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Recruiting NCT05867173

Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

No phase Interventional Deafness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental Speech Processing Strategy.
Who it may be relevant to
Registry conditions: Deafness. Basic parameters: from 3 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners

Overview

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.

Interventions

  • Other Experimental Speech Processing Strategy
    Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.

Primary outcome measures

  • Slopes of the spread of excitation of the electrically evoked compound action potential responses [Time frame: Baseline]
  • Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves. [Time frame: Baseline]
  • Changes in vowel identification scores [Time frame: Baseline and weekly for 10 weeks after the intervention]
  • Changes in sentence recognition scores [Time frame: Baseline and weekly for 10 weeks after the intervention]
  • Changes in speech-gap detection thresholds [Time frame: Baseline and weekly for 10 weeks after the intervention]
  • Changes in phoneme discrimination scores [Time frame: Baseline and weekly for 10 weeks after the intervention]
  • Changes in time (weeks) with programming strategy [Time frame: Baseline and weekly for 10 weeks after the intervention]
Secondary outcome measures (5)
  • Age [Time frame: Age at baseline]
  • Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores [Time frame: Baseline, and weekly for 10 weeks after the intervention]
  • Macarthur-Bates vocabulary inventory scores [Time frame: Baseline, and weekly for 10 weeks after the intervention]
  • Hearing quality of life (HEARQL) scores [Time frame: Baseline, 5 weeks, and 10 weeks after the intervention]
  • Sound quality questionnaire [Time frame: Baseline and weekly for 10 weeks after the intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Other

Study locations

United States · 2 centers
  • Mass Eye and Ear — Boston
  • Boston Children's Hospital — Waltham

Identifiers

NCT: NCT05867173 · MGB_2019P000239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗