Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07039435
Status
Recruiting

Conditions

  • Cochlear Implantation
  • Perceptual Adaptation
  • Sensorineural Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alternative Frequency Mapping — OTHER
    Patients will have their speech processors programmed with four maps, three of which use a higher low-frequency cutoff than the default map (313 Hz, 438 Hz, 563 Hz, compared to the default map that has a low-frequency cutoff of 188 Hz).

Study Details

The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception.

Key Dates

Start date
Apr 3, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users
    Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care (i.e., 188-7938 Hz for Cochlear users) and the other three will have higher low frequency edges than the standard of care default maps (starting at 313, 438, and 563 Hz, respectively). These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week.

Primary Outcome Measure

Bilateral speech perception as measured by Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score while using standard 188 Hz Frequency-Allocation Table (FAT) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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