Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT05872035
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2023-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Smartphone Enabled Hearing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'htclinicalquestions@apple.com', 'phone': '8669055303', 'title': 'Rajiv Kumar, MD', 'organization': 'Apple'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were evaluated by the PI and/or designee(s) at each of the three scheduled clinic visits from the time they signed the ICF until they completed the study (approximately 18-31 days after enrollment).', 'eventGroups': [{'id': 'EG000', 'title': 'Self-Fit Settings', 'description': 'Amplification settings established by algorithm and further adjusted by participants per their preference\n\nApple Software: Amplification settings established by algorithm and further adjusted by participants per their preference', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pro-Fit Settings', 'description': 'Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice\n\nby Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Chest Pain', 'notes': 'Unspecified chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pain in Extremity', 'notes': 'Painful left arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-Fit Settings', 'description': 'Amplification settings established by algorithm and further adjusted by participants per their preference\n\nApple Software: Amplification settings established by algorithm and further adjusted by participants per their preference'}, {'id': 'OG001', 'title': 'Pro-Fit Settings', 'description': 'Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice\n\nby Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '26.6', 'spread': '3.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 18-31 days upon enrollment', 'description': 'The IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self-Fit Settings', 'description': 'Amplification settings established by algorithm and further adjusted by participants per their preference\n\nApple Software: Amplification settings established by algorithm and further adjusted by participants per their preference'}, {'id': 'FG001', 'title': 'Pro-Fit Settings', 'description': 'Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice\n\nby Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from multiple sites where audiological services were provided.', 'preAssignmentDetails': 'All 118 enrolled participants were randomized into the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Self-Fit Settings', 'description': 'Amplification settings established by algorithm and further adjusted by participants per their preference\n\nApple Software: Amplification settings established by algorithm and further adjusted by participants per their preference'}, {'id': 'BG001', 'title': 'Pro-Fit Settings', 'description': 'Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice\n\nby Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex at Birth', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Geographical Region of Recruitment and Enrollment', 'unitOfMeasure': 'Participants'}, {'title': 'Subject Medical History with >10.0% Occurrence', 'classes': [{'title': 'Deafness bilateral', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Hypoacusis', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Tinnitus', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical history affecting at least 10% of study participants in any treatment group', 'unitOfMeasure': 'Participants'}, {'title': 'Four-Frequency Pure Tone Average Results-Full Analysis Set', 'classes': [{'categories': [{'title': '15-25 dB HL (No Impairment)', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '26-40 dB HL (Mild Impairment)', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': '41-60 dB HL (Moderate Impairment)', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Classification of the reference audiometry values averaged across four frequencies (0.5, 1, 2, and 4 kHz)', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-24', 'size': 1737863, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-27T13:41', 'hasProtocol': True}, {'date': '2023-08-29', 'size': 721818, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-27T13:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2024-08-09', 'completionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2023-04-26', 'resultsFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2023-05-15', 'dispFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-28', 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results', 'timeFrame': 'Approximately 18-31 days upon enrollment', 'description': 'The IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing']}, 'descriptionModule': {'briefSummary': 'Validation of non-inferiority between headphone amplification settings determined by a participant and settings established by audiologist best practices in individuals 18 years or older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Proficient in written and spoken English, defined by self-report\n* Mild- to moderate- hearing loss as measured by pure tone audiometry (PTA) reference test, or self-report of perceived hearing loss and 15-25 dB HL (by 4PTA)\n* Participants have access to stable internet connection\n\nExclusion Criteria:\n\n* Ear anatomy non-conducive to comfortable wear of headphone\n* Active ear disease\n* Cerumen impaction that cannot be removed\n* Sudden loss of hearing (in the preceding 90 days), defined by self-report\n* Self Report of loud environmental sound exposure (e.g., concert; construction site; fireworks) without hearing protection within 72 hours of reference PTA assessed at Clinic Visit 1\n* Tinnitus that impacts one's daily life, defined by self-report\n* Use of cochlear implants\n* Self-reported issues with small or confined spaces such as a single-person enclosed booth, and/or claustrophobia\n* Health technology, fitness, media outlet employees (or spouse of employees), or employees of CRO/sites contracted to execute this study\n* User noted preference to not wear headphone consistently, or charge headphone and smartphone consistently, during field-use\n* Hearing loss \\>60 dB HL at 0.25-3kHz and \\>65 dB HL at 4kHz in either ear; assessed during PTA\n* Hearing loss that requires electroacoustic settings which are not acoustically stable in the participant's ear per audiologist judgement\n* Current regular use of hearing aids\n* Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region\n* Active treatment, or treatment in the past 6 months, with parenteral aminoglycoside antibiotics\n* In the Investigator's opinion, unable to adhere to study procedures"}, 'identificationModule': {'nctId': 'NCT05872035', 'briefTitle': 'Smartphone Enabled Hearing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apple Inc.'}, 'officialTitle': 'Smartphone Enabled Hearing Study', 'orgStudyIdInfo': {'id': '099-37012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-Fit Settings', 'description': 'Amplification settings established by algorithm and further adjusted by participants per their preference', 'interventionNames': ['Device: Apple Software']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pro-Fit Settings', 'description': 'Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice', 'interventionNames': ['Device: by Audiologist']}], 'interventions': [{'name': 'Apple Software', 'type': 'DEVICE', 'description': 'Amplification settings established by algorithm and further adjusted by participants per their preference', 'armGroupLabels': ['Self-Fit Settings']}, {'name': 'by Audiologist', 'type': 'DEVICE', 'description': 'Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice', 'armGroupLabels': ['Pro-Fit Settings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'IQVIA', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apple Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Iqvia Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}