Menu
Recruiting NCT05810220

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

No phase Interventional Deafness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrode-Neural Interface.
Who it may be relevant to
Registry conditions: Deafness. Basic parameters: 2 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Percent of Correctly-Identified Speech Materials [Time frame: Day 1 (Visit 1 - Average visit length is about 3 hours)]
  • Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented [Time frame: Day 1 (Visit 1 - Average visit length is about 3 hours)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05810220 · 18-00323

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗