Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT05867173
Status
Recruiting
Apply to this trial

Conditions

  • Deafness

Eligibility Criteria

Sex
ALL
Age
3 Months - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 16, 2022
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Performance Assessed with Experimental Sound Processing Strategy
    Patients listening to experimental cochlear implant processing strategy.
  • No Intervention: Control
    Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).
  • Sham Comparator: Experimental Control
    Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.

Primary Outcome Measure

Slopes of the spread of excitation of the electrically evoked compound action potential responses [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mass Eye and EarBostonMassachusetts02114
Julie Arenberg
[email protected]
617-807-7904
Julie Arenberg (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalWalthamMassachusetts02453
Amanda Griffin
[email protected]
781-216-3657
Amanda Griffin (PRINCIPAL_INVESTIGATOR)

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By research site
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