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RecruitingNCT06860152Updated May 14, 2026

Cochlear Implant Speech in Noise Processing

An interventional study of Cochlear implant in Hearing Loss, Adult-Onset, Speech Intelligibility and Hearing Loss, Extreme, sponsored by Craig D. Workman, PhD. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Primary conditionDeafnessRegistry: Hearing LossReclassifiedWhy we changed it
Registry
Hearing Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Deafness
Why
  1. The study's listed conditions name Deafness, a narrower term within Hearing Loss.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Craig D. Workman, PhD · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2024, registered Feb 2025).
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Browse trials for

03

In context

Deafness Reclassified

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's planned enrollment of 150 is above the median of 43 across 106 interventional studies indexed under Deafness.

Browse Deafness studies →

Lead sponsor

This is the only study on the registry with Craig D. Workman, PhD as lead sponsor.

Compared within Deafness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Cochlear implant

    Experienced (greater than 1 year) cochlear implant recipients

    Device: Cochlear implant

  • No intervention
    Age-typical hearing control

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

Interventions

  • DeviceCochlear implant

    Cochlear implant

06

What researchers measure

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.

    Time frame: Basline Visit

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Mar 2028, 40 months after the start.

Of 50 non-industry interventional studies with no phase under Deafness, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20. This study's planned 40 months is below that.

Counting every sponsor, half of 58 studies reached it within 31 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2025
First posted
Mar 5, 2025
StartActual
Nov 14, 2024
Primary completionEst.
Mar 31, 2028
CompletionEst.
Mar 31, 2028
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06860152
Lead sponsor
Craig D. Workman, PhD
Responsible party
Craig D. Workman, PhD (Principal Investigator, University of Iowa) — Sponsor-investigator
First posted
Mar 5, 2025
Start date
Nov 14, 2024
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
May 14, 2026

Study contacts

Craig D Workman, PhD
Contact
craig-workman@uiowa.edu
(319) 384-5468
Craig D. Workman, PhD
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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