Noninvasive ear stimulation to improve hearing speech in noisy places
Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07176936 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gainesville, Florida
- UF Health at the University of Florida — Gainesville, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.