Back to resultsPerceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
Primary Purpose
Deafness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Montreal Cognitive Assessment (MoCA)
Detection Threshold Testing
Psychophysical Testing
Speech Perception Testing
Telemetry Recordings
Sponsored by
About this trial
This is an interventional other trial for Deafness
Eligibility Criteria
Inclusion Criteria: Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria Adult at least 18 years old Native speakers of American English Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL CHILDREN Inclusion Criteria Children at least 6 months old Native speakers of American English Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted. Exclusion Criteria: Exclusion for all Cochlear Implant Subjects: Inability to provide informed consent Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device Unable to carry out the study protocol or tasks required in the study Exclusion for all Normal Hearing Subjects: Inability to provide informed consent Hearing loss, or significant history of hearing related issues Unable to carry out the study protocol or tasks required in the study
Sites / Locations
- Mass General BrighamRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention to assess CI
Arm Description
To develop new programming strategies for individuals that will improve performance for a wider range of cochlear implant people
Outcomes
Primary Outcome Measures
Slopes of the spread of excitation of the electrically evoked compound action potential responses
Responses of the auditory nerve can be measured directly from the cochlear implant using software developed by the implant manufacturer. By changing the distance between two electrodes, we can quantify the spread of activation in the cochlea.
Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.
A behavioral test designed to measure how spectral information is processed in the auditory system. By changing the relationship between a masker and target signal, we can assess resolution.
Changes in vowel identification scores
Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.
Changes in sentence recognition scores
Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.
Changes in speech-gap detection thresholds
Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.
Changes in phoneme discrimination scores
Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.
Changes in time (weeks) with programming strategy
Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed.
Secondary Outcome Measures
Age
A secondary age analysis on all outcome measures will be applied.
Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores
The IT-MAIS is a study-team-guided parental report about how infants and toddlers are responding to sound.
Macarthur-Bates vocabulary inventory scores
This test allows the study team and parents to monitor speech and language development, specifically new word learning.
Hearing quality of life (HEARQL) scores
The HEAR-QL is a self-assessment test normed for children to assess how they hear in everyday life with different interventions
Sound quality questionnaire
Participants will be asked to rate sound quality with different interventions in comparison to their everyday listening on a 7-point scale (from minus 3 - much worse, up to plus 3 - much better, 0 is the same)
Full Information
NCT ID
NCT05867173
First Posted
February 27, 2023
Last Updated
May 23, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
Boston Children's Hospital, University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT05867173
Brief Title
Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
Official Title
Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
Boston Children's Hospital, University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention to assess CI
Arm Type
Experimental
Arm Description
To develop new programming strategies for individuals that will improve performance for a wider range of cochlear implant people
Intervention Type
Other
Intervention Name(s)
Montreal Cognitive Assessment (MoCA)
Intervention Description
Subjects will be asked to complete this one-page cognitive test assesses short-term memory recall and attention. This test takes approximately 10 minutes.
Intervention Type
Other
Intervention Name(s)
Detection Threshold Testing
Intervention Description
Subjects will be asked to listen for the softest sound they can hear ("threshold') with different electrode configurations
Intervention Type
Other
Intervention Name(s)
Psychophysical Testing
Intervention Description
Subjects will be asked to determine the difference between different types of sounds, such as those that vary in pitch and/or volume. Sometimes they will be asked to judge the sound quality of sounds that have very small differences, or make loudness judgments and comparisons.
Intervention Type
Other
Intervention Name(s)
Speech Perception Testing
Intervention Description
Subjects will be asked to listen to words and sentences in quiet and/or in the presence of background noise. For this task they will be asked to repeat the words or sentences following its presentation or use the computer mouse to respond.
Intervention Type
Other
Intervention Name(s)
Telemetry Recordings
Intervention Description
Subjects who wear a cochlear implant, for each cochlear implant channel or pair of channels, measurements will be made from other available electrodes in their implant.
Primary Outcome Measure Information:
Title
Slopes of the spread of excitation of the electrically evoked compound action potential responses
Description
Responses of the auditory nerve can be measured directly from the cochlear implant using software developed by the implant manufacturer. By changing the distance between two electrodes, we can quantify the spread of activation in the cochlea.
Time Frame
Baseline
Title
Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.
Description
A behavioral test designed to measure how spectral information is processed in the auditory system. By changing the relationship between a masker and target signal, we can assess resolution.
Time Frame
Baseline
Title
Changes in vowel identification scores
Description
Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.
Time Frame
Baseline and weekly for 10 weeks after the intervention
Title
Changes in sentence recognition scores
Description
Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.
Time Frame
Baseline and weekly for 10 weeks after the intervention
Title
Changes in speech-gap detection thresholds
Description
Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.
Time Frame
Baseline and weekly for 10 weeks after the intervention
Title
Changes in phoneme discrimination scores
Description
Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.
Time Frame
Baseline and weekly for 10 weeks after the intervention
Title
Changes in time (weeks) with programming strategy
Description
Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed.
Time Frame
Baseline and weekly for 10 weeks after the intervention
Secondary Outcome Measure Information:
Title
Age
Description
A secondary age analysis on all outcome measures will be applied.
Time Frame
Age at baseline
Title
Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores
Description
The IT-MAIS is a study-team-guided parental report about how infants and toddlers are responding to sound.
Time Frame
Baseline, and weekly for 10 weeks after the intervention
Title
Macarthur-Bates vocabulary inventory scores
Description
This test allows the study team and parents to monitor speech and language development, specifically new word learning.
Time Frame
Baseline, and weekly for 10 weeks after the intervention
Title
Hearing quality of life (HEARQL) scores
Description
The HEAR-QL is a self-assessment test normed for children to assess how they hear in everyday life with different interventions
Time Frame
Baseline, 5 weeks, and 10 weeks after the intervention
Title
Sound quality questionnaire
Description
Participants will be asked to rate sound quality with different interventions in comparison to their everyday listening on a 7-point scale (from minus 3 - much worse, up to plus 3 - much better, 0 is the same)
Time Frame
Baseline and weekly for 10 weeks after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria
Adult at least 18 years old
Native speakers of American English
Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL
CHILDREN Inclusion Criteria
Children at least 6 months old
Native speakers of American English
Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL
For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.
Exclusion Criteria:
Exclusion for all Cochlear Implant Subjects:
Inability to provide informed consent
Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device
Unable to carry out the study protocol or tasks required in the study
Exclusion for all Normal Hearing Subjects:
Inability to provide informed consent
Hearing loss, or significant history of hearing related issues
Unable to carry out the study protocol or tasks required in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Arenberg
Phone
617-807-7904
Email
julie_arenberg@meei.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Arenberg
Organizational Affiliation
Massachusetts Eye and Ear
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mass General Brigham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Arenberg
Phone
617-807-7904
Email
julie_arenberg@meei.harvard.edu
First Name & Middle Initial & Last Name & Degree
Julie Arenberg
12. IPD Sharing Statement
Learn more about this trial
Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
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