Degenerative Consequences of Congenital Deafness

Terminated

• Conditions: Congenital Deafness
• Interventions: Behavioral: Phase duration

• Registration Number: NCT03866850
• Lead Sponsor: East Carolina University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Study Start: 2019-08-01
• Status Verified: 2023-04
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cochlear implant users with late-onset deafness	Phase duration	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.
Cochlear implant users with early-onset deafness	Phase duration	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.

Primary Outcome Measures

Name	Time	Method
Slope of the strength duration function	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

Name	Time	Method
Psychophysically estimated neural excitation width	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.
Speech recognition using long phase duration	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.

Trial Locations

Locations (1)

Department of Communication Sciences and Disorders, ECU; 🇺🇸 Greenville, North Carolina, United States