Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 4:35 PM
Study NCT ID:
NCT06261034
Status:
RECRUITING
Last Update Posted:
2024-12-31
First Post:
2024-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Sex Differences in Neurocirculatory Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cerebral autoregulation', 'timeFrame': 'Baseline', 'description': 'Measured by transcranial doppler ultrasound (cm/sec).'}, {'measure': 'Sympathetic action potentials per burst', 'timeFrame': 'Baseline', 'description': 'Measured by Microneurography reported as action potentials per burst (reflecting firing rate).'}, {'measure': 'Sympathetic action potential clusters per burst', 'timeFrame': 'Baseline', 'description': 'Measured by Microneurography reported as clusters per burst (reflecting recruitment of latent subpopulations).'}, {'measure': 'Sympathetic action potential conduction latency of each cluster', 'timeFrame': 'Baseline', 'description': 'Measured by Microneurography reported as conduction latency of each cluster (reflecting synaptic delays and verifying larger amplitude clusters as new populations).'}, {'measure': 'Immune function', 'timeFrame': 'Baseline', 'description': 'Immune function will be measured as percent of parent cell population.'}, {'measure': 'Urinary Extracellular Vesicle Presence and Content', 'timeFrame': 'Baseline', 'description': 'Number of extracellular vesicles present in a 24 hour urine collection and the contents being carried by those vesicles.'}, {'measure': 'Plasma Extracellular Vesicle Presence and Content', 'timeFrame': 'Baseline', 'description': 'Number of extracellular vesicles present in blood plasma sample and the contents being carried by those vesicles.'}], 'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Baseline', 'description': 'Measured in millimeters of mercury (mmHg).'}, {'measure': 'Arterial stiffness', 'timeFrame': 'Baseline', 'description': 'Measured by applanation tonometry reported as aortic pulse wave velocity (m/sec)'}, {'measure': 'Endothelial function', 'timeFrame': 'Baseline', 'description': 'Ultrasound assessment of flow-mediated vasodilation of the brachial artery. Brachial artery diameter and blood velocity will be measured after deflation to measure endothelial function.'}], 'secondaryOutcomes': [{'measure': 'Sympathetic nerve burst frequency', 'timeFrame': 'Baseline', 'description': 'Measured by Microneurography reported as number of nerve bursts per minute (burst/min)'}, {'measure': 'Sympathetic nerve burst incidence', 'timeFrame': 'Baseline', 'description': 'Measured by Microneurography reported as number of nerve burst per 100 heart beats (burst/100 heart beats)'}, {'measure': 'Sympathetic nerve burst amplitude (AU)', 'timeFrame': 'Baseline', 'description': 'Measured by Microneurography reported in arbitrary units (AU)'}, {'measure': 'Total muscle sympathetic nerve activity (MSNA)', 'timeFrame': 'Baseline', 'description': 'Measured by Microneurography reported burst arbitrary units per minute (AU/min)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate potential sex differences in neurocirculatory control of blood pressure in patients with untreated obstructive sleep apnea (OSA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with or without untreated obstructive sleep apnea will be recruited from Mayo Clinic in Rochester, MN.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-70 years of age\n\nExclusion Criteria:\n\n* Coronary artery disease\n* Heart failure\n* Pregnancy\n* COPD\n* Diabetes\n* CKD\n* Sleep disorders other than OSA\n* Shift workers\n* Individuals who typically go to sleep after midnight\n* Individuals who traveled across ≥2 time zones within one week of study visits\n* BMI ≥40.0kg/m2\n* Use of nicotine-containing products within the two years preceding study visits\n* Use of allopurinol, proton pump inhibitors, or other medications/supplements which interfere with outcome measures'}, 'identificationModule': {'nctId': 'NCT06261034', 'briefTitle': 'A Study of Sex Differences in Neurocirculatory Control', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Sex Differences in Neurocirculatory Control With Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '23-008765'}, 'secondaryIdInfos': [{'id': '8K12AR084222-15', 'link': 'https://reporter.nih.gov/quickSearch/8K12AR084222-15', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Bock, PhD', 'role': 'CONTACT', 'email': 'bock.joshua@mayo.edu', 'phone': '507-422-0768'}, {'name': 'Ian Greenlund, PhD', 'role': 'CONTACT', 'email': 'Greenlund.Ian@mayo.edu', 'phone': '(507) 422-3411'}, {'name': 'Joshua Bock, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Joshua Bock, PhD', 'role': 'CONTACT', 'email': 'Bock.Joshua@mayo.edu', 'phone': '(507) 422-0768'}, {'name': 'Ian Greenlund, PhD', 'role': 'CONTACT', 'email': 'Greenlund.Ian@mayo.edu', 'phone': '(507) 422-3411'}], 'overallOfficials': [{'name': 'Joshua Bock, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joshua M. Bock', 'investigatorAffiliation': 'Mayo Clinic'}}}}