Recruiting

Cochlear Implants

Sponsor:

NYU Langone Health

Code:

NCT05203302

Conditions

Deafness

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

Interventions

Single-Electrode Pulse Train

Modulation Detection Threshold (MDT) and Gap Detection Tasks

Sound coding strategy.

Electric-only spectral resolution

Study Details

Brief summary:

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.

Conditions

Deafness

Study ID

NCT05203302

Start date

Jul 12, 2018

Status verified date

Mar, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

190 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

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 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

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.

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

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

David M Landsberger, MD

212-263-8455david.landsberger@nyulangone.org

Natalia Stupak

646-501-4153natalia.stupak@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

David M Landsberger, MD

212-263-8455david.landsberger@nyulangone.org

Principal Investigator:

David M Landsberger, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-04.