Health TrialsbyHealthPanel

Improving Speech in Noise Using Noninvasive Stimulation

ConditionsTraumatic Brain InjuryHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-55
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cymba Conchae stimulation

    Device

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

  • Earlobe stimulation

    Device

    Electrical stimulation applied to the earlobe region of the outer ear

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Treatment A vs Treatment BOther 2 interventions
Group B: Treatment B then Treatment AOther 2 interventions

Trial outcomes

Primary outcomes

1

Safety and feasibility

quantify attrition as well as frequency and severity of adverse events

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

Secondary outcomes

1

Speech in Noise performance

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

Time frame
Baseline and one week
2

Brain response patterns

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

Time frame
Baseline and one week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
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