- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03866850
Degenerative Consequences of Congenital Deafness
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Greenville, North Carolina, United States, 27834
- Department of Communication Sciences and Disorders, ECU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cochlear Nucleus cochlear implant users or Advanced Bionics cochlear implant users
- Native speakers of English
- Early onset of deafness (< 3 years of age); no requirement for age at implantation
- Late onset of deafness (> 3 years of age); matched in duration of deafness to the early onset group
- Has had device experience for at least one year
- Can be child or adult at the time of enrollment
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cochlear implant users with late-onset deafness
Examine charge integration (Detection threshold as a function of phase duration). Examine neural spatial excitation patterns with long and short phase duration. Measure speech recognition using long and short phase duration stimulation patterns. |
We will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.
|
Cochlear implant users with early-onset deafness
Examine charge integration (Detection threshold as a function of phase duration) and compare that with the late-onset group. Examine neural spatial excitation patterns with long and short phase duration within the non-leaky phase duration range. Measure speech recognition using long and short phase duration stimulation patterns. |
We will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Slope of the strength duration function
Time Frame: starting 6 months post award notice and will take up to 4 years to complete
|
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.
|
starting 6 months post award notice and will take up to 4 years to complete
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychophysically estimated neural excitation width
Time Frame: starting 6 months post award notice and will take up to 4 years to complete
|
Subjects will be measured for psychophysical forward-masked spatial tuning curves using stimuli with long and short phase duration.
|
starting 6 months post award notice and will take up to 4 years to complete
|
Speech recognition using long phase duration
Time Frame: starting 6 months post award notice and will take up to 4 years to complete
|
Subjects' speech recognition performance will be evaluated using CUNY and TIMIT sentences with long and short phase duration stimulation.
|
starting 6 months post award notice and will take up to 4 years to complete
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Rattay F. Analysis of models for extracellular fiber stimulation. IEEE Trans Biomed Eng. 1989 Jul;36(7):676-82. doi: 10.1109/10.32099.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Zhou_R01_study2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Deafness
-
Clinica Universidad de Navarra, Universidad de...University Hospital, Montpellier; University Hospital, Toulouse; Asociacion Instituto... and other collaboratorsUnknownCongenital Deafness | Suspicion of Congenital DeafnessFrance
-
RWTH Aachen UniversityAdvanced BionicsCompletedDeafness, Bilateral | Deafness Unilateral | Deafness Congenital | Deafness, AcquiredGermany
-
University of North Carolina, Chapel HillMed-El CorporationRecruitingHearing Loss | Congenital Hearing Loss | Hearing Loss, Unilateral | Single Sided Deafness | Unilateral Deafness | Deafness One EarUnited States
-
Dan BingNot yet recruitingCongenital Hearing Loss | Congenital Deafness
-
University of Colorado, DenverNational Institute on Deafness and Other Communication Disorders (NIDCD); University...CompletedCongenital Sensorineural DeafnessUnited States
-
University Hospital, Strasbourg, FranceInstitut National de la Santé Et de la Recherche Médicale, France; Centre National... and other collaboratorsCompleted
-
SensorionNot yet recruitingOtorhinolaryngologic Diseases | Ear Diseases | Hearing Disorders | Deafness | Hearing Loss, Sensorineural | Congenital Deafness | DFNB9 | OTOF Gene MutationFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingCochlear Implantation | Profound Congenital DeafnessFrance
-
National Eye Institute (NEI)CompletedRetinitis Pigmentosa | Usher Syndrome | Retinitis Pigmentosa Syndromic | Congenital Deafness | Retinitis Pigmentosa and DeafnessUnited States
-
Oticon MedicalCompletedUnilateral Deafness | Bone Conduction Deafness | Mixed Hearing Loss | Middle Ear DeafnessNetherlands
Clinical Trials on Phase duration
-
Sanliurfa Mehmet Akif Inan Education and Research...CompletedPost Term PregnancyTurkey
-
Organon and CoCompleted
-
ThuasneRecruiting
-
Children's Hospital Medical Center, CincinnatiUganda Heart InstituteCompletedRheumatic Heart DiseaseUganda
-
University of EdinburghNHS Lothian; NHS Greater Glasgow and ClydeUnknownMyocardial Infarction | Acute Coronary Syndrome
-
Duke UniversityNational Institute of Mental Health (NIMH)Completed
-
Bharat Biotech International LimitedIndian Council of Medical ResearchCompletedCOVID-19 | SARS-CoV-2 InfectionIndia
-
Kocaeli UniversityRecruitingPain | Satisfaction | Fear of Childbirth | Neonatal | Maternal Distress (During Labor)Turkey
-
Janssen Research & Development, LLCCompletedRelapsed or Refractory Hodgkin LymphomaFrance, Germany
-
University of AvignonCompleted