Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT05265260
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cltd-prs-admin@cochlear.com', 'phone': '+61 2 9428 6555', 'title': 'PRS Specialist, Clinical Affairs', 'organization': 'Cochlear'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Deaths, serious adverse events and non-serious adverse events were not assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Adults Using Currently a Nucleus Cochlear Implant', 'description': 'Adults (\\>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Score of the French MBAA2 Sentence Recognition Test in Quiet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Using Currently a Nucleus Cochlear Implant', 'description': 'Adults (\\>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.'}], 'classes': [{'title': 'Good performer', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Bad performer', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month post activation', 'description': 'Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of \\<90/100 correct sentence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adults Using Currently a Nucleus Cochlear Implant', 'description': 'Adults (\\>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '32 participants were recruited between 21 April 2022 and 24 August 2022. The aim was to recruit 30 participants with data for the primary endpoint. As it was noted during the data collection period that data was missing, the number was increased to 32.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adults Using Currently a Nucleus Cochlear Implant', 'description': 'Adults (\\>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '13.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex/ gender information has not been collected.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race information has not been collected.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-20', 'size': 1442557, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-10T04:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2022-02-23', 'resultsFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-10', 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of the French MBAA2 Sentence Recognition Test in Quiet', 'timeFrame': '1 month post activation', 'description': 'Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of \\<90/100 correct sentence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cochlear implant', 'Sentence recognition', 'Cognitive processing', 'Electrophysiology'], 'conditions': ['Sensorineural Hearing Loss, Bilateral']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Cochlear Implants recipients who are using currently a Nucleus cochlear implant with moderately severe to profound bilateral sensorineural hearing loss.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects, 18 years or older\n* Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.\n* Subjects who have been implanted between January 2016 and December 2021.\n* Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 off-the-ear types.\n* Subjects who are fluent in French (language used in the questionnaire and speech tests)\n* Subjects who are not opposed to participating in the study\n* Subjects for who the medical record data is available throughout the defined data search period.\n\nExclusion Criteria:\n\n* Subjects with single-sided deafness (SSD).\n* Subjects who are not affiliated to the French Social Security.\n* Subjects who are under legal protection.'}, 'identificationModule': {'nctId': 'NCT05265260', 'acronym': 'PROGRESS', 'briefTitle': 'Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study', 'orgStudyIdInfo': {'id': 'EMEA5798'}}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Mathieu Marx, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Pierre-Paul Riquet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EVAMED', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}