NCT07176936

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Aug 2027

First Submitted

Initial submission to the registry

September 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

March 21, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

September 9, 2025

Last Update Submit

March 26, 2026

Conditions

Traumatic Brain InjuryHearing Loss

Outcome Measures

Primary Outcomes (1)

  • Safety and feasibility

    quantify attrition as well as frequency and severity of adverse events

    From enrollment to the end of treatment is between 2 days and 2 weeks.

Secondary Outcomes (2)

  • Speech in Noise performance

    Baseline and one week

  • Brain response patterns

    Baseline and one week

Study Arms (2)

Treatment A vs Treatment B

OTHER

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

Device: Cymba Conchae stimulationDevice: Earlobe stimulation

Treatment B then Treatment A

OTHER

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

Device: Cymba Conchae stimulationDevice: Earlobe stimulation

Interventions

Cymba Conchae stimulationDEVICE

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

Also known as: Treatment A
Treatment A vs Treatment BTreatment B then Treatment A
Earlobe stimulationDEVICE

Electrical stimulation applied to the earlobe region of the outer ear

Also known as: Treatment B
Treatment A vs Treatment BTreatment B then Treatment A

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticHearing Loss

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 16, 2025

Study Start

March 21, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified data will be shared at the time of data publication

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be shared at the time of publication and will be available indefinitely
Access Criteria
Data and protocols will be shared openly.

Locations

US(1)