Degenerative Consequences of Congenital Deafness

NCT ID: NCT03866850

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2023-04-04

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Deafness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Phase duration

Intervention Type BEHAVIORAL

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.

Phase duration

Intervention Type BEHAVIORAL

We will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.

Interventions

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Phase duration

We will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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East Carolina University

OTHER

Sponsor Role lead

Responsible Party

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Heather Wright

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Communication Sciences and Disorders, ECU

Greenville, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23462803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20962228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10082295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10962187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22423717 (View on PubMed)

Rattay F. Analysis of models for extracellular fiber stimulation. IEEE Trans Biomed Eng. 1989 Jul;36(7):676-82. doi: 10.1109/10.32099.

Reference Type BACKGROUND
PMID: 2744791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17828665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11273423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15454759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7130465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6480511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19275322 (View on PubMed)

Other Identifiers

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Zhou_R01_study2

Identifier Type: -

Identifier Source: org_study_id

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