Novel Coding Strategies for Children With Cochlear Implants

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

Sponsor
NYU Langone Health
Study ID
NCT05203302
Status
Recruiting
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Conditions

  • Deafness

Eligibility Criteria

Sex
ALL
Age
6 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Single-Electrode Pulse Train — OTHER
    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 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
    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.
  • Sound coding strategy. — OTHER
    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
  • Electric-only spectral resolution — OTHER
    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 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.

Study Details

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.

Key Dates

Start date
Jul 12, 2018
Status verified
Mar 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
190 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Late Adult Cochlear Implant (LateAdultCI)
    Post-lingually implanted adults, 18+ years
  • Experimental: Early Child Cochlear Implant (EarlyChildCI)
    Early implanted children, ages 7-17 years
  • Experimental: Early Adult Cochlear Implant (EarlyAdultCI)
    Early implanted adults, ages 18 to 35 years
  • Experimental: Cochlear Implant (CI)
    CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral)
  • Active Comparator: Normal Hearing Children (NHC)
    Ages 7-17 years, Control Group
  • Active Comparator: Normal Hearing Adults (NHA)
    18+ years, Control Group

Primary Outcome Measure

Change in loudness growth in Cochlear Implant participants [ Time Frame: Baseline Visit (Day 1) , Visit week 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
David M Landsberger, MD
[email protected]
212-263-8455
David M Landsberger, MD (PRINCIPAL_INVESTIGATOR)

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By research site
NYU Langone Health· New York, NY

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