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Clinical Trials/NCT05203302
NCT05203302
Recruiting
N/A

Novel Coding Strategies for Children With Cochlear Implants

NYU Langone Health1 site in 1 country190 target enrollmentJuly 12, 2018

Overview

Phase
N/A
Intervention
Single-Electrode Pulse Train
Conditions
Deafness
Sponsor
NYU Langone Health
Enrollment
190
Locations
1
Primary Endpoint
Change in spectral resolution in Cochlear implant participants
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory system. Information from individuals with and without cochlear implants will be compared.

Detailed Description

The overall objectives of this research are to 1) gain a better understanding of fundamental psychophysical abilities with electrical stimulation as a function of age (child vs adult), age at onset of deafness (pre- vs post-lingual), and acoustic hearing (normal vs limited or residual); and 2) determine whether manipulations in CI coding strategies will improve psychophysical and speech recognition outcomes for early implanted children. This work is expected to provide new insights into the corresponding improvements in perceptual outcomes to these newer strategies have been modest at best and performance has begun to level off.

Registry
clinicaltrials.gov
Start Date
July 12, 2018
End Date
January 1, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Be 7 years of age or older and pre-lingually implanted with a cochlear implant (before the age of 2 years), have aided residual hearing, or have normal hearing.
  • Be ages 18 or older and post-lingually implanted or have normal hearing.
  • Be ages 18-35 and pre-lingually implanted.

Exclusion Criteria

  • Any child implanted post-lingually

Arms & Interventions

Early Adult Cochlear Implant (EarlyAdultCI)

Early implanted adults, ages 18 to 35 years

Intervention: Single-Electrode Pulse Train

Early Adult Cochlear Implant (EarlyAdultCI)

Early implanted adults, ages 18 to 35 years

Intervention: Sound coding strategy.

Late Adult Cochlear Implant (LateAdultCI)

Post-lingually implanted adults, 18+ years

Intervention: Single-Electrode Pulse Train

Late Adult Cochlear Implant (LateAdultCI)

Post-lingually implanted adults, 18+ years

Intervention: Modulation Detection Threshold (MDT) and Gap Detection Tasks

Late Adult Cochlear Implant (LateAdultCI)

Post-lingually implanted adults, 18+ years

Intervention: Sound coding strategy.

Early Child Cochlear Implant (EarlyChildCI)

Early implanted children, ages 7-17 years

Intervention: Modulation Detection Threshold (MDT) and Gap Detection Tasks

Early Child Cochlear Implant (EarlyChildCI)

Early implanted children, ages 7-17 years

Intervention: Sound coding strategy.

Early Child Cochlear Implant (EarlyChildCI)

Early implanted children, ages 7-17 years

Intervention: Electric-only spectral resolution

Cochlear Implant (CI)

CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral)

Intervention: Electric-only spectral resolution

Normal Hearing Children (NHC)

Ages 7-17 years, Control Group

Intervention: Modulation Detection Threshold (MDT) and Gap Detection Tasks

Normal Hearing Adults (NHA)

18+ years, Control Group

Intervention: Modulation Detection Threshold (MDT) and Gap Detection Tasks

Outcomes

Primary Outcomes

Change in spectral resolution in Cochlear implant participants

Time Frame: Baseline Visit (Day 1) , Visit week 10

A one-way ANOVA will be used to calculate the differences between the four groups. If significant, post-hoc t-tests will be performed using Rom's modified Bonferroni Type I error correction.

Difference in performance between the reduced channel map and the full map

Time Frame: Baseline Visit (Day 1) , Visit week 10

A mixed-design ANOVA will be conducted for each of the tests with subject population as the between-subjects factor and sound coding strategy as the within-subjects factor

Change in temporal resolution in Cochlear implant participants

Time Frame: Baseline Visit (Day 1) , Visit week 10

A mixed-effect ANOVA will be conducted to determine if there is an effect of age group (children vs adults) and hearing condition (CI vs NH) for both modulation detection and gap detection tasks. Post-hoc two-sample t-tests will compare differences between NH and CI children as well as NH and CI adults. Post-hoc paired t-tests will compare differences between adults and children for both the NH and the CI populations.

Change in loudness growth in Cochlear Implant participants

Time Frame: Baseline Visit (Day 1) , Visit week 10

Power functions will be fit for each of the loudness growth curves. Data will be analyzed using a mixed-design ANOVA with the two groups as the between-subjects factor and electrode and rate as within-subject factors.

Study Sites (1)

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