Early Cochlear Implant Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Take home tests.
- Who it may be relevant to
- Registry conditions: Cochlear Implant Users. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Take-home computers and test-equipment will be sent home, and subjects will complete approximately 25 test sessions over the first 3 months of cochlea implant use. Then, subjects will be tested 3 more times in the laboratory until 1 year-post activation. The primary objective is to determine and quantify how sounds change and speech perception improves over the course of early cochlear implant use.
Interventions
- Other Take home tests
These tests will test the discriminability of sounds that vary systematically along the frequency and temporal dimensions of sound. Over the course of the 3 months post-activation, subjects will self-complete "take-home" tests at location of their choosing. Each test session will include the entire test-battery will be repeated frequency as often as every day and then reducing frequency of testing corresponding to the rate of speech perception improvement.
Primary outcome measures
- Change in percentage of correct responses during speech perception tests [Time frame: Baseline, 1 year]
Eligibility criteria
Inclusion criteria
- Postlingually deaf cochlear implant users
- severe or profound hearing loss
- who do not have other diagnoses communicative or cognitive disorders.
- Test population: no prior experience with cochlear implants (recruitment happens prior to cochlear implantation).
- Control population: subjects who have used the same stimulation strategy since initial stimulation, who note no continuing improvements or changes with their devices with respect to speech comprehension.
Exclusion criteria
- Diagnosed cognitive or communicative disorders (other than deafness)
- Below 18 years of age
- Above the age of 85 years old.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07114744 · 24-01603 · K99DC021727