Improving Speech in Noise Using Noninvasive Stimulation

Not Applicable

Not yet recruiting

• Conditions: Traumatic Brain Injury; Hearing Loss

• Registration Number: NCT07176936
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-15
• Primary Completion: 2027-07-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Safety and feasibility	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 Outcome Measures

Name	Time	Method
Speech in Noise performance	Baseline and one week	Percent correct on a speech in noise perception task when receiving Treatment A compared to Treatment B
Brain response patterns	Baseline and one week	Pattern of brain response while listening to speech in background noise while receiving Treatment A compared to Treatment B

Trial Locations

Locations (1)

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States