Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT06128161
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2023-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception
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': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PEPS-C speech test battery', 'timeFrame': 'Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions', 'description': 'Test battery of 7 speech tests examining prosodic elements of speech, each section scored out of 16 (112 in total higher scores better outcome)'}], 'secondaryOutcomes': [{'measure': 'AB words speech test', 'timeFrame': 'Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions', 'description': 'Word speech discrimination test in quiet, 30 words presented, scored as % correct, higher score better outcome'}, {'measure': 'SSQ12 Questionnaire', 'timeFrame': 'Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions', 'description': 'Speech Spatial Qualities patient reported outcome measure, scored out of 120 higher scores better outcome'}, {'measure': 'Unaided Soundfield Audiometry', 'timeFrame': 'Tested at one time point at day 1 of study after recruitment', 'description': 'Soundfield hearing test without Cochlear Implant or Hearing Aid'}, {'measure': 'BKB sentences speech test', 'timeFrame': 'Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions', 'description': 'Sentences speech discrimination test in quiet, 100 words presented, 50 male, 50 female voice, scored as %'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cochlear Hearing Loss']}, 'descriptionModule': {'briefSummary': 'An observational study to determine and assess perception of prosodic information in adults who use bimodal stimulation (cochlear implant plus hearing aid) when using both devices vs. cochlear implant alone.', 'detailedDescription': 'People with severe to profound hearing loss often do not get satisfactory benefit from their hearing aids. A cochlear implant (CI) is a prosthetic device for the inner ear which can directly stimulate the auditory nerve, bypassing damaged inner ear hair cells and thus provide audible sensations to profoundly deaf patients.\n\nCurrently, one CI is funded by NHS England for adult patients and the eligibility criteria for implantation has been relaxed in recent years. As a result, there are now an increasing number of unilateral CI users who possess low-frequency residual hearing in their non-implanted ear. For many patients this residual hearing may still be usefully amplified by a HA. This configuration, consisting of a CI and a contralateral HA, is known as bimodal stimulation.\n\nThe PEPS-C receptive test battery has been previously used to assess prosody perception in hearing loss.\n\nThe current project will use selected tests from the PEPS-C prosodic test battery to assess intonation, emotion and phrase stress perception ability in adults with bimodal stimulation using both devices together and CI alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients at St. Thomas' Hearing Implant Centre", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Has unilateral Cochlear Implant\n* Consistent use of Hearing Aid\n* Obtains some benefit in speech discrimination from hearing aid (\\> 20% AB words)\n* Post-lingually deafened\n* Fluent English\n\nExclusion Criteria:\n\n* Longstanding significant asymmetry (\\> 20 dB HL 4 frequency average) in hearing where the unimplanted ear is the worse ear\n* Inconsistent Hearing Aid use\n* Significant conductive hearing loss (\\> 20 dB HL 4 frequency average)\n* Using Electro-Acoustic stimulation Cochlear Implant\n* Aetiology of hearing loss likely associated with auditory neuropathy\n* Significantly abnormal appearance of cochlea or cochlear nerve'}, 'identificationModule': {'nctId': 'NCT06128161', 'briefTitle': 'Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception', 'orgStudyIdInfo': {'id': '307417'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hearing Aid', 'type': 'DEVICE', 'description': 'Contralateral Hearing Aid to Cochlear Implant'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St. Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}