A Computational Approach to Optimal Deactivation of Cochlear Implant Electrodes

NCT ID: NCT05219474

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-04-30

Brief Summary

The goal of the present study is to use computationally driven models of speech understanding in cochlear implant (CI) users to guide the search for which combination of active electrodes can yield the best speech understanding for a specific patient. It is hypothesized that model-recommended settings will result in significantly better speech understanding than standard-of-care settings.

Detailed Description

Aim 1 is to quantify speech understanding and sound quality with model-recommended combinations of active electrodes compared to standard settings, and compared to two control active electrode combinations. Aim 2 is to translate the model-driven recommendations from Aim 1 into practical guidance about how many (and possibly which) CI electrodes to deactivate.

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cochlear implant subjects

Participates in 7 visits over a six-month duration. Subjects will be given several tests that require them to listen to sounds presented to their cochlear implant and answer questions about those sounds.

Group Type: EXPERIMENTAL

Cochlear implant Computer Model Implementation

Intervention Type: DIAGNOSTIC_TEST

The computer model will use standard Cochlear Implant settings to evaluate psychophysical and speech understanding abilities and sound quality with standard CI settings and then use these measures to build subject-specific models and determine experimental active electrode conditions to be tested: model-optimized, and two best-electrodes settings (2 types); 3) evaluate speech understanding and sound quality measures after using experimental settings regularly for 1.5 months; and 4) compare performance across experimental and clinical conditions.

The analysis will include four levels of repeated measures with active CI electrode conditions. These levels include the clinical baseline condition (all available electrodes active) and three experimental conditions (model-optimized, best-electrodes, and restricted best-electrodes).

Normal hearing subjects

Participates in 1 visit lasting 3 hours. Will be given several tests that require you to listen to sounds and answer questions about those sounds. The sounds will be distorted in ways that approximate how a cochlear implant sounds.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cochlear implant Computer Model Implementation

The computer model will use standard Cochlear Implant settings to evaluate psychophysical and speech understanding abilities and sound quality with standard CI settings and then use these measures to build subject-specific models and determine experimental active electrode conditions to be tested: model-optimized, and two best-electrodes settings (2 types); 3) evaluate speech understanding and sound quality measures after using experimental settings regularly for 1.5 months; and 4) compare performance across experimental and clinical conditions.

The analysis will include four levels of repeated measures with active CI electrode conditions. These levels include the clinical baseline condition (all available electrodes active) and three experimental conditions (model-optimized, best-electrodes, and restricted best-electrodes).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Cochlear implant subjects

• must be older than the age of 18
• implanted unilaterally with CI with at least 1 year of experience
• no diagnosis of any other communicative or cognitive disorder.
• English-speaking
• willingness and ability to provide informed consent

Normal hearing subjects

• must be older than age of 18
• no diagnosis of any other communicative or cognitive disorder.
• English-speaking
• willingness and ability to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elad Sagi, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R21DC020293-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-01661

Identifier Type: -

Identifier Source: org_study_id