Traumatic Brain InjuryNCT07176936
Improving Speech in Noise Using Noninvasive Stimulation
A study testing Cymba Conchae stimulation and Earlobe stimulation in people with Traumatic Brain Injury and Hearing Loss, run by University of Florida at 1 site in United States.
Trial summary
Traumatic brain injury, a common injury in military service personnel, often leads to poor processing of speech in noisy environments. The goal of the current study is to better understand the brain basis for this difficulty and evaluate a new approach to improving speech in noise perception. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Hearing Loss
- What is being tested?
- Cymba Conchae stimulation and Earlobe stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2026to 31 Aug 2027
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25-55 years old
- Proficiency in English
- TBI group: history of traumatic brain injury by blast or physical trauma
- Normal hearing group: no history of traumatic brain injury
Who cannot join
- Other neurological diseases or related conditions will be excluded (e.g., large vessel stroke, seizures). We will exclude patients with severe medical diseases that may be associated with impaired cognition (e.g., heart failure, dialysis dependent kidney disease, brain cancer). Further, psychiatric diseases that are unlikely to be related to trauma will be excluded (e.g., schizophrenia).
- Patients with histories of severe psychiatric disease prior to trauma exposure will be excluded.
- Current illicit or prescription drug abuse (within the last two months)
- Any taVNS contraindication, including but not limited to the presence of unremovable metal in the left ear, known heart conditions, medications that influence neurotransmitters thought to be critical for vagus nerve stimulation (norepinephrine, acetylcholine, and serotonin), or implanted medical devices such as a pacemaker.
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
UF Health at the University of Florida
Gainesville, Florida, 32610
Tracy Centanni, Ph.D., 352-294-8675, tracy.centanni@phhp.ufl.edu
John Williamson, Ph.D., john.williamson@ufl.edu
About this study
Official title: Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception
Traumatic brain injury, a common injury in military service personnel, often leads to poor processing of speech in noisy environments. The goal of the current study is to better understand the brain basis for this difficulty and evaluate a new approach to improving speech in noise perception.
- Conditions
- Traumatic Brain Injury, Hearing Loss
- Being tested
- Cymba Conchae stimulation, Earlobe stimulation
- Medical subject headings
- Brain Injuries, Traumatic, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cymba Conchae stimulationDevice
Also called Treatment A
Electrical stimulation applied to the cymba conchae region of the outer ear
Earlobe stimulationDevice
Also called Treatment B
Electrical stimulation applied to the earlobe region of the outer ear
| Study group | Role | What they receive |
|---|---|---|
| Treatment A vs Treatment B | Other | Participants will receive the stimulation at location A and then receive stimulation at location B, both on the outer ear. Receives: Device: Cymba Conchae stimulation; Device: Earlobe stimulation |
| Treatment B then Treatment A | Other | Participants will receive the stimulation at location B and then receive stimulation at location A, both on the outer ear. Receives: Device: Cymba Conchae stimulation; Device: Earlobe stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility
quantify attrition as well as frequency and severity of adverse events
Measured: From enrollment to the end of treatment is between 2 days and 2 weeks.
Secondary outcomes (2)
Speech in Noise performance
Percent correct on a speech in noise perception task when receiving Treatment A compared to Treatment B
Measured: Baseline and one week
Brain response patterns
Pattern of brain response while listening to speech in background noise while receiving Treatment A compared to Treatment B
Measured: Baseline and one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start21 Mar 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176936
- Sponsor's protocol ID
- IRB202500139
- Other IDs
- RH240016
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared at the time of data publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception
- ClinicalTrials.gov ID
- NCT07176936
- Acronym / sponsor ID
- IRB202500139
- Conditions
- Traumatic Brain Injury, Hearing Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 21 Mar 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Sep 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.
Traumatic brain injury, a common injury in military service personnel, often leads to poor processing of speech in noisy environments. The goal of the current study is to better understand the brain basis for this difficulty and evaluate a new approach to improving speech in noise perception.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A vs Treatment B | Other | Device: Cymba Conchae stimulation, Device: Earlobe stimulationParticipants will receive the stimulation at location A and then receive stimulation at location B, both on the outer ear. |
| Treatment B then Treatment A | Other | Device: Cymba Conchae stimulation, Device: Earlobe stimulationParticipants will receive the stimulation at location B and then receive stimulation at location A, both on the outer ear. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 25-55 years old
- Proficiency in English
- TBI group: history of traumatic brain injury by blast or physical trauma
- Normal hearing group: no history of traumatic brain injury
Key exclusion criteria (4 listed)
- Other neurological diseases or related conditions will be excluded (e.g., large vessel stroke, seizures). We will exclude patients with severe medical diseases that may be associated with impaired cognition (e.g., heart failure, dialysis dependent kidney disease, brain cancer). Further, psychiatric diseases that are unlikely to be related to trauma will be excluded (e.g., schizophrenia).
- Patients with histories of severe psychiatric disease prior to trauma exposure will be excluded.
- Current illicit or prescription drug abuse (within the last two months)
- Any taVNS contraindication, including but not limited to the presence of unremovable metal in the left ear, known heart conditions, medications that influence neurotransmitters thought to be critical for vagus nerve stimulation (norepinephrine, acetylcholine, and serotonin), or implanted medical devices such as a pacemaker.
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 |
|---|---|---|
| Cymba Conchae stimulationAlso: Treatment AElectrical stimulation applied to the cymba conchae region of the outer ear | Device | Treatment A vs Treatment B, Treatment B then Treatment A |
| Earlobe stimulationAlso: Treatment BElectrical stimulation applied to the earlobe region of the outer ear | Device | Treatment A vs Treatment B, Treatment B then Treatment A |
Primary outcome
Safety and feasibility
Time frame: From enrollment to the end of treatment is between 2 days and 2 weeks.
quantify attrition as well as frequency and severity of adverse events
2 secondary outcomes
Speech in Noise performance
Time frame: Baseline and one week
Brain response patterns
Time frame: Baseline and one week
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared at the time of data publication
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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.
UF Health at the University of Florida
Gainesville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cymba Conchae stimulation and Earlobe stimulation in people with Traumatic Brain Injury and Hearing Loss, run by University of Florida 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 4 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 27 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and feasibility (time frame: From enrollment to the end of treatment is between 2 days and 2 weeks.). 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 27 Mar 2026.