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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05867173
Other study ID # MGB_2019P000239
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 16, 2022
Est. completion date March 31, 2027

Study information

Verified date March 2024
Source Massachusetts Eye and Ear Infirmary
Contact Julie Arenberg
Phone 617-807-7904
Email julie_arenberg@meei.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Montreal Cognitive Assessment (MoCA)
Subjects will be asked to complete this one-page cognitive test assesses short-term memory recall and attention. This test takes approximately 10 minutes.
Detection Threshold Testing
Subjects will be asked to listen for the softest sound they can hear ("threshold') with different electrode configurations
Psychophysical Testing
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.
Speech Perception Testing
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.
Telemetry Recordings
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.

Locations

Country Name City State
United States Mass Eye and Ear Boston Massachusetts
United States Boston Children's Hospital Waltham Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts Eye and Ear Infirmary Boston Children's Hospital, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Primary Changes in vowel identification scores Medial vowel identification performance in background noise. Participants will complete age-appropriate testing. Baseline and weekly for 10 weeks after the intervention
Primary Changes in sentence recognition scores Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing. Baseline and weekly for 10 weeks after the intervention
Primary Changes in speech-gap detection thresholds Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing. Baseline and weekly for 10 weeks after the intervention
Primary Changes in phoneme discrimination scores Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing. Baseline and weekly for 10 weeks after the intervention
Primary 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. Baseline and weekly for 10 weeks after the intervention
Secondary Age A secondary age analysis on all outcome measures will be applied. Age at baseline
Secondary 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. Baseline, and weekly for 10 weeks after the intervention
Secondary Macarthur-Bates vocabulary inventory scores This test allows the study team and parents to monitor speech and language development, specifically new word learning. Baseline, and weekly for 10 weeks after the intervention
Secondary 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 Baseline, 5 weeks, and 10 weeks after the intervention
Secondary 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) Baseline and weekly for 10 weeks after the intervention
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