Improving Speech in Noise Using Noninvasive Stimulation

NCT ID: NCT07176936

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Cymba Conchae stimulation

Intervention Type: DEVICE

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

Earlobe stimulation

Intervention Type: DEVICE

Electrical stimulation applied to the earlobe region of the outer ear

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.

Group Type: OTHER

Cymba Conchae stimulation

Intervention Type: DEVICE

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

Earlobe stimulation

Intervention Type: DEVICE

Electrical stimulation applied to the earlobe region of the outer ear

Interventions

Cymba Conchae stimulation

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

Intervention Type: DEVICE

Earlobe stimulation

Electrical stimulation applied to the earlobe region of the outer ear

Intervention Type: DEVICE

Other Intervention Names

Treatment A; Treatment B

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UF Health at the University of Florida

Gainesville, Florida, United States

Countries

United States

Facility Contacts

Tracy Centanni, Ph.D.

Role: primary

tracy.centanni@phhp.ufl.edu

352-294-8675

John Williamson, Ph.D.

Role: backup

john.williamson@ufl.edu

Other Identifiers

RH240016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB202500139

Identifier Type: -

Identifier Source: org_study_id