PresbycusisNCT07192757
Improving Speech in Noise Perception for Individuals With Age-related Hearing Loss
A study testing transcutaneous auricular vagus nerve stimulation in people with Presbycusis, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbycusis
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 15 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 55-80 years old
- Normal hearing or age-related hearing loss (with or without hearing aids)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at the University of Florida
Gainesville, Florida, 32610
About this study
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
- Being tested
- transcutaneous auricular vagus nerve stimulation, Sham Control
- Keywords
- age-related hearing loss, taVNS, vagus nerve stimulation, presbycusis, hearing aids
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
active electrical stimulation applied to the cymba conchae of the left ear
Sham ControlDevice
electrical stimulation applied to a location on the ear not innervated by the auricular vagus
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | participants will receive low level electrical stimulation to the auricular branch of the vagus nerve during the sound in noise task Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Treatment B | Active comparator | Participants will receive stimulation to a control location Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech in noise performance
Percent correct on a speech in noise perception task in participants receiving Treatment A compared to Treatment B
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Dec 2025
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbycusisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192757
- Sponsor's protocol ID
- IRB202500769
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes