NCT05867173 Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
| NCT ID | NCT05867173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Deafness |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-09-16 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-09-16 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 3 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
Contact & Investigator
Julie Arenberg
PRINCIPAL INVESTIGATOR
Massachusetts Eye and Ear
Frequently Asked Questions
Who can join the NCT05867173 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, studying Deafness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05867173 currently recruiting?
Yes, NCT05867173 is actively recruiting participants. Contact the research team at julie_arenberg@meei.harvard.edu for enrollment information.
Where is the NCT05867173 trial being conducted?
This trial is being conducted at Boston, United States, Waltham, United States.
Who is sponsoring the NCT05867173 clinical trial?
NCT05867173 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Julie Arenberg at Massachusetts Eye and Ear. The trial plans to enroll 200 participants.