Cochlear Implant Speech in Noise Processing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cochlear implant.
- Who it may be relevant to
- Registry conditions: Hearing Loss, Adult-Onset, Speech Intelligibility, Hearing Loss, Extreme. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
O15-PET Imaging of Cochlear Implant Speech in Noise Processing
Overview
The study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments.
Detailed description
Despite the success of a cochlear implant (CI) for providing or improving hearing ability for people with severe hearing loss, everyday conversations in background noise are still the main clinical complaint. The goal of this study is to understand the neural mechanisms by which listeners with a CI detect speech in noisy environments, and to understand how these mechanisms differ across a variety of CI listeners, in order to determine what variables are most relevant for predicting successful outcome. Therefore the purpose of PET neuroimaging in this study is to find the brain regions that relate to speech in noise effort using PET during auditory stimulation on a single session across a variety of CI users with different device configurations. An age-matched typical hearing control group provides a baseline for comparison. PET neuroimaging will be performed using a radioactive form of water, O-15 (an investigational agent), that will be injected into the body to examine brain blood flow using a PET/CT scanner.
Interventions
- Device Cochlear implant
Cochlear implant
Primary outcome measures
- To identify the cortical bases for speech-in-noise understanding in cochlear implant users [Time frame: Basline Visit]
Eligibility criteria
Cochlear Implant subjects (enrollment is planned at N=120) - Inclusion criteria:
- Between 18 and 99 years of age.
- Have a cochlear implant activated for more than one year.
- Eligible for research under the Iowa Cochlear Implant Project VIII.
- Ability to understand and willingness to sign a written informed consent document.
- Severe hearing loss after age 16.
Normal Hearing subjects (enrollment is planned at N=30) - Inclusion criteria:
- Between 18 and 99 years of age.
- Have age typical hearing.
- Eligible for research under the Iowa Cochlear Implant Project VIII.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion criteria (all groups):
- Medical history includes seizure disorder, head injury, neurologic, metabolic, cardiovascular disease, or previous cerebrovascular event (unless approved by PI).
- Female self-reporting pregnancy. A urine pregnancy test will be performed prior to injection of the radiopharmaceutical.
- Currently taking medications which may affect cerebral blood flow (e.g., papaverine, ginkgo biloba, acetazolamide).
- Uncontrolled intercurrent illness that would limit compliance with study requirements per investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Identifiers
NCT: NCT06860152 · 202403834