Clinical trial Recruiting at 1 site Interventional Ages 25 to 55

Noninvasive ear stimulation to improve hearing speech in noisy places

Official title: Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception

Run by University of Florida · NCT07176936 · Data updated 2026-11-12

This will test whether gentle electrical stimulation of the ear can help people with traumatic brain injury hear speech more clearly in noisy environments.

Quick facts

Study typeInterventional
Ages25 Years to 55 Years
SexAll
Enrollment55 (estimated)
SponsorUniversity of Florida
Academic / other
Locations1 site (Gainesville, Florida)
StatusRecruiting
StartedMarch 21, 2026
Main results expectedJuly 31, 2027
Study endsAugust 31, 2027
Registry record updatedMarch 27, 2026
Trial IDNCT07176936 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 25–55 who are proficient in English and have a history of traumatic brain injury with reported difficulty understanding speech in noisy environments.

Probably not a fit

People without TBI, those with major uncontrolled medical or neurological diseases, certain psychiatric histories, active substance abuse, or contraindications to ear stimulation (for example unremovable metal in the left ear or certain heart conditions) are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare noninvasive stimulation of the cymba conchae (targeting the auricular branch of the vagus nerve) with stimulation of the earlobe as a control to see how each affects speech-in-noise perception. Participants will include adults with a history of traumatic brain injury and a normal-hearing comparison group, all aged 25–55 and proficient in English. Outcomes will focus on behavioral measures of speech-in-noise understanding and related neural markers measured during in-person sessions at UF Health. Safety screening excludes people with significant medical, neurological, or certain psychiatric conditions and those with contraindications to transauricular stimulation.

Why it matters

Potential benefit: If successful, this approach could improve everyday communication for people with TBI-related difficulty hearing speech in noisy places.

How similar studies have gone: Early and small studies of transauricular vagus nerve stimulation for auditory and cognitive effects have shown promising but preliminary results, so the approach is relatively novel and not yet established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

  • UF Health at the University of Florida
    Gainesville, Florida, United States
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.