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Recruiting NCT06743269

NCT06743269 Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training

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Clinical Trial Summary
NCT ID NCT06743269
Status Recruiting
Phase
Sponsor Mayo Clinic
Condition Menopause
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2025-03-27
Primary Completion 2027-01-01

Eligibility & Interventions

Sex Female only
Min Age 45 Years
Max Age 60 Years
Study Type INTERVENTIONAL
Interventions
High-Resistance Inspiratory Muscle Strength TrainingLow-Resistance Inspiratory Muscle Strength TrainingPOWERbreathe K3 device

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2025-03-27 with a primary completion date of 2027-01-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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.).

Contact & Investigator

Central Contact

Pamela Engrav

✉ engrav.pamela@mayo.edu

📞 (507) 255-6938

Principal Investigator

Sarah Baker, PhD

PRINCIPAL INVESTIGATOR

Mayo Clinic

Frequently Asked Questions

Who can join the NCT06743269 clinical trial?

This trial is open to female participants only, aged 45 Years or older, up to 60 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06743269 currently recruiting?

Yes, NCT06743269 is actively recruiting participants. Contact the research team at engrav.pamela@mayo.edu for enrollment information.

Where is the NCT06743269 trial being conducted?

This trial is being conducted at Rochester, United States.

Who is sponsoring the NCT06743269 clinical trial?

NCT06743269 is sponsored by Mayo Clinic. The principal investigator is Sarah Baker, PhD at Mayo Clinic. The trial plans to enroll 30 participants.

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