Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT06743269
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2024-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Measured in millimeters of mercury (mm Hg)'}, {'measure': 'Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Measured by microneurography reported in burst per minute'}, {'measure': 'Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Number of bursts recorded via microneurography'}], 'secondaryOutcomes': [{'measure': 'Change in Hot Flash Frequency', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Number of hot flashes indicated through self-reporting'}, {'measure': 'Chang in sleep duration', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Measured by actigraphy data defined as recorded number of minutes in sleep'}, {'measure': 'Change in wake after sleep onset', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Measured by actigraphy data defined as number of minutes from sleep onset to waking'}, {'measure': 'Change in Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline, 6 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menopause', 'blood pressure', 'inspiratory training', 'hot flashes'], 'conditions': ['Menopause', 'Hot Flashes', 'Blood Pressure Regulation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females aged 45-60 with hot flashes.\n* Participants will be recruited from Rochester, MN and surrounding areas.\n* Non-smokers.\n* BMI \\< 40kg/m\\^2.\n* No history of cardiovascular disease, except for hypertension.\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* Additional exclusion criteria will include the use of sleep aids (i.e., prescription, melatonin, doxylamine, valerian root, etc.).'}, 'identificationModule': {'nctId': 'NCT06743269', 'briefTitle': 'Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Time-efficient Inspiratory Muscle Strength Training for Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women', 'orgStudyIdInfo': {'id': '23-011042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Resistance Inspiratory Muscle Strength Training Group', 'description': '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.', 'interventionNames': ['Behavioral: High-Resistance Inspiratory Muscle Strength Training', 'Device: POWERbreathe K3 device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-Resistance Inspiratory Muscle Strength Training Group', 'description': '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.', 'interventionNames': ['Behavioral: Low-Resistance Inspiratory Muscle Strength Training', 'Device: POWERbreathe K3 device']}], 'interventions': [{'name': 'High-Resistance Inspiratory Muscle Strength Training', 'type': 'BEHAVIORAL', 'description': 'Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6.', 'armGroupLabels': ['High-Resistance Inspiratory Muscle Strength Training Group']}, {'name': 'Low-Resistance Inspiratory Muscle Strength Training', 'type': 'BEHAVIORAL', 'description': 'Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.', 'armGroupLabels': ['Low-Resistance Inspiratory Muscle Strength Training Group']}, {'name': 'POWERbreathe K3 device', 'type': 'DEVICE', 'description': 'Inspiratory muscle training device', 'armGroupLabels': ['High-Resistance Inspiratory Muscle Strength Training Group', 'Low-Resistance Inspiratory Muscle Strength Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Pamela Engrav', 'role': 'CONTACT', 'email': 'engrav.pamela@mayo.edu', 'phone': '(507) 255-6938'}, {'name': 'Nancy Meyer', 'role': 'CONTACT', 'email': 'meyer.nancy2@mayo.edu', 'phone': '507-255-0913'}], 'overallOfficials': [{'name': 'Sarah Baker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah E. Baker, Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}