A Computational Approach to Optimal Deactivation of Cochlear Implant Electrodes

The goal of the present study is to use computationally driven models of speech understanding in 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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Diagnostic test: Cochlear implant Computer Model Implementation

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elad Sagi; Phone Number: 212-263-7765; Email: Elad.Sagi@nyulangone.org
• Study Contact Backup: Name: Mario Svirsky; Phone Number: 212-263-7217; Email: mario.svirsky@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Mario Svirsky; Phone Number: 212-263-7217; Email: mario.svirsky@nyulangone.org
      • Principal Investigator: Elad Sagi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

not meeting the inclusion criteria above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vowel and consonant identification	Vowel and consonant identification testing will include 9 vowels in /hVd/ context and 16 consonants in /aCa/ context presented in quiet. Each phoneme will be presented 15 times. Vowel and consonant testing will be done during initial speech testing using clinical CI settings. Subject confusion matrices (i.e. number of correct responses and specific confusions) will serve as the basis for model construction.	Baseline Visit (Day 0), Visit 1 (Day 1), Visit 2 (Day 2), Visit 3 (6 weeks), Visit 4 (12 weeks), Visit 5 (18 weeks), Visit 6 (24 weeks)
Change in Word recognition	Word recognition testing will consist of a CNC monosyllabic word test that includes 30 lists of 50 words each presented in quiet. Participants will complete three CNC word lists per testing session, and word lists will be blocked across testing sessions so no word list is repeated. Word recognition scores will be used to evaluate performance with clinical and experimental CI settings. Word scores with clinical settings will also be used for model development.	Baseline Visit (Day 0), Visit 1 (Day 1), Visit 2 (Day 2), Visit 3 (6 weeks), Visit 4 (12 weeks), Visit 5 (18 weeks), Visit 6 (24 weeks)
Change in Sentence recognition	Sentence recognition testing will consist of AzBio sentences tested in +10 dB SNR multi-talker babble. The test includes 33 lists of 20 sentences with approximately 150 words per list. Participants will complete two lists per testing session, and lists will be blocked across testing sessions so no lists are repeated. Sentence recognition scores in noise will help evaluate generalization of performance with experimental settings to other speech tasks and in other listening conditions. Speech stimuli will be presented at 65 dB SPL (C-weighted) in a sound attenuated room as measured from CI user's microphone.	Baseline Visit (Day 0), Visit 1 (Day 1), Visit 2 (Day 2), Visit 3 (6 weeks), Visit 4 (12 weeks), Visit 5 (18 weeks), Visit 6 (24 weeks)
Change in Electrode discrimination	Electrode discrimination will be measured as a JND relative to every active CI electrode in both basal and apical directions. Individual electrodes will be stimulated with 500ms pulse trains at comfortable loudness-balanced levels. JND for each reference electrode will be measured adaptively using a 4-interval 2AFC 2-down/1-up procedure. Electrode discrimination JNDs will serve as inputs to build the proposed subject-specific models.	Baseline Visit (Day 0), Visit 1 (Day 1), Visit 2 (Day 2), Visit 3 (6 weeks), Visit 4 (12 weeks), Visit 5 (18 weeks), Visit 6 (24 weeks)
Change in Pitch Scaling	Subjects will be instructed to assign a number from 1 to 100 that corresponds to their perceived pitch of a stimulated electrode (100 highest in pitch). Each electrode will be stimulated once per block using 500ms pulse trains at comfortable loudness-balanced levels, presented in random order. A trimmed mean of pitch ratings (discarding lowest and highest ratings) for the last eight of ten blocks will be used to determine the final score. Pitch scaling will be used to evaluate whether electrodes are perceived as well ordered in pitch, and will be measured with clinical CI settings.	Baseline Visit (Day 0), Visit 1 (Day 1), Visit 2 (Day 2), Visit 3 (6 weeks), Visit 4 (12 weeks), Visit 5 (18 weeks), Visit 6 (24 weeks)
Change in Sound Quality	A shortened version of the speech, spatial, and qualities of hearing scale, or SSQ will be administered when using clinical CI settings, and after using experimental CI settings for 1.5 months. The SSQ is a self-assessment questionnaire measuring hearing disability across three domains. The shortened version, SSQ12, includes 12 questions across the three domains. Each question is answered using a 10-point scale ranging for poorest (i.e. 0) to best (i.e 10) performance. The average score across questions will be used to evaluate sound quality across CI settings conditions and across subjects. The SSQ12 has previously been validated in CI users, and is highly correlated with results from the original 49 item SSQ.	Baseline Visit (Day 0), Visit 1 (Day 1), Visit 2 (Day 2), Visit 3 (6 weeks), Visit 4 (12 weeks), Visit 5 (18 weeks), Visit 6 (24 weeks)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Elad Sagi, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 21-01661; R21DC020293-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No