Recruiting

Speech in Noise

Sponsor:

University of Florida

Code:

NCT07176936

Conditions

Traumatic Brain Injury

Hearing Loss

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Interventions

Cymba Conchae stimulation

Earlobe stimulation

Study Details

Brief 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.

Conditions

Traumatic Brain Injury

Hearing Loss

Study ID

NCT07176936

Start date

Mar 21, 2026

Status verified date

Mar, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Treatment A vs Treatment B

Participants will receive the stimulation at location A and then receive stimulation at location B, both on the outer ear.

other: Treatment B then Treatment A

Participants will receive the stimulation at location B and then receive stimulation at location A, both on the outer ear.

Interventions

Cymba Conchae stimulation

Electrical stimulation applied to the cymba conchae region of the outer ear

Earlobe stimulation

Electrical stimulation applied to the earlobe region of the outer ear

Primary outcome measure

  • Safety and feasibility [ Time Frame: From enrollment to the end of treatment is between 2 days and 2 weeks. ]

Central Contacts and Locations

Locations

UF Health at the University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Tracy Centanni, Ph.D.

352-294-8675tracy.centanni@phhp.ufl.edu

John Williamson, Ph.D.

john.williamson@ufl.edu

Principal Investigator:

Tracy Centanni, Ph.D.

More Information

Sponsor

University of Florida

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by University of Florida on 2026-03-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.