Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2018
CompletedFirst Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 30, 2025
December 1, 2025
8 years
March 20, 2023
December 23, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Day 1 (Visit 1 - Average visit length is about 3 hours)
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.
Day 1 (Visit 1 - Average visit length is about 3 hours)
Study Arms (1)
Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices
EXPERIMENTALTwo 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
Measurements taken from the electrode-neural interface will be used to guide elimination of poorly functioning ABI electrodes and improve speech perception outcomes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Diagnosed cognitive or communicative disorders (other than hearing impairment)
- Severe neurological disorders
- No useable electrodes in their implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Cochlear Americascollaborator
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahan Azadpour
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2023
First Posted
April 12, 2023
Study Start
December 2, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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
- 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.
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.