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Clinical Trials/NCT03866850
NCT03866850
Terminated
N/A

Degenerative Consequences of Congenital Deafness

East Carolina University1 site in 1 country34 target enrollmentAugust 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congenital Deafness
Sponsor
East Carolina University
Enrollment
34
Locations
1
Primary Endpoint
Slope of the strength duration function
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
April 4, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heather Wright

Professor

East Carolina University

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Psychophysically estimated neural excitation width(starting 6 months post award notice and will take up to 4 years to complete)
  • Speech recognition using long phase duration(starting 6 months post award notice and will take up to 4 years to complete)

Study Sites (1)

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