Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-01 @ 7:10 PM
Study NCT ID:
NCT05869266
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2023-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tuned App Self-Fitting vs. Professional Fitting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, randomized crossover clinical study comparing two methods of fitting subjects with mild to moderate sensorineural hearing loss with hearing aids. Subjects will receive hearing aids and be assigned to professional-fitting arm or self-fitting arm, use the hearing aids for two weeks then switch to the other arm and use the hearing aids for another two weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of self fitting and professional fitting by COSI scores', 'timeFrame': '4 weeks', 'description': 'To compare the professional fitting and the self fitting using the Tuned App, the scores of Client Oriented Scale of Improvement (COSI) questionnaire will be used.'}], 'secondaryOutcomes': [{'measure': 'Comparison of self fitting and professional fitting by IOI-HA scores', 'timeFrame': '4 weeks', 'description': "To compare the subjects' self-reported outcomes between professional fitting and self fitting using the Tuned App, the scores of the International Outcome Inventory for Hearing Aids (IOI-HA) questionnaires will be used."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['self fitting'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the perceived outcome of the self-fitting performed by the participants using the Tuned mobile application with the traditional professional fitting as performed by a licensed professional audiologist in subjects with mild to moderate sensorineural hearing loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males and females, 18 years and older.\n* Mild to moderate sensorineural hearing loss.\n* Own and able to use a smart phone (Android or iOS).\n* Able to read and understand Hebrew.\n\nExclusion Criteria:\n\n* Conductive mixed hearing loss.\n* Unilateral hearing loss.\n* Any external or inner ear malformations.\n* Symptoms of ear disease or excessive cerumen.'}, 'identificationModule': {'nctId': 'NCT05869266', 'briefTitle': 'Tuned App Self-Fitting vs. Professional Fitting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tuned Ltd.'}, 'officialTitle': 'A Prospective, Crossover Randomized Controlled Trial to Compare Subjective Outcome of a Self-fitting Process Using Tuned App to a Licensed Professional Fitting', 'orgStudyIdInfo': {'id': 'TU1-PLN-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Professional-fitting', 'description': 'Subject receives hearing aids and a licensed professional performs the hearing aid fitting using professional programing tools, and the thresholds that were obtained from the traditional audiometry.\n\nSubject uses the professionally fitted hearing aids for two weeks then completes COSI and the IOI-HA questionnaires.', 'interventionNames': ['Device: professional fitting vs. self fitting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-fitting', 'description': 'Subject receives hearing aids, downloads the Tuned self fitting App and performs self-fitting of the hearing aids including a self-hearing test.\n\nSubject uses the self fitted hearing aids for two weeks then completes COSI and the IOI-HA questionnaires.', 'interventionNames': ['Device: professional fitting vs. self fitting']}], 'interventions': [{'name': 'professional fitting vs. self fitting', 'type': 'DEVICE', 'otherNames': ['Tuned App'], 'description': 'Licensed professional fits the hearing aid fitting using professional programing tools and thresholds obtained from the traditional audiometry vs. subject performs self-fitting of the hearing aids using the Tuned App.', 'armGroupLabels': ['Professional-fitting', 'Self-fitting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Ozen-Kashevet Hearing Clinic', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Leonid Kriksunov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ozen-Kashevet Hearing Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuned Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}