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Neural Interface
Auditory Implant Evaluation for Hearing Loss
N/A
Recruiting
Led By Mahan Azadpour
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must not have
Severe neurological disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (visit 1 - average visit length is about 3 hours)
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the hearing of adults and kids with hearing impairments who use implants to hear. It will evaluate how well the implants work.
Who is the study for?
This trial is for hearing-impaired adults and children over 2 years old who use cochlear or auditory brainstem implants. Participants must not have other cognitive or communicative disorders, severe neurological issues, and their implant's electrodes must be functional without causing discomfort.
What is being tested?
The study investigates how well people with cochlear or auditory brainstem implants process sounds. It involves behavioral and electrophysiological experiments conducted in a lab setting to evaluate the effectiveness of these devices in restoring hearing functions.
What are the potential side effects?
Since this is an observational study focusing on auditory processing, there are no direct side effects from interventions like drugs or surgeries. However, participants may experience fatigue or discomfort during testing procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am hearing impaired and use an ABI or cochlear implant.
Select...
I have no cognitive disorders except for hearing impairment and can visit the lab.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe neurological disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (visit 1 - average visit length is about 3 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (visit 1 - average visit length is about 3 hours)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of Correctly-Identified Speech Materials
Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) DevicesExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Cochlear AmericasUNKNOWN
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,385 Total Patients Enrolled
10 Trials studying Deafness
1,674 Patients Enrolled for Deafness
Mahan AzadpourPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have functioning electrodes in your implants.I have a severe neurological disorder.I am hearing impaired and use an ABI or cochlear implant.I have no cognitive disorders except for hearing impairment and can visit the lab.You have trouble thinking clearly or communicating with others, except for hearing problems.
Research Study Groups:
This trial has the following groups:- Group 1: Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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