Improving Speech in Noise Using Noninvasive Stimulation for Traumatic Brain Injury and Hearing Loss

This study is looking into ways to help people who have trouble understanding speech in noisy places, especially after a traumatic brain injury (TBI). Researchers want to better understand why this happens and test a new method to improve it. They are testing two types of electrical stimulation applied to the outer ear: Cymba Conchae stimulation and Earlobe stimulation. The study will enroll 55 participants, aged 25 to 55, who are proficient in English. Some participants will have a history of TBI, while others will have normal hearing and no TBI. The main goal is to check if these stimulation methods are safe and practical to use, with this being assessed within 2 days to 2 weeks of starting treatment. The study's current status is unclear regarding recruitment.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 55 participants.
What's involved
The study involves electrical stimulation applied to the outer ear. The safety and feasibility of the treatment will be assessed between 2 days and 2 weeks from enrollment to the end of treatment.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07176936

Improving Speech in Noise Using Noninvasive Stimulation

Recruiting
NAAges 25–55InterventionalBasic science
University of Florida
~55 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Cymba Conchae stimulationEarlobe stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and feasibility
Measured over From enrollment to the end of treatment is between 2 days and 2 weeks.
Traumatic Brain Injury
Hearing Loss
1 sites across 1 states
Florida1

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Eligibility criteria

Inclusion

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

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).
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.
  • Safety and feasibilityFrom enrollment to the end of treatment is between 2 days and 2 weeks.

    quantify attrition as well as frequency and severity of adverse events