Recruiting

Auditory Processing

Sponsor:

NYU Langone Health

Code:

NCT05810220

Conditions

Deafness

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Interventions

Electrode-Neural Interface

Study Details

Brief summary:

This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices. The study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.

Conditions

Deafness

Study ID

NCT05810220

Start date

Dec 2, 2018

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Hearing impaired adult and or child (above 2 years old) who uses ABIs or cochlear implants.
  • No diagnosis of any other communicative or cognitive disorder other than hearing impairment. The individual must be able to visit the lab in order to participate in behavioral and electrophysiological experiments.
  • Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation.

Exclusion Criteria:

  • Diagnosed cognitive or communicative disorders (other than hearing impairment)
  • Severe neurological disorders
  • No useable electrodes in their implants

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices

Two types of measurements will be obtained:

1. Perceptual: one or more sounds are presented and a behavioral response is collected (e.g., judgements of loudness, pitch or other differences between the sounds, or identifying the word or sentence that was said).
2. Physiological: noninvasive electrophysiological recordings of nervous system activity.

Interventions

Electrode-Neural Interface

Measurements taken from the electrode-neural interface will be used to guide elimination of poorly functioning ABI electrodes and improve speech perception outcomes.

Primary outcome measure

  • Percent of Correctly-Identified Speech Materials [ Time Frame: Day 1 (Visit 1 - Average visit length is about 3 hours) ]
  • Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented [ Time Frame: Day 1 (Visit 1 - Average visit length is about 3 hours) ]

Central Contacts and Locations

Central contacts

Mahan Azadpour

2122637785Mahan.Azadpour@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-30.