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Procedure
Personalized Cochlear Implant Mapping for Hearing Loss
N/A
Recruiting
Led By Sumit K Agrawal, MD
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (18 years of age or older) with moderate-to-profound sensorineural hearing loss bilaterally or single-sided deafness (SSD)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-surgery), device activation (~ 1 month post-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation, 1 year post-activation.
Awards & highlights
Study Summary
This trial will help make cochlear implants more effective for recipients by creating personalized pitch-maps tailored to each person's individual ear anatomy.
Who is the study for?
This trial is for adults over 18 with moderate-to-profound sensorineural hearing loss or single-sided deafness, who are native English speakers and approved for cochlear implantation. Participants must be able to do study tasks and return for follow-ups. Those with cognitive issues or failing a mental state exam are excluded.Check my eligibility
What is being tested?
The study compares two methods of programming cochlear implants: the standard generalized pitch-map versus a new patient-specific place-based pitch-map. Patients will be randomly assigned to one of these approaches and tested over time on their ability to recognize pitches and understand speech nuances.See study design
What are the potential side effects?
Since this trial involves non-invasive programming techniques rather than drugs, traditional side effects aren't expected. However, there may be differences in auditory perception between the two mapping strategies that could affect sound quality and speech understanding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with severe hearing loss in both ears or deafness in one ear.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-surgery), device activation (~ 1 month post-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation, 1 year post-activation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-surgery), device activation (~ 1 month post-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation, 1 year post-activation.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Novel Object Recognition Test
Secondary outcome measures
Change in score on self-reported sound localization
Change in score on self-reported sound quality
Change in score on the Aided Sentence (AzBio) Test
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Place-based mapExperimental Treatment1 Intervention
CIs will be mapped according to each participant's unique place-based map using MED-EL MAESTRO fitting software. Participants' audiological performance will be assessed in both the experimental and default programs at activation and at 6 months. At 1-month and 3-month visits, performance will be assessed in the participant's assigned program only. Following the 6-month testing interval, participants will listen to the alternative map than the one they were assigned for 1 additional month. At the 7-month visit, participants will be assessed in both programs. After the 7-month visit, participants will be given the choice to move forward with whichever map they prefer. The final assessment interval will take place at 1-year in the participant's chosen map.
Group II: Default mapActive Control1 Intervention
CIs will be mapped according to the clinical default program using MED-EL MAESTRO fitting software. Participants' audiological performance will be assessed in both the experimental and default programs at activation and at 6 months. At 1-month and 3-month visits, performance will be assessed in the participant's assigned program only. Following the 6-month testing interval, participants will listen to the alternative map for 1 additional month from the one they were randomly assigned. At the 7-month visit, participants will be assessed in both programs. After the 7-month visit, participants will be given the choice to move forward with whichever map they prefer. The final assessment interval will take place at 1-year in the participant's chosen map.
Find a Location
Who is running the clinical trial?
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
56,891 Total Patients Enrolled
University of North CarolinaOTHER
167 Previous Clinical Trials
1,449,597 Total Patients Enrolled
Academic Medical Organization of Southwestern OntarioOTHER
13 Previous Clinical Trials
2,519 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I did not pass a mental fitness test appropriate for my age and education.I can attend all follow-up visits as recommended.I am a native English speaker.You do not have any problems with your memory or thinking.I am an adult with severe hearing loss in both ears or deafness in one ear.
Research Study Groups:
This trial has the following groups:- Group 1: Place-based map
- Group 2: Default map
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being treated with the trial's interventions?
"Affirmative. Clinicaltrials.gov provides evidence that this research initiative, first posted on June 7th 2023, is currently recruiting participants. To date, only 30 patients have been enrolled from a single location."
Answered by AI
Are there still opportunities for new participants in this research?
"Per clinicaltrials.gov, this trial is actively recruiting participants. It was initially published on June 7th 2023 and revised most recently on July 11th 2023."
Answered by AI
Who else is applying?
What site did they apply to?
Western University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I am a cochlear implant candidate concerned about achieving the best possible outcome with the most advanced technology and I appreciate the focus of this study to measure unique ear anatomy for personalized pitch maps.
PatientReceived 1 prior treatment
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