Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT04357704
Status:
WITHDRAWN
Last Update Posted:
2025-08-03
First Post:
2018-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Delay in setting up the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue', 'timeFrame': 'day 0', 'description': 'SRT is used as an outcome measure to quantify the acuity for speech perception in noise with Interaural Time Difference between the two ears. Signal recognition in a background noise is assessed the following conditions S0N0, S0N500, S0N1000, S-500N500 et S0Nuncorr. The noise level is constant at 65 dB SPL, the signal level is modified in the adaptive procedure in order to converge towards a score of 50% of correct response.'}], 'secondaryOutcomes': [{'measure': 'speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners', 'timeFrame': 'day 0', 'description': 'SRT is used as an outcome measure to quantify the acuity for speech perception in noise without Interaural Time Difference between the two ears.'}, {'measure': 'ITD sensitivity in bilateral cochlear implant user', 'timeFrame': 'day 0', 'description': 'Speech signal and noise are presented at 65dB SPL. Participant adjusts the Interaural Time Difference between the speech signal and noise between -1000 and +1000µs. Participant moves the cursor on the interface until he/she hears a difference in sound.'}, {'measure': 'Preferred jitter in bilateral cochlear implant user', 'timeFrame': 'day 0', 'description': 'Speech signal and noise are presented at 65dB SPL. Participant adjusts the jitter of the train pulse timing from 0 to +1000µs to improve the Interaural Time Difference.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iteraural Time Difference'], 'conditions': ['Hearing Loss, Cochlear']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.oticonmedical.com', 'label': 'oticon medical website'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.', 'detailedDescription': 'Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent in local language\n* Normal hearing listener:\n* pure tone threshold \\> 25dB from 125Hz to 12kHz\n* Cochlear implant recipient\n* bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion\n* Digisonic SP® cochlear implants user\n\nExclusion Criteria:\n\n* binaural sensitivity threshold \\< 1000µs'}, 'identificationModule': {'nctId': 'NCT04357704', 'acronym': 'APPIC', 'briefTitle': 'Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oticon Medical'}, 'officialTitle': 'Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.', 'orgStudyIdInfo': {'id': 'PIC_10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bilateral cochlear implant recipients', 'interventionNames': ['Other: S0N0', 'Other: S0N500', 'Other: S-500N500', 'Other: S0N1000', 'Other: S0Nuncorr']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'normal hearing listners', 'interventionNames': ['Other: S0N0', 'Other: S0N500', 'Other: S-500N500', 'Other: S0N1000', 'Other: S0Nuncorr']}], 'interventions': [{'name': 'S0N0', 'type': 'OTHER', 'description': '(no ITD)', 'armGroupLabels': ['bilateral cochlear implant recipients', 'normal hearing listners']}, {'name': 'S0N500', 'type': 'OTHER', 'description': '(ITD +500µs on noise)', 'armGroupLabels': ['bilateral cochlear implant recipients', 'normal hearing listners']}, {'name': 'S-500N500', 'type': 'OTHER', 'description': '(ITD -500µs on signal and +500 µs on noise)', 'armGroupLabels': ['bilateral cochlear implant recipients', 'normal hearing listners']}, {'name': 'S0N1000', 'type': 'OTHER', 'description': '(ITD + 1000 µs on noise)', 'armGroupLabels': ['bilateral cochlear implant recipients', 'normal hearing listners']}, {'name': 'S0Nuncorr', 'type': 'OTHER', 'description': '(no ITD cue, with uncorrelated stimulation frame)', 'armGroupLabels': ['bilateral cochlear implant recipients', 'normal hearing listners']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicolas Guevara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital University Nice-IUFC'}, {'name': 'Alexis Bozorg-Grayeli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital University Dijon-François Mitterrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oticon Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}