Novel Coding Strategies for Children With Cochlear Implants

Not Applicable

Recruiting

• Conditions: Deafness

• Registration Number: NCT05203302
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2018-07-12
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in spectral resolution in Cochlear implant participants	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	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	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	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States