Clinical trial NCT05219474: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-02-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Vowel and consonant identification
timeFrame: 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)
measure: Change in Word recognition
timeFrame: 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)
measure: Change in Sentence recognition
timeFrame: 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)
measure: Change in Electrode discrimination
timeFrame: 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)
measure: Change in Pitch Scaling
timeFrame: 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)
measure: Change in Sound Quality
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Elad Sagi, MD
role: PRINCIPAL_INVESTIGATOR
References: