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Ear zap might help stroke patients breathe easier

NCT ID NCT06793800

Symptom relief Sponsor: Fenerbahce University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a non-invasive device that gently stimulates a nerve in the ear can improve breathing muscle strength in people who had a stroke 1-3 years ago. Researchers will measure lung function in 50 participants before and after treatment. If successful, TAVNS could become a simple add-on to standard rehabilitation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) device
What this could lead to
If it works, this could offer a simple, non-invasive way to help stroke survivors breathe easier and improve their rehabilitation.
What could go wrong
This is a small, early-stage trial with only 50 people, so results may not apply to everyone. The device may not improve breathing significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Being a chronic stroke patient with an ischemic or hemorrhagic stroke diagnosis made 1-3 years ago * Having been diagnosed with stroke for the first time * Ability to understand and follow simple verbal instructions * Being between the ages of 40 and 80 * No conditions affecting perioral muscles, such as facial paralysis or swallowing disorders * No visual, auditory, or communication problems * No cardiopulmonary disorders * No additional neurological, cardiovascular, orthopedic, or similar conditions causing balance problems * Mini Mental State Examination (MMSE) score ≥24 * No surgical operations or Botox applications in the last 6 months * Scoring 2 or below on the Modified Ashworth Scale Exclusion Criteria: * Presence of infection, ulcer, or scar on the auricle * Metallic implants in the skull, hypersensitivity, injury, or inflammation inside the ear * Chronic pulmonary and/or cardiac diseases * Resting heart rate below 60 beats per minute * Devices such as pacemakers or cochlear implants * Uncontrolled hypertension * Chronic obstructive pulmonary disease (COPD) or asthma unrelated to stroke * History of surgical operation or Botox application within the last 6 months * Presence of aphasia, apraxia, or neglect syndrome * History of 2 or more strokes (SVO) * Comorbid conditions affecting respiratory functions (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, contractures, deformities after fractures, active upper or lower respiratory infections, etc.) * Lack of cooperation

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Conditions

The condition(s) this trial relates to.

hemiplegia Respiratory Aspiration stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemiplegia Respiratory function loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mediworld Medical Center Physical Therapy and Rehabilitation Department

    RECRUITING

    Istanbul, 34040, Turkey (Türkiye)

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