Novel Coding Strategies for Children With Cochlear Implants
Primary Purpose
Deafness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-Electrode Pulse Train
Modulation Detection Threshold (MDT) and Gap Detection Tasks
Sound coding strategy.
Electric-only spectral resolution
Sponsored by
About this trial
This is an interventional basic science trial for Deafness
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
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Late Adult Cochlear Implant (LateAdultCI)
Early Child Cochlear Implant (EarlyChildCI)
Early Adult Cochlear Implant (EarlyAdultCI)
Cochlear Implant (CI)
Normal Hearing Children (NHC)
Normal Hearing Adults (NHA)
Arm Description
Post-lingually implanted adults, 18+ years
Early implanted children, ages 7-17 years
Early implanted adults, ages 18 to 35 years
CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral)
Ages 7-17 years, Control Group
18+ years, Control Group
Outcomes
Primary Outcome Measures
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.
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.
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05203302
Brief Title
Novel Coding Strategies for Children With Cochlear Implants
Official Title
Novel Coding Strategies for Children With Cochlear Implants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Late Adult Cochlear Implant (LateAdultCI)
Arm Type
Experimental
Arm Description
Post-lingually implanted adults, 18+ years
Arm Title
Early Child Cochlear Implant (EarlyChildCI)
Arm Type
Experimental
Arm Description
Early implanted children, ages 7-17 years
Arm Title
Early Adult Cochlear Implant (EarlyAdultCI)
Arm Type
Experimental
Arm Description
Early implanted adults, ages 18 to 35 years
Arm Title
Cochlear Implant (CI)
Arm Type
Experimental
Arm Description
CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral)
Arm Title
Normal Hearing Children (NHC)
Arm Type
Active Comparator
Arm Description
Ages 7-17 years, Control Group
Arm Title
Normal Hearing Adults (NHA)
Arm Type
Active Comparator
Arm Description
18+ years, Control Group
Intervention Type
Other
Intervention Name(s)
Single-Electrode Pulse Train
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Modulation Detection Threshold (MDT) and Gap Detection Tasks
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sound coding strategy.
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Electric-only spectral resolution
Intervention Description
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 Information:
Title
Change in loudness growth in Cochlear Implant participants
Description
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 10
Title
Change in temporal resolution in Cochlear implant participants
Description
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 10
Title
Change in spectral resolution in Cochlear implant participants
Description
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 10
Title
Difference in performance between the reduced channel map and the full map
Description
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 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David M Landsberger, MD
Phone
212-263-8455
Email
david.landsberger@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Stupak
Phone
646-501-4153
Email
natalia.stupak@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Landsberger, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M Landsberger, MD
Phone
212-263-8455
Email
david.landsberger@nyulangone.org
First Name & Middle Initial & Last Name & Degree
David M Landsberger, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. The investigator who proposed to use the data. The investigator who proposed to use the data.
IPD Sharing Access Criteria
Upon reasonable request.Requests should be directed to natalia.stupak@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Novel Coding Strategies for Children With Cochlear Implants
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