Cochlear Implant Speech in Noise Processing

O15-PET Imaging of Cochlear Implant Speech in Noise Processing

The study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments.

Study Overview

• Status: Recruiting
• Conditions: Speech Intelligibility; Hearing Loss, Adult-Onset; Hearing Loss, Extreme
• Intervention / Treatment: Device: Cochlear implant

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Craig D Workman, PhD; Phone Number: (319) 384-5468; Email: craig-workman@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Craig D. Workman, PhD; Phone Number: 319-384-5468; Email: craig-workman@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cochlear implant; Experienced (greater than 1 year) cochlear implant recipients	Device: Cochlear implant; Cochlear implant
No Intervention: Age-typical hearing control; Age-matched, age-typical (normal) hearing control participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify the cortical bases for speech-in-noise understanding in cochlear implant users	PET imaging will be used to identify the brain regions for listeners ability to recognize speech in noise at different signal-to-noise ratios.	Basline Visit

Collaborators and Investigators

• Sponsor: Craig D. Workman, PhD
• Investigators: Principal Investigator: Craig D. Workman, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Communication; Verbal Behavior; Speech; Hearing Loss; Deafness; Speech Intelligibility; Equipment and Supplies; Electrodes; Electrical Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants; Neural Prostheses; Implantable Neurostimulators; Hearing Aids; Sensory Aids; Cochlear Implants
• Other Study ID Numbers: 202403834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No