Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 7:35 AM
Study NCT ID:
NCT03866850
Status:
TERMINATED
Last Update Posted:
2023-04-07
First Post:
2019-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Degenerative Consequences of Congenital Deafness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-03', 'releaseDate': '2024-04-30'}, {'resetDate': '2025-03-04', 'releaseDate': '2025-02-24'}, {'resetDate': '2025-03-24', 'releaseDate': '2025-03-13'}, {'resetDate': '2025-04-22', 'releaseDate': '2025-04-03'}, {'resetDate': '2025-08-01', 'releaseDate': '2025-07-15'}, {'resetDate': '2025-10-06', 'releaseDate': '2025-09-19'}], 'estimatedResultsFirstSubmitDate': '2024-04-30'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI passed away. Ending grant and closing lab.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slope of the strength duration function', 'timeFrame': 'starting 6 months post award notice and will take up to 4 years to complete', 'description': 'Subjects will be measured for detection thresholds as a function of phase duration of the pulse train and the slope of the function will be derived.'}], 'secondaryOutcomes': [{'measure': 'Psychophysically estimated neural excitation width', 'timeFrame': 'starting 6 months post award notice and will take up to 4 years to complete', 'description': 'Subjects will be measured for psychophysical forward-masked spatial tuning curves using stimuli with long and short phase duration.'}, {'measure': 'Speech recognition using long phase duration', 'timeFrame': 'starting 6 months post award notice and will take up to 4 years to complete', 'description': "Subjects' speech recognition performance will be evaluated using CUNY and TIMIT sentences with long and short phase duration stimulation."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Deafness']}, 'referencesModule': {'references': [{'pmid': '23462803', 'type': 'BACKGROUND', 'citation': 'Hancock KE, Chung Y, Delgutte B. Congenital and prolonged adult-onset deafness cause distinct degradations in neural ITD coding with bilateral cochlear implants. J Assoc Res Otolaryngol. 2013 Jun;14(3):393-411. doi: 10.1007/s10162-013-0380-5. Epub 2013 Mar 5.'}, {'pmid': '20962228', 'type': 'BACKGROUND', 'citation': 'Hancock KE, Noel V, Ryugo DK, Delgutte B. Neural coding of interaural time differences with bilateral cochlear implants: effects of congenital deafness. J Neurosci. 2010 Oct 20;30(42):14068-79. doi: 10.1523/JNEUROSCI.3213-10.2010.'}, {'pmid': '10082295', 'type': 'BACKGROUND', 'citation': 'Hardie NA, Shepherd RK. Sensorineural hearing loss during development: morphological and physiological response of the cochlea and auditory brainstem. Hear Res. 1999 Feb;128(1-2):147-65. doi: 10.1016/s0378-5955(98)00209-3.'}, {'pmid': '10962187', 'type': 'BACKGROUND', 'citation': 'Leake PA, Snyder RL, Rebscher SJ, Moore CM, Vollmer M. Plasticity in central representations in the inferior colliculus induced by chronic single- vs. two-channel electrical stimulation by a cochlear implant after neonatal deafness. Hear Res. 2000 Sep;147(1-2):221-41. doi: 10.1016/s0378-5955(00)00133-7.'}, {'pmid': '22423717', 'type': 'BACKGROUND', 'citation': 'McKay CM. Forward masking as a method of measuring place specificity of neural excitation in cochlear implants: a review of methods and interpretation. J Acoust Soc Am. 2012 Mar;131(3):2209-24. doi: 10.1121/1.3683248.'}, {'pmid': '2744791', 'type': 'BACKGROUND', 'citation': 'Rattay F. Analysis of models for extracellular fiber stimulation. IEEE Trans Biomed Eng. 1989 Jul;36(7):676-82. doi: 10.1109/10.32099.'}, {'pmid': '17828665', 'type': 'BACKGROUND', 'citation': 'Sharma A, Gilley PM, Dorman MF, Baldwin R. Deprivation-induced cortical reorganization in children with cochlear implants. Int J Audiol. 2007 Sep;46(9):494-9. doi: 10.1080/14992020701524836.'}, {'pmid': '11273423', 'type': 'BACKGROUND', 'citation': 'Svirsky MA, Robbins AM, Kirk KI, Pisoni DB, Miyamoto RT. Language development in profoundly deaf children with cochlear implants. Psychol Sci. 2000 Mar;11(2):153-8. doi: 10.1111/1467-9280.00231.'}, {'pmid': '15454759', 'type': 'BACKGROUND', 'citation': 'Teoh SW, Pisoni DB, Miyamoto RT. Cochlear implantation in adults with prelingual deafness. Part II. Underlying constraints that affect audiological outcomes. Laryngoscope. 2004 Oct;114(10):1714-9. doi: 10.1097/00005537-200410000-00007.'}, {'pmid': '7130465', 'type': 'BACKGROUND', 'citation': 'Trune DR. Influence of neonatal cochlear removal on the development of mouse cochlear nucleus: I. Number, size, and density of its neurons. J Comp Neurol. 1982 Aug 20;209(4):409-24. doi: 10.1002/cne.902090410.'}, {'pmid': '6480511', 'type': 'BACKGROUND', 'citation': 'van den Honert C, Stypulkowski PH. Physiological properties of the electrically stimulated auditory nerve. II. Single fiber recordings. Hear Res. 1984 Jun;14(3):225-43. doi: 10.1016/0378-5955(84)90052-2.'}, {'pmid': '19275322', 'type': 'BACKGROUND', 'citation': 'Kong YY, Deeks JM, Axon PR, Carlyon RP. Limits of temporal pitch in cochlear implants. J Acoust Soc Am. 2009 Mar;125(3):1649-57. doi: 10.1121/1.3068457.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will study one of the basic biophysical properties of the auditory nerve, charge integration, behaviorally (detection threshold versus phase duration functions). The investigators will compare charge integration in two subject groups: congenitally deafened and deafened at a later age in life. The investigators will then examine if behaviorally estimated neural excitation patterns differ between short phase duration and long phase duration stimulation. Lastly, The investigators will measure if speech recognition improves with using long phase duration stimulation, relative to using the standard default short phase duration stimulation. The primary endpoint of the study is speech recognition, and the secondary endpoints are the steepness of the detection threshold versus phase duration functions, and the width of psychophysically estimated neural excitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adults with cochlear implants (Advanced Bionics and Cochlear Nucleus devices)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cochlear Nucleus cochlear implant users or Advanced Bionics cochlear implant users\n* Native speakers of English\n* Early onset of deafness (\\< 3 years of age); no requirement for age at implantation\n* Late onset of deafness (\\> 3 years of age); matched in duration of deafness to the early onset group\n* Has had device experience for at least one year\n* Can be child or adult at the time of enrollment\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03866850', 'briefTitle': 'Degenerative Consequences of Congenital Deafness', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Degenerative Consequences of Congenital Deafness', 'orgStudyIdInfo': {'id': 'Zhou_R01_study2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cochlear implant users with late-onset deafness', 'description': 'Examine charge integration (Detection threshold as a function of phase duration).\n\nExamine neural spatial excitation patterns with long and short phase duration. Measure speech recognition using long and short phase duration stimulation patterns.', 'interventionNames': ['Behavioral: Phase duration']}, {'label': 'Cochlear implant users with early-onset deafness', 'description': 'Examine charge integration (Detection threshold as a function of phase duration) and compare that with the late-onset group.\n\nExamine neural spatial excitation patterns with long and short phase duration within the non-leaky phase duration range.\n\nMeasure speech recognition using long and short phase duration stimulation patterns.', 'interventionNames': ['Behavioral: Phase duration']}], 'interventions': [{'name': 'Phase duration', 'type': 'BEHAVIORAL', 'description': 'We will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.', 'armGroupLabels': ['Cochlear implant users with early-onset deafness', 'Cochlear implant users with late-onset deafness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Department of Communication Sciences and Disorders, ECU', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Heather Wright', 'investigatorAffiliation': 'East Carolina University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-30', 'type': 'RELEASE'}, {'date': '2024-09-03', 'type': 'RESET'}, {'date': '2025-02-24', 'type': 'RELEASE'}, {'date': '2025-03-04', 'type': 'RESET'}, {'date': '2025-03-13', 'type': 'RELEASE'}, {'date': '2025-03-24', 'type': 'RESET'}, {'date': '2025-04-03', 'type': 'RELEASE'}, {'date': '2025-04-22', 'type': 'RESET'}, {'date': '2025-07-15', 'type': 'RELEASE'}, {'date': '2025-08-01', 'type': 'RESET'}, {'date': '2025-09-19', 'type': 'RELEASE'}, {'date': '2025-10-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Heather Wright, Professor, East Carolina University'}}}}