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Novel Coding Strategies for Children With Cochlear Implants

NYU Langone Health logo

NYU Langone Health

Status

Enrolling

Conditions

Deafness

Treatments

Other: Sound coding strategy.
Other: Electric-only spectral resolution
Other: Single-Electrode Pulse Train
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks

Study type

Interventional

Funder types

Other

Identifiers

NCT05203302
18-00437

Details and patient eligibility

About

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.

Full 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.

Enrollment

190 estimated patients

Sex

All

Ages

6 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

190 participants in 6 patient groups

Late Adult Cochlear Implant (LateAdultCI)
Experimental group
Description:
Post-lingually implanted adults, 18+ years
Treatment:
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks
Other: Single-Electrode Pulse Train
Other: Sound coding strategy.
Early Child Cochlear Implant (EarlyChildCI)
Experimental group
Description:
Early implanted children, ages 7-17 years
Treatment:
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks
Other: Electric-only spectral resolution
Other: Sound coding strategy.
Early Adult Cochlear Implant (EarlyAdultCI)
Experimental group
Description:
Early implanted adults, ages 18 to 35 years
Treatment:
Other: Single-Electrode Pulse Train
Other: Sound coding strategy.
Cochlear Implant (CI)
Experimental group
Description:
CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral)
Treatment:
Other: Electric-only spectral resolution
Normal Hearing Children (NHC)
Active Comparator group
Description:
Ages 7-17 years, Control Group
Treatment:
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks
Normal Hearing Adults (NHA)
Active Comparator group
Description:
18+ years, Control Group
Treatment:
Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks

Trial contacts and locations

1

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Central trial contact

David M Landsberger, MD; Natalia Stupak

Data sourced from clinicaltrials.gov

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