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A Computational Approach to Optimal Deactivation of Cochlear Implant Electrodes

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cochlear implant Computer Model Implementation
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cochlear implant subjects

Normal hearing subjects

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
July 6, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05219474
Brief Title
A Computational Approach to Optimal Deactivation of Cochlear Implant Electrodes
Official Title
A Computational Approach to Optimal Deactivation of Cochlear Implant Electrodes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cochlear implant subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal hearing subjects
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cochlear implant Computer Model Implementation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Vowel and consonant identification
Description
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.
Time Frame
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)
Title
Change in Word recognition
Description
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.
Time Frame
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)
Title
Change in Sentence recognition
Description
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.
Time Frame
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)
Title
Change in Electrode discrimination
Description
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.
Time Frame
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)
Title
Change in Pitch Scaling
Description
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.
Time Frame
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)
Title
Change in Sound Quality
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Exclusion Criteria: not meeting the inclusion criteria above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elad Sagi
Phone
212-263-7765
Email
Elad.Sagi@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Svirsky
Phone
212-263-7217
Email
Mario.Svirsky@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elad Sagi, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Svirsky
Phone
212-263-7217
Email
mario.svirsky@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Elad Sagi, MD

12. IPD Sharing Statement

Learn more about this trial

A Computational Approach to Optimal Deactivation of Cochlear Implant Electrodes

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