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NCT Number: NCT06743269

Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving 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.

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Key information

Conditions

Menopause Blood Pressure Regulation Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

Low-Resistance Inspiratory Muscle Strength Training

Behavioral

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

POWERbreathe K3 device

Device

Inspiratory muscle training device

Primary outcomes

  1. Change in blood pressure

    Time frame: Baseline, 6 weeks

    Measured in millimeters of mercury (mm Hg)

  2. Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency

    Time frame: Baseline, 6 weeks

    Measured by microneurography reported in burst per minute

  3. Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence

    Time frame: Baseline, 6 weeks

    Number of bursts recorded via microneurography

Secondary outcomes

  1. Change in Hot Flash Frequency

    Time frame: Baseline, 6 weeks

    Number of hot flashes indicated through self-reporting

  2. Chang in sleep duration

    Time frame: Baseline, 6 weeks

    Measured by actigraphy data defined as recorded number of minutes in sleep

  3. Change in wake after sleep onset

    Time frame: Baseline, 6 weeks

    Measured by actigraphy data defined as number of minutes from sleep onset to waking

  4. Change in Pittsburgh Sleep Quality Index

    Time frame: Baseline, 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Meyer

CONTACT

[email protected]

507-255-0913

Pamela Engrav

CONTACT

[email protected]

(507) 255-6938

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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