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

Deafness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810220
• Other study ID #: 18-00323
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2018
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Mahan Azadpour
• Phone: 2122637785
• Email: Mahan.Azadpour[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Cochlear Americas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)