Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
ConditionDeafness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorMassachusetts Eye and Ear Infirmary
About this trial
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
This trial accepts healthy volunteersQualifiers
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 at least 3 months old
Disqualifiers
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
Inability to provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Experimental Speech Processing Strategy
Other interventionPatient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Performance Assessed with Experimental Sound Processing StrategyExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Group C: Experimental ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
Changes in vowel identification scores
Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.
Time frame
Baseline and weekly for 10 weeks after the intervention4
Changes in sentence recognition scores
Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.
Time frame
Baseline and weekly for 10 weeks after the interventionSecondary outcomes
1
Age
A secondary age analysis on all outcome measures will be applied.
Time frame
Age at baseline2
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.
Time frame
Baseline, and weekly for 10 weeks after the intervention3
Macarthur-Bates vocabulary inventory scores
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 intervention4
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
Time frame
Baseline, 5 weeks, and 10 weeks after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts Eye and Ear Infirmary
Lead sponsor
Boston Children's Hospital
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov