Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
ConditionDeafness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-90
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Diagnosed cognitive or communicative disorders (other than hearing impairment)
Severe neurological disorders
No useable electrodes in their implants
Trial design
Design model
Single group
Treatments tested in this trial
Electrode-Neural Interface
DeviceMeasurements taken from the electrode-neural interface will be used to guide elimination of poorly functioning ABI electrodes and improve speech perception outcomes.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) DevicesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1 (Visit 1 - Average visit length is about 3 hours)2
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.
Time frame
Day 1 (Visit 1 - Average visit length is about 3 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
Cochlear Americas
Collaborator
Source ClinicalTrials.gov