Cochlear Implant Speech in Noise Processing

NCT06860152 | Recruiting

• 1 other identifier: 202403834
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cochlear implant

EXPERIMENTAL

Experienced (greater than 1 year) cochlear implant recipients

Device: Cochlear implant

Age-typical hearing control

NO INTERVENTION

Age-matched, age-typical (normal) hearing control participants

Interventions

Cochlear implant DEVICE

Cochlear implant

Cochlear implant

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phillip Gander: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss; Speech Intelligibility; Deafness

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Speech; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Phillip E. Gander, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip Gander, PhD

CONTACT

319-467-7479; phillip-gander@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: November 14, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)