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Clinical Trials/NCT05810220
NCT05810220RecruitingNot Applicable

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

NYU Langone Health1 site in 1 country200 target enrollmentStarted: December 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
2 Years to 90 Years (Child, Adult, Older Adult)
Sex
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

Arms & Interventions

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

Experimental

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.

Intervention: Electrode-Neural Interface (Device)

Outcomes

Primary Outcomes

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)

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.

Percent of Correctly-Identified Speech Materials

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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