strength Training and POWERbreathe K3 device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
- Being tested
- High-Resistance Inspiratory Muscle Strength Training, Low-Resistance Inspiratory Muscle Strength Training, POWERbreathe K3 device
- Keywords
- menopause, blood pressure, inspiratory training, hot flashes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Resistance Inspiratory Muscle Strength TrainingBehavioural
Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6.
Low-Resistance Inspiratory Muscle Strength TrainingBehavioural
Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.
POWERbreathe K3 deviceDevice
Inspiratory muscle training device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Low-Resistance Inspiratory Muscle Strength Training; Device: POWERbreathe K3 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured in millimeters of mercury (mm Hg)
Measured: Baseline, 6 weeks
Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency
Measured by microneurography reported in burst per minute
Measured: Baseline, 6 weeks
Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence
Number of bursts recorded via microneurography
Measured: Baseline, 6 weeks
Secondary outcomes (4)
Change in Hot Flash Frequency
Number of hot flashes indicated through self-reporting
Measured: Baseline, 6 weeks
Chang in sleep duration
Measured by actigraphy data defined as recorded number of minutes in sleep
Measured: Baseline, 6 weeks
Change in wake after sleep onset
Measured by actigraphy data defined as number of minutes from sleep onset to waking
Measured: 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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start27 Mar 2025
- Primary completion1 Jan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sarah E. Baker, Ph.D., Mayo Clinic
- Investigators
- Sarah Baker, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743269
- Sponsor's protocol ID
- 23-011042
- Other IDs
- 1R21AG101515-01
- Status last verified
- Jul 2026
- First submitted
- 16 Dec 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving Sleep in Midlife Women
- ClinicalTrials.gov ID
- NCT06743269
- Acronym / sponsor ID
- 23-011042
- Conditions
- Menopause, Hot Flashes, Blood Pressure Regulation
- Keywords
- menopause, blood pressure, inspiratory training, hot flashes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Resistance Inspiratory Muscle Strength Training Group | Experimental | Behavioral: High-Resistance Inspiratory Muscle Strength Training, Device: POWERbreathe K3 deviceSubjects 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. |
| Low-Resistance Inspiratory Muscle Strength Training Group | Active comparator | Behavioral: Low-Resistance Inspiratory Muscle Strength Training, Device: POWERbreathe K3 deviceSubjects 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Resistance Inspiratory Muscle Strength TrainingPerforms inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6. | Behavioural | High-Resistance Inspiratory Muscle Strength Training Group |
| Low-Resistance Inspiratory Muscle Strength TrainingPerforms inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks. | Behavioural | Low-Resistance Inspiratory Muscle Strength Training Group |
| POWERbreathe K3 deviceInspiratory muscle training device | Device | High-Resistance Inspiratory Muscle Strength Training Group, Low-Resistance Inspiratory Muscle Strength Training Group |
Primary outcome
Change in blood pressure
Time frame: Baseline, 6 weeks
Measured in millimeters of mercury (mm Hg)
Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency
Time frame: Baseline, 6 weeks
Measured by microneurography reported in burst per minute
Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence
Time frame: Baseline, 6 weeks
Number of bursts recorded via microneurography
4 secondary outcomes
Change in Hot Flash Frequency
Time frame: Baseline, 6 weeks
Chang in sleep duration
Time frame: Baseline, 6 weeks
Change in wake after sleep onset
Time frame: Baseline, 6 weeks
Change in Pittsburgh Sleep Quality Index
Time frame: Baseline, 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Baker, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Resistance Inspiratory Muscle Strength Training, Low-Resistance Inspiratory Muscle Strength Training and POWERbreathe K3 device in people with Menopause and Hot Flashes, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Engrav ((507) 255-6938, engrav.pamela@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Baseline, 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.