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Cochlear Implant Speech in Noise Processing

O15-PET Imaging of Cochlear Implant Speech in Noise Processing

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06860152
Enrollment
150
Registered
2025-03-05
Start date
2024-11-14
Completion date
2028-03-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Adult-Onset, Hearing Loss, Extreme, Speech Intelligibility

Brief summary

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

DEVICECochlear implant

Cochlear implant

Sponsors

Craig D. Workman, PhD
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
To identify the cortical bases for speech-in-noise understanding in cochlear implant usersBasline VisitPET imaging will be used to identify the brain regions for listeners ability to recognize speech in noise at different signal-to-noise ratios.

Countries

United States

Contacts

CONTACTCraig D Workman, PhD
craig-workman@uiowa.edu(319) 384-5468
PRINCIPAL_INVESTIGATORCraig D. Workman, PhD

University of Iowa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026