Health TrialsbyHealthPanel

Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving Sleep in Midlife Women

ConditionsMenopauseHot FlashesBlood Pressure Regulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorMayo Clinic

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Females aged 45-60 with hot flashes.

Participants will be recruited from Rochester, MN and surrounding areas.

Non-smokers.

BMI < 40kg/m².

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High-Resistance Inspiratory Muscle Strength Training GroupExperimental treatment 2 interventions
Group B: Low-Resistance Inspiratory Muscle Strength Training GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in blood pressure

Measured in millimeters of mercury (mm Hg)

Time frame
Baseline, 6 weeks
2

Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency

Measured by microneurography reported in burst per minute

Time frame
Baseline, 6 weeks
3

Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence

Number of bursts recorded via microneurography

Time frame
Baseline, 6 weeks

Secondary outcomes

1

Change in Hot Flash Frequency

Number of hot flashes indicated through self-reporting

Time frame
Baseline, 6 weeks
2

Chang in sleep duration

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

Time frame
Baseline, 6 weeks
3

Change in wake after sleep onset

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

Time frame
Baseline, 6 weeks
4

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.

Time frame
Baseline, 6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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