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Recruiting

NCT Number: NCT06860152

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Craig D. Workman, PhD

CONTACT

[email protected]

319-384-5468

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cochlear Implant

Device

Cochlear implant

Primary outcomes

  1. To identify the cortical bases for speech-in-noise understanding in cochlear implant users

    Time frame: Basline Visit

    PET imaging will be used to identify the brain regions for listeners ability to recognize speech in noise at different signal-to-noise ratios.

Study contacts

Contact information is provided by the study sponsor or research team.

Craig D Workman, PhD

CONTACT

[email protected]

(319) 384-5468

Sponsors and collaborators

Lead sponsor

Craig D. Workman, PhD

Other

Registry information

Official study title

O15-PET Imaging of Cochlear Implant Speech in Noise Processing

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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