Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants

NCT ID: NCT05810220

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-02

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Deafness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Electrode-Neural Interface

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear Americas

UNKNOWN

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahan Azadpour

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mahan Azadpour

Role: CONTACT

Phone: 2122637785

Email: [email protected]

Other Identifiers

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18-00323

Identifier Type: -

Identifier Source: org_study_id