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Diagnostic Auditory Tests for Hearing Loss in Cochlear Implantees
N/A
Waitlist Available
Led By Matthew J. Goupell, PhD
Research Sponsored by University of Maryland, College Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Post-lingual onset of deafness
post-lingual onset of deafness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant.
Awards & highlights
Study Summary
This trial investigates why some older adults with cochlear implants benefit more from the device than others. It looks at things like age, overall health, and where the implant is placed in the ear. Different types of input (like simple sounds or spoken sentences) are used to examine these questions.
Who is the study for?
This trial is for older adults with post-lingual deafness who have been using a Cochlear-brand cochlear implant for over a year. Candidates should have normal to moderate hearing loss and must not be pregnant, use non-Cochlear implants, or have severe hearing loss or neurological disorders.Check my eligibility
What is being tested?
The study tests how aging, health of auditory pathways, and the placement of cochlear implant electrodes affect speech perception in older users. It involves diagnostic tests on cochlear implant function and auditory processing using various sounds.See study design
What are the potential side effects?
Since this trial focuses on diagnostic testing rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing testing equipment or fatigue from participating in the study sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I became deaf after learning to speak.
Select...
I became deaf after learning to speak.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: post-treatment - after at least 1 year use of a cochlear implant if ci user. not collected from nh listeners. this measure will be collected once within a 6-month time period for each participant.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amplitude modulation detection performance
Perceptual amplitude discrimination thresholds
Perceptual duration discrimination thresholds
+3 moreSecondary outcome measures
Cortical auditory evoked potential - N1 and P2 amplitude
Cortical auditory evoked potential - N1 and P2 latency
Electrically evoked compound action potential (ECAP)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Enrolled Participants - Older adults with cochlear implantsExperimental Treatment1 Intervention
Individuals who already use at least one cochlear implant.
Group II: Enrolled Participants - Adults with typical hearingExperimental Treatment1 Intervention
Control group to provide baseline or comparison data
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cochlear implants treat cochlear hearing loss by electrically stimulating the auditory nerve, bypassing damaged hair cells in the cochlea. This direct activation of the auditory nerve allows the brain to perceive sound, making it a vital option for patients whose hearing loss is too severe for traditional hearing aids to be effective.
This mechanism is essential as it provides a means to restore hearing function, significantly improving the quality of life for individuals with profound hearing loss.
[Biological therapies in otology. German version].
[Biological therapies in otology. German version].
Find a Location
Who is running the clinical trial?
Vanderbilt UniversityOTHER
705 Previous Clinical Trials
6,143,123 Total Patients Enrolled
University of Maryland, College ParkLead Sponsor
157 Previous Clinical Trials
45,815 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
331 Previous Clinical Trials
178,181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of neurological disorders.I became deaf after learning to speak.You have normal or slightly reduced hearing, or mild to moderate hearing loss.You have a cochlear implant in one or both ears.You are not able to speak using words.I have severe hearing loss.You had surgery to implant something after the year 2004.You have some hearing ability without using a hearing aid at certain frequencies.You have any other known disability or brain-related condition.You have Cochlear-brand implants.You have received a cochlear implant made by the brand Cochlear.You have a cochlear implant in one or both ears.You have had a cochlear implant for at least 1 year.I have had problems with my middle ear.You had surgery to implant something after the year 2004.I became deaf after learning to speak.
Research Study Groups:
This trial has the following groups:- Group 1: Enrolled Participants - Older adults with cochlear implants
- Group 2: Enrolled Participants - Adults with typical hearing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cochlear Hearing Loss Patient Testimony for trial: Trial Name: NCT05554692 — N/A
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