Recruiting

Cochlear Implant

Sponsor:

Craig D. Workman, PhD

Code:

NCT06860152

Conditions

Hearing Loss, Adult-Onset

Speech Intelligibility

Hearing Loss, Extreme

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cochlear implant

Study Details

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

Study ID

NCT06860152

Start date

Nov 14, 2024

Status verified date

May, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cochlear implant

Experienced (greater than 1 year) cochlear implant recipients

no intervention: Age-typical hearing control

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

Interventions

Cochlear implant

Cochlear implant

Primary outcome measure

  • To identify the cortical bases for speech-in-noise understanding in cochlear implant users [ Time Frame: Basline Visit ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

Craig D. Workman, PhD

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Craig D. Workman, PhD on 2026-05-14.