Customized cochlear implant programming for better hearing
Performance Comparisons With Default Versus Place-based Maps
NA · Western University, Canada · NCT05558514
This study is testing if a personalized cochlear implant setting can help people hear better compared to the standard settings.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western University, Canada (other) |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05558514 on ClinicalTrials.gov |
What this trial studies
This study aims to improve cochlear implant programming by using a personalized pitch-map based on individual anatomical differences in the cochlea. Participants will be randomized to receive either the standard pitch-map or a customized version designed to better match their unique hearing anatomy. Audiological assessments will be conducted at various intervals to evaluate the effectiveness of the customized mapping in enhancing sound perception and speech recognition. The goal is to address the common issue of place-pitch mismatch experienced by cochlear implant recipients.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate-to-profound sensorineural hearing loss or single-sided deafness who are approved for unilateral cochlear implantation.
Not a fit: Patients with cognitive issues or those who do not meet the study's eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significantly improved hearing outcomes for cochlear implant users.
How similar studies have performed: While the concept of personalized cochlear implant mapping is innovative, similar studies have shown promise in improving hearing outcomes through tailored approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (18 years of age or older) with moderate-to-profound sensorineural hearing loss bilaterally or single-sided deafness (SSD) * Approved by the Cochlear Implant Program at London Health Sciences Centre (LHSC) to undergo unilateral cochlear implantation * Identify as a native English speaker (recorded speech recognition/perception materials are presented in English) * Deny any cognitive issues * Willing and able to participate in study procedures (e.g., unaided testing, speech recognition testing, spatial hearing testing) * Willing and able to return for follow-up visits (same intervals as recommended clinically for routine follow-up) Exclusion Criteria: * Fail the Mini Mental State Examination based on their age and education level
Where this trial is running
London, Ontario
- Western University — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Sumit K Agrawal, MD — Western University
- Study coordinator: Sumit K Agrawal, MD
- Email: sumit.agrawal@lhsc.on.ca
- Phone: 519-663-3568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing Loss, Sensorineural, Cochlear Implants, cochlear implant, pitch map, hearing loss, cochlear implant programming, place-pitch mismatch