Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT04565158
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep in Women With Bilateral Salpingo-Oophorectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'exploratory correlation between sleep measures and cognitive function', 'timeFrame': '2 years', 'description': 'correlation between objective and subjective sleep measures (sleep duration, sleep quality and sleep disorders) and tests of cognitive function (attention, memory, language, and global cognitive function)'}, {'measure': 'exploratory correlation between sleep measures and neuroimaging', 'timeFrame': '2 years', 'description': 'correlation between objective and subjective sleep measures (sleep duration, sleep quality and sleep disorders) and tests of cognitive function (attention, memory, language, and global cognitive function)'}], 'primaryOutcomes': [{'measure': 'prevalence of sleep disorders', 'timeFrame': '2 years', 'description': 'prevalence of sleep disordered breathing, insomnia, and restless legs syndrome'}, {'measure': 'prevalence of short sleep duration', 'timeFrame': '2 years', 'description': 'objective sleep duration from actigraphy/polysomnography and subjective sleep duration from self-report'}, {'measure': 'prevalence of poor sleep quality', 'timeFrame': '2 years', 'description': 'objective sleep quality from actigraphy/polysomnography and subjective sleep quality from self-report'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['salpingo-oophorectomy', 'sleep', 'cognitive decline'], 'conditions': ['Bilateral Salpingo-oophorectomy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is the compare objective and subjective sleep characteristics in women who have undergone removal of both ovaries (bilateral salpingo-oophorectomy) before natural menopause compared to women who did not undergo this procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases: Women who underwent bilateral salpingo-oophorectomy prior to natural menopause Controls: Women who did not undergo bilateral salpingo-oophorectomy prior to natural menopause', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who participate in the parent SCORE studies (NCT03821857)\n\nExclusion Criteria:\n\n* Night shift workers will be excluded'}, 'identificationModule': {'nctId': 'NCT04565158', 'briefTitle': 'Sleep in Women With Bilateral Salpingo-Oophorectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Assessment of Sleep Disruption in Women With Bilateral Salpingo-Oophorectomy - A SCORE Ancillary Study', 'orgStudyIdInfo': {'id': '20-005982'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with bilateral salpingo-oophorectomy (BSO)'}, {'label': 'Women without bilateral salpingo-oophorectomy (BSO)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Naima Covassin, 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': 'Naima Covassin', 'investigatorAffiliation': 'Mayo Clinic'}}}}