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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06743269
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 60 Years
Healthy Volunteers
Accepted

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.
  • 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

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
Mar 2026
Primary completion
Jan 1, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in blood pressure [ Time Frame: Baseline, 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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