DeafnessNCT05203302
Novel Coding Strategies for Children With Cochlear Implants
A study testing Single-Electrode Pulse Train, Modulation Detection Threshold (MDT) and Gap Detection Tasks and Sound coding strategy. in people with Deafness, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Single-Electrode Pulse Train, Modulation Detection Threshold (MDT) and Gap Detection Tasks and Sound coding strategy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any child implanted post-lingually
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
David M Landsberger, MD, 212-263-8455, david.landsberger@nyulangone.org
David M Landsberger, MD
About this study
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.
Read the 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.
- Conditions
- Deafness
- Being tested
- Single-Electrode Pulse Train, Modulation Detection Threshold (MDT) and Gap Detection Tasks, Sound coding strategy., Electric-only spectral resolution
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Electrode Pulse TrainOther
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 TasksOther
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 resolutionOther
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 group | Role | What they receive |
|---|---|---|
| Late Adult Cochlear Implant (LateAdultCI) | Experimental | Post-lingually implanted adults, 18+ years Receives: Other: Single-Electrode Pulse Train; Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks; Other: Sound coding strategy. |
| Early Child Cochlear Implant (EarlyChildCI) | Experimental | Early implanted children, ages 7-17 years Receives: Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks; Other: Sound coding strategy.; Other: Electric-only spectral resolution |
| Early Adult Cochlear Implant (EarlyAdultCI) | Experimental | Early implanted adults, ages 18 to 35 years Receives: Other: Single-Electrode Pulse Train; Other: Sound coding strategy. |
| Cochlear Implant (CI) | Experimental | CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral) Receives: Other: Electric-only spectral resolution |
| Normal Hearing Children (NHC) | Active comparator | Ages 7-17 years, Control Group Receives: Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks |
| Normal Hearing Adults (NHA) | Active comparator | 18+ years, Control Group Receives: Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Visit (Day 1) , Visit week 10
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.
Measured: Baseline Visit (Day 1) , Visit week 10
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.
Measured: Baseline Visit (Day 1) , Visit week 10
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
Measured: Baseline Visit (Day 1) , Visit week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start12 Jul 2018
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Landsberger, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203302
- Sponsor's protocol ID
- 18-00437
- Status last verified
- Mar 2026
- First submitted
- 10 Jan 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Coding Strategies for Children With Cochlear Implants
- ClinicalTrials.gov ID
- NCT05203302
- Acronym / sponsor ID
- 18-00437
- Conditions
- Deafness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Late Adult Cochlear Implant (LateAdultCI) | Experimental | Other: Single-Electrode Pulse Train, Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks, Other: Sound coding strategy.Post-lingually implanted adults, 18+ years |
| Early Child Cochlear Implant (EarlyChildCI) | Experimental | Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks, Other: Sound coding strategy., Other: Electric-only spectral resolutionEarly implanted children, ages 7-17 years |
| Early Adult Cochlear Implant (EarlyAdultCI) | Experimental | Other: Single-Electrode Pulse Train, Other: Sound coding strategy.Early implanted adults, ages 18 to 35 years |
| Cochlear Implant (CI) | Experimental | Other: Electric-only spectral resolutionCI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral) |
| Normal Hearing Children (NHC) | Active comparator | Other: Modulation Detection Threshold (MDT) and Gap Detection TasksAges 7-17 years, Control Group |
| Normal Hearing Adults (NHA) | Active comparator | Other: Modulation Detection Threshold (MDT) and Gap Detection Tasks18+ years, Control Group |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Any child implanted post-lingually
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Electrode Pulse TrainAIM 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. | Other | Early Adult Cochlear Implant (EarlyAdultCI), Late Adult Cochlear Implant (LateAdultCI) |
| Modulation Detection Threshold (MDT) and Gap Detection TasksAIM 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 | Early Child Cochlear Implant (EarlyChildCI), Late Adult Cochlear Implant (LateAdultCI), Normal Hearing Adults (NHA), Normal Hearing Children (NHC) |
| 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 | Early Adult Cochlear Implant (EarlyAdultCI), Early Child Cochlear Implant (EarlyChildCI), Late Adult Cochlear Implant (LateAdultCI) |
| Electric-only spectral resolutionAim 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. | Other | Cochlear Implant (CI), Early Child Cochlear Implant (EarlyChildCI) |
Primary outcome
Change in loudness growth in Cochlear Implant participants
Time frame: Baseline Visit (Day 1) , Visit week 10
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.
Change in temporal resolution in Cochlear implant participants
Time frame: Baseline Visit (Day 1) , Visit week 10
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.
Change in spectral resolution in Cochlear implant participants
Time frame: Baseline Visit (Day 1) , Visit week 10
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.
Difference in performance between the reduced channel map and the full map
Time frame: Baseline Visit (Day 1) , Visit week 10
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David M Landsberger, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Electrode Pulse Train, Modulation Detection Threshold (MDT) and Gap Detection Tasks and Sound coding strategy. in people with Deafness, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David M Landsberger, MD (212-263-8455, david.landsberger@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in loudness growth in Cochlear Implant participants (time frame: Baseline Visit (Day 1) , Visit week 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.