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

Primary Purpose

Deafness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrode-Neural Interface
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Deafness

Eligibility Criteria

2 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent of Correctly-Identified Speech Materials
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.
Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented
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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
April 13, 2023
Sponsor
NYU Langone Health
Collaborators
Cochlear Americas
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1. Study Identification

Unique Protocol Identification Number
NCT05810220
Brief Title
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Official Title
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Cochlear Americas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electrode-Neural Interface
Intervention Description
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 Information:
Title
Percent of Correctly-Identified Speech Materials
Description
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.
Time Frame
Day 1 (Visit 1 - Average visit length is about 3 hours)
Title
Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented
Description
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.
Time Frame
Day 1 (Visit 1 - Average visit length is about 3 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahan Azadpour
Phone
2122637785
Email
Mahan.Azadpour@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahan Azadpour
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Mahan.Azadpour@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Mahan.Azadpour@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

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

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