Improving Speech in Noise Perception for Individuals With Age-related Hearing Loss

NCT07192757 | Recruiting FDA Device

• 1 other identifier: IRB202500769
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Hearing loss, especially for speech perception in the presence of noise, may lead older individuals to withdraw from social situations. While hearing aids help amplify sound and are useful in many situations, they can be ineffective in noisy contexts. The proposed pilot study will evaluate taVNS for improving speech in noise perception in adults with age-related hearing loss.

Conditions

Presbycusis

Keywords

age-related hearing loss; taVNS; vagus nerve stimulation; presbycusis; hearing aids

Outcome Measures

Primary Outcomes (1)

• Speech in noise performance

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

  2 weeks

Other Outcomes (2)

• Predictive value of audiometric testing

  2 weeks

• Predictive value of brain measures

  2 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

participants will receive low level electrical stimulation to the auricular branch of the vagus nerve during the sound in noise task

Device: transcutaneous auricular vagus nerve stimulation

Treatment B

ACTIVE COMPARATOR

Participants will receive stimulation to a control location

Device: Sham Control

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

active electrical stimulation applied to the cymba conchae of the left ear

Treatment A

Sham Control DEVICE

electrical stimulation applied to a location on the ear not innervated by the auricular vagus

Treatment B

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 55-80 years old
• Normal hearing or age-related hearing loss (with or without hearing aids)

You may not qualify if:

• History of traumatic brain injury or noise trauma
• Implanted medical devices (eg., pacemaker) or ferrous metal
• Known history of heart conditions
• Medications that impact neurotransmitters released by vagus nerve stimulation

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Presbycusis

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tracy Centanni, PhD

CONTACT

3522948675; tracy.centanni@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-08

Locations

US (1)