Hearing Loss, Adult-OnsetNCT06860152
Cochlear Implant Speech in Noise Processing
A study testing Cochlear implant in people with Hearing Loss, Adult-Onset and Speech Intelligibility, run by Craig D. Workman, PhD at 1 site in United States.
Trial summary
The study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hearing Loss, Adult-Onset, Speech Intelligibility, Hearing Loss, Extreme
- What is being tested?
- Cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Craig D. Workman, PhD, 319-384-5468, craig-workman@uiowa.edu
About this study
Official title: 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.
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.
- Being tested
- Cochlear implant
- Medical subject headings
- Hearing Loss, Speech Intelligibility, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
Cochlear implant
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant | Experimental | Experienced (greater than 1 year) cochlear implant recipients Receives: Device: Cochlear implant |
| Age-typical hearing control | No intervention | Age-matched, age-typical (normal) hearing control participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Basline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start14 Nov 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Adult-OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig D. Workman, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Craig D. Workman, PhD, University of Iowa
- Investigators
- Craig D. Workman, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860152
- Sponsor's protocol ID
- 202403834
- Status last verified
- May 2026
- First submitted
- 27 Feb 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- O15-PET Imaging of Cochlear Implant Speech in Noise Processing
- ClinicalTrials.gov ID
- NCT06860152
- Acronym / sponsor ID
- 202403834
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Craig D. Workman, PhDUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant | Experimental | Device: Cochlear implantExperienced (greater than 1 year) cochlear implant recipients |
| Age-typical hearing control | No intervention | –Age-matched, age-typical (normal) hearing control participants |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implantCochlear implant | Device | Cochlear implant |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Craig D. Workman, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant in people with Hearing Loss, Adult-Onset and Speech Intelligibility, run by Craig D. Workman, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig D Workman, PhD ((319) 384-5468, craig-workman@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the cortical bases for speech-in-noise understanding in cochlear implant users (time frame: Basline Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.