Novel Coding Strategies for Children With Cochlear Implants
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: Single-Electrode Pulse Train, Modulation Detection Threshold (MDT) and Gap Detection Tasks, Sound coding strategy., Electric-only spectral resolution.
- Who it may be relevant to
- Registry conditions: Deafness. Basic parameters: 6 years — 80 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 →
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Overview
The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory system. Information from individuals with and without cochlear implants will be compared.
Detailed description
The overall objectives of this research are to 1) gain a better understanding of fundamental psychophysical abilities with electrical stimulation as a function of age (child vs adult), age at onset of deafness (pre- vs post-lingual), and acoustic hearing (normal vs limited or residual); and 2) determine whether manipulations in CI coding strategies will improve psychophysical and speech recognition outcomes for early implanted children. This work is expected to provide new insights into the corresponding improvements in perceptual outcomes to these newer strategies have been modest at best and performance has begun to level off.
Interventions
- Other Single-Electrode Pulse Train
AIM 2 - Stimuli will be presented on one of three electrodes (apical, middle, and basal) at an amplitude between 10 and 100% dynamic range in µAs in 10% dynamic range steps. Stimulation will be delivered at a rate of 1000 pps. The process will be repeated in random order until 20 loudness estimates are obtained for each stimulus (3 electrodes x 2 rates x 10 amplitudes) for each subject. The dynamic range will be determined by measuring the maximum acceptable loudness (MAL) and threshold for each - Other Modulation Detection Threshold (MDT) and Gap Detection Tasks
AIM 1 - MDT will be set at 150 Hz. Testing will be conducted in soundfield in a sound booth at 60 dB Sound Pressure Level (SPL) while the participant listens with both implants adjusted to user setting. - Other Sound coding strategy.
Aim3 - Spectral-temporally modulated ripple test (SMRT), Quick Spectral Modulation Detection (QSMD), Modulation Detection, Gap Detection. CNC words will be set in quiet and Az-Bio/BabyBio sentences in quiet and multi-talker babble (+10 and +5 dB SNR) using both the subject's clinical map and the new reduced channels map. Tests will be presented in the soundfield at 60 dB SPL - Other Electric-only spectral resolution
Aim 1- Spectral resolution will be tested using frequency allocations consisting of the full default clinical range as well as the subject's clinical frequency allocation if they differ. For Hybrid electrode users in which electrode contacts are closer in proximity in the cochlea, maps with a frequency allocation of 938-7938 Hz will also be tested in that it will closely approximate the frequency spacing of a Nucleus Contour Advance electrode array. Spectral resolution will be measured with thre
Primary outcome measures
- Change in loudness growth in Cochlear Implant participants [Time frame: Baseline Visit (Day 1) , Visit week 10]
- Change in temporal resolution in Cochlear implant participants [Time frame: Baseline Visit (Day 1) , Visit week 10]
- Change in spectral resolution in Cochlear implant participants [Time frame: Baseline Visit (Day 1) , Visit week 10]
- Difference in performance between the reduced channel map and the full map [Time frame: Baseline Visit (Day 1) , Visit week 10]
Eligibility criteria
Inclusion criteria
- Be 7 years of age or older and pre-lingually implanted with a cochlear implant (before the age of 2 years), have aided residual hearing, or have normal hearing.
- Be ages 18 or older and post-lingually implanted or have normal hearing.
- Be ages 18-35 and pre-lingually implanted.
Exclusion criteria
- Any child implanted post-lingually
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT05203302 · 18-00437