Understanding how cochlear implant users hear speech in noise
O15-PET Imaging of Cochlear Implant Speech in Noise Processing
This study is trying to see how cochlear implant users hear speech in noisy places by looking at their brain activity compared to people with normal hearing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06860152 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the neural mechanisms that enable cochlear implant users to detect speech in noisy environments. By utilizing PET neuroimaging, researchers will examine brain activity related to speech perception in various cochlear implant users, comparing their responses to those of age-matched individuals with typical hearing. The study will involve a single session of auditory stimulation while monitoring brain blood flow using a radioactive tracer. The findings could help identify factors that predict successful speech understanding in challenging listening conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 99 with a cochlear implant activated for over a year and severe hearing loss after age 16.
Not a fit: Patients with conditions such as seizure disorders, head injuries, or other significant neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cochlear implant technology and strategies for enhancing speech intelligibility in noisy environments for users.
How similar studies have performed: While studies on cochlear implants exist, this specific approach using PET neuroimaging to understand speech perception in noise is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Cochlear Implant subjects (enrollment is planned at N=120) - Inclusion criteria: 1. Between 18 and 99 years of age. 2. Have a cochlear implant activated for more than one year. 3. Eligible for research under the Iowa Cochlear Implant Project VIII. 4. Ability to understand and willingness to sign a written informed consent document. 5. Severe hearing loss after age 16. Normal Hearing subjects (enrollment is planned at N=30) - Inclusion criteria: 1. Between 18 and 99 years of age. 2. Have age typical hearing. 3. Eligible for research under the Iowa Cochlear Implant Project VIII. 4. Ability to understand and willingness to sign a written informed consent document. Exclusion criteria (all groups): 1. Medical history includes seizure disorder, head injury, neurologic, metabolic, cardiovascular disease, or previous cerebrovascular event (unless approved by PI). 2. Female self-reporting pregnancy. A urine pregnancy test will be performed prior to injection of the radiopharmaceutical. 3. Currently taking medications which may affect cerebral blood flow (e.g., papaverine, ginkgo biloba, acetazolamide). 4. Uncontrolled intercurrent illness that would limit compliance with study requirements per investigator.
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Phillip E. Gander, PhD — University of Iowa
- Study coordinator: Phillip Gander, PhD
- Email: phillip-gander@uiowa.edu
- Phone: 319-467-7479
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.