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

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05810220
Collaborator
Cochlear Americas (Other)
200
1
1
64.9
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Electrode-Neural Interface
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Actual Study Start Date :
Dec 2, 2018
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices

Two types of measurements will be obtained: 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). Physiological: noninvasive electrophysiological recordings of nervous system activity.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Percent of Correctly-Identified Speech Materials [Day 1 (Visit 1 - Average visit length is about 3 hours)]

    Participants will listen to speech sounds and indicate what sentence or word they heard. The outcome is the percent of speech sounds that are correctly identified.

  2. Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented [Day 1 (Visit 1 - Average visit length is about 3 hours)]

    Two or more stimuli will be presented to participants, who will indicate which one is louder, which is higher pitched, or which one is different. The outcome is the percent of stimuli characteristics that are correctly identified.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • Cochlear Americas

Investigators

  • Principal Investigator: Mahan Azadpour, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05810220
Other Study ID Numbers:
  • 18-00323
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023