Clinical trial NCT05867173: Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
Official title: Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deafness
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: University of Washington
First posted: 2023-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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

Primary outcomes:
measure: Slopes of the spread of excitation of the electrically evoked compound action potential responses
timeFrame: Baseline
measure: Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.
timeFrame: Baseline
measure: Changes in vowel identification scores
timeFrame: Baseline and weekly for 10 weeks after the intervention
measure: Changes in sentence recognition scores
timeFrame: Baseline and weekly for 10 weeks after the intervention
measure: Changes in speech-gap detection thresholds
timeFrame: Baseline and weekly for 10 weeks after the intervention
measure: Changes in phoneme discrimination scores
timeFrame: Baseline and weekly for 10 weeks after the intervention
measure: Changes in time (weeks) with programming strategy
timeFrame: Baseline and weekly for 10 weeks after the intervention
Secondary outcomes:
measure: Age
timeFrame: Age at baseline
measure: Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores
timeFrame: Baseline, and weekly for 10 weeks after the intervention
measure: Macarthur-Bates vocabulary inventory scores
timeFrame: Baseline, and weekly for 10 weeks after the intervention
measure: Hearing quality of life (HEARQL) scores
timeFrame: Baseline, 5 weeks, and 10 weeks after the intervention
measure: Sound quality questionnaire
timeFrame: Baseline and weekly for 10 weeks after the intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass Eye and Ear
state: Massachusetts
city: Waltham
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear
name: Julie Arenberg
role: PRINCIPAL_INVESTIGATOR
References: