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Cochlear Implant Programming for Hearing Loss

N/A
Recruiting
Led By Julie Arenberg
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ADULTS: 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 weeks, and 10 weeks after the intervention

Summary

This trial aims to improve cochlear implant outcomes for adults & children by understanding how they affect the auditory system & testing new methods of programming. Advancing our knowledge of how the deafened auditory system develops will improve hearing outcomes.

Who is the study for?
This trial is for children and adults with severe hearing loss who have cochlear implants from specific manufacturers. Adults must be at least 18, native English speakers, while children can participate from 6 months old. Participants cannot join if they're unable to consent or meet certain protocol criteria like age of hearing loss onset.
What is being tested?
The study aims to understand how cochlear implants affect auditory development and test new programming methods for better speech perception in users. It involves cognitive assessments, threshold and psychophysical testing, speech tests, and telemetry recordings over time.
What are the potential side effects?
Since this trial focuses on testing procedures rather than medications, traditional side effects are not a concern. However, participants may experience fatigue or discomfort during the extensive testing process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older, speak American English, and wear a cochlear implant from Advanced Bionics, Cochlear, or MED-EL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and weekly for 10 weeks after the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and weekly for 10 weeks after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in phoneme discrimination scores
Changes in sentence recognition scores
Changes in speech-gap detection thresholds
+4 more
Secondary study objectives
Age
Hearing quality of life (HEARQL) scores
Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Performance Assessed with Experimental Sound Processing StrategyExperimental Treatment1 Intervention
Patients listening to experimental cochlear implant processing strategy.
Group II: ControlActive Control1 Intervention
Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).
Group III: Experimental ControlPlacebo Group1 Intervention
Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER
1,831 Previous Clinical Trials
1,907,369 Total Patients Enrolled
2 Trials studying Deafness
187 Patients Enrolled for Deafness
Massachusetts Eye and Ear InfirmaryLead Sponsor
111 Previous Clinical Trials
12,659 Total Patients Enrolled
5 Trials studying Deafness
341 Patients Enrolled for Deafness
Boston Children's HospitalOTHER
789 Previous Clinical Trials
5,582,747 Total Patients Enrolled
Julie ArenbergPrincipal InvestigatorMassachusetts Eye and Ear

Media Library

Cochlear Implant Electrode-neuron Interfaces Clinical Trial Eligibility Overview. Trial Name: NCT05867173 — N/A
Deafness Research Study Groups: Experimental Control, Control, Performance Assessed with Experimental Sound Processing Strategy
Deafness Clinical Trial 2023: Cochlear Implant Electrode-neuron Interfaces Highlights & Side Effects. Trial Name: NCT05867173 — N/A
Cochlear Implant Electrode-neuron Interfaces 2023 Treatment Timeline for Medical Study. Trial Name: NCT05867173 — N/A
~100 spots leftby Mar 2027
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