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Degenerative Consequences of Congenital Deafness

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ClinicalTrials.gov Identifier: NCT03866850
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
Ning Zhou, East Carolina University

Study Description
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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.

Condition or disease Intervention/treatment
Congenital Deafness Behavioral: Phase duration

Study Design
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Study Type : Observational
Estimated Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Degenerative Consequences of Congenital Deafness
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.

 Behavioral: 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.
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.

 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Children and adults with cochlear implants (Advanced Bionics and Cochlear Nucleus devices)
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:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866850


Contacts
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Contact: Ning Zhou, PhD 252-744-6147 zhoun@ecu.edu

Locations
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United States, North Carolina
Department of Communication Sciences and Disorders, ECU Recruiting
Greenville, North Carolina, United States, 27834
Contact: ning zhou       ningzhou1979@gmail.com   
Sponsors and Collaborators
East Carolina University
More Information
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Publications:

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Responsible Party: Ning Zhou, Associate Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT03866850    
Other Study ID Numbers: Zhou_R01_study2
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases