Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07176936

Improving Speech in Noise Using Noninvasive Stimulation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cymba Conchae stimulation

Device

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

Other names: Treatment A

Earlobe stimulation

Device

Electrical stimulation applied to the earlobe region of the outer ear

Other names: Treatment B

Primary outcomes

  1. 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

Secondary outcomes

  1. Speech in Noise performance

    Time frame: Baseline and one week

    Percent correct on a speech in noise perception task when receiving Treatment A compared to Treatment B

  2. Brain response patterns

    Time frame: Baseline and one week

    Pattern of brain response while listening to speech in background noise while receiving Treatment A compared to Treatment B

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.