Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 1:10 AM
Study NCT ID:
NCT06326866
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2024-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Otoacoustic Emissions in Different Blood Types
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017084', 'term': 'Otoacoustic Emissions, Spontaneous'}], 'ancestors': [{'id': 'D006309', 'term': 'Hearing'}, {'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal to noise ratios', 'timeFrame': '1 month', 'description': 'SNRs obtained for different frequencies in OAE In TEOAE, 1, 1.4, 2, 2.8, 4 kHz, in DPOAE 1, 1.4, 2, 2.8, 4, 6 kHz'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['otoacoustic emissions', 'blood type'], 'conditions': ['Hearing Loss, Cochlear']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds.', 'detailedDescription': 'Many factors have a significant impact on otoacoustic emission (OAE) measurement and quality of analysis. Race, age and gender are among the non-pathological factors. To date there is clear data to demonstrate the association of blood types with OAEs. The aim of our research is to investigate the relation of different blood groups (ABO) and Rh factors on transient evoked OAE and distortion product OAE amplitudes and inner ear potentials, differences between ears and to contribute to the limited literature on cochlear hearing loss susceptibility and blood groups with the hypothesis that blood groups may be associated with hearing thresholds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals between the ages of 18-26 with known blood type without hearing loss', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* not having hearing loss\n* having a blood group card obtained from health institutions\n\nExclusion Criteria:\n\n* not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06326866', 'briefTitle': 'Otoacoustic Emissions in Different Blood Types', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Association of Blood Type Differences and Signal-Noise Ratio in TEOAE and DPAOE in Individuals With Normal Hearing', 'orgStudyIdInfo': {'id': 'E-74555795-050.04-941208'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with A Rh (+) blood group', 'description': 'Individuals with normal hearing and whose blood group was previously determined as A Rh (+) will be included and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed.', 'interventionNames': ['Diagnostic Test: Otoacoustic emissions (non-invasive)']}, {'label': 'Individuals with A Rh (-) blood group', 'description': 'Individuals with normal hearing and whose blood group was previously determined as A Rh (-) will be included and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed.', 'interventionNames': ['Diagnostic Test: Otoacoustic emissions (non-invasive)']}, {'label': 'Individuals with B Rh (+) blood group', 'description': 'Individuals with normal hearing and whose blood group was previously determined as B Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed.', 'interventionNames': ['Diagnostic Test: Otoacoustic emissions (non-invasive)']}, {'label': 'Individuals with B Rh (-) blood group', 'description': 'Individuals with normal hearing and whose blood group was previously determined as B Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed.', 'interventionNames': ['Diagnostic Test: Otoacoustic emissions (non-invasive)']}, {'label': 'Individuals with AB Rh (+) blood group', 'description': 'Individuals with normal hearing and whose blood group was previously determined as AB Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed.', 'interventionNames': ['Diagnostic Test: Otoacoustic emissions (non-invasive)']}, {'label': 'Individuals with AB Rh (-) blood group', 'description': 'Individuals with normal hearing and whose blood group was previously determined as AB Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed.', 'interventionNames': ['Diagnostic Test: Otoacoustic emissions (non-invasive)']}, {'label': 'Individuals with O Rh (+) blood group', 'description': 'Individuals with normal hearing and whose blood group was previously determined as O Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed.', 'interventionNames': ['Diagnostic Test: Otoacoustic emissions (non-invasive)']}, {'label': 'Individuals with O Rh (-) blood group', 'description': 'Individuals with normal hearing and whose blood group was previously determined as O Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed.', 'interventionNames': ['Diagnostic Test: Otoacoustic emissions (non-invasive)']}], 'interventions': [{'name': 'Otoacoustic emissions (non-invasive)', 'type': 'DIAGNOSTIC_TEST', 'description': 'There is no invasive intervention in the study. Individuals with predetermined blood types will be included in the study.', 'armGroupLabels': ['Individuals with A Rh (+) blood group', 'Individuals with A Rh (-) blood group', 'Individuals with AB Rh (+) blood group', 'Individuals with AB Rh (-) blood group', 'Individuals with B Rh (+) blood group', 'Individuals with B Rh (-) blood group', 'Individuals with O Rh (+) blood group', 'Individuals with O Rh (-) blood group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34107', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Eyyup KARA', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Eyyup Kara, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data sharing is planned.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eyyup Kara', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}