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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Speech in Noise Perception for Individuals With Age-related Hearing Loss
- ClinicalTrials.gov ID
- NCT07192757
- Acronym / sponsor ID
- IRB202500769
- Conditions
- Presbycusis
- Keywords
- age-related hearing loss, taVNS, vagus nerve stimulation, presbycusis, hearing aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Device: transcutaneous auricular vagus nerve stimulationparticipants will receive low level electrical stimulation to the auricular branch of the vagus nerve during the sound in noise task |
| Treatment B | Active comparator | Device: Sham ControlParticipants will receive stimulation to a control location |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 55-80 years old
- Normal hearing or age-related hearing loss (with or without hearing aids)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular vagus nerve stimulationactive electrical stimulation applied to the cymba conchae of the left ear | Device | Treatment A |
| Sham Controlelectrical stimulation applied to a location on the ear not innervated by the auricular vagus | Device | Treatment B |
Primary outcome
Speech in noise performance
Time frame: 2 weeks
Percent correct on a speech in noise perception task in participants receiving Treatment A compared to Treatment B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagus nerve stimulation in people with Presbycusis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech in noise performance (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.