Novel Coding Strategies for Children With Cochlear Implants
ConditionDeafness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-80
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Any child implanted post-lingually
Trial design
Design model
Parallel
Treatments tested in this trial
Single-Electrode Pulse Train
Other interventionAIM 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 of the stimuli. MAL will be measured by slowly raising the current level for each stimulus until the subject reports that it is as loud as they are willing to accept without becoming uncomfortably loud.
Modulation Detection Threshold (MDT) and Gap Detection Tasks
Other interventionAIM 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.
Sound coding strategy.
Other interventionAim3 - 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
Electric-only spectral resolution
Other interventionAim 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 three repetitions of the SMRT and one repetition of the QSMD test. Testing will be presented at 60 dB SPL in the soundfield with the acoustic ear plugged and muffed.
Treatment groups
190 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Late Adult Cochlear Implant (LateAdultCI)Experimental treatment 3 interventions
Group B: Early Child Cochlear Implant (EarlyChildCI)Experimental treatment 3 interventions
Group C: Early Adult Cochlear Implant (EarlyAdultCI)Experimental treatment 2 interventions
Group D: Cochlear Implant (CI)Experimental treatment 1 intervention
Group E: Normal Hearing Children (NHC)Active comparator 1 intervention
Group F: Normal Hearing Adults (NHA)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in loudness growth in Cochlear Implant participants
Power functions will be fit for each of the loudness growth curves. Data will be analyzed using a mixed-design ANOVA with the two groups as the between-subjects factor and electrode and rate as within-subject factors.
Time frame
Baseline Visit (Day 1) , Visit week 102
Change in temporal resolution in Cochlear implant participants
A mixed-effect ANOVA will be conducted to determine if there is an effect of age group (children vs adults) and hearing condition (CI vs NH) for both modulation detection and gap detection tasks. Post-hoc two-sample t-tests will compare differences between NH and CI children as well as NH and CI adults. Post-hoc paired t-tests will compare differences between adults and children for both the NH and the CI populations.
Time frame
Baseline Visit (Day 1) , Visit week 103
Change in spectral resolution in Cochlear implant participants
A one-way ANOVA will be used to calculate the differences between the four groups. If significant, post-hoc t-tests will be performed using Rom's modified Bonferroni Type I error correction.
Time frame
Baseline Visit (Day 1) , Visit week 104
Difference in performance between the reduced channel map and the full map
A mixed-design ANOVA will be conducted for each of the tests with subject population as the between-subjects factor and sound coding strategy as the within-subjects factor
Time frame
Baseline Visit (Day 1) , Visit week 10Sponsors and contacts
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Source ClinicalTrials.gov