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Ear zap may boost blood flow in leg artery disease

NCT ID NCT03445754

Symptom relief Sponsor: University of Oklahoma Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested if a gentle electrical stimulation on the ear (transcutaneous vagal stimulation) could improve blood vessel function in 11 people with peripheral artery disease (PAD). The goal was to see if this non-invasive method could help blood vessels relax and work better. The approach is experimental and early-stage, focusing on short-term effects.

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

11 people

The number who actually took part.

Started

Dec 2017

Finished

May 2020

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

18 to 85 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: 1. peripheral arterial disease (PAD) - patients with an ankle-brachial index of \<0.9 2. symptoms of intermittent claudication, rest pain, or minor tissue loss (Rutherford category I-V) Exclusion Criteria: 1. patients with acute limb ischemia 2. Patients with overt congestive heart failure / recent acute myocardial infarction (\< 3 months) 3. Premenopausal women and post-menopausal women on hormone supplements. 4. chronic inflammatory disease (systemic lupus erythematosus, rheumatoid arthritis, and Crohn's disease), or receiving therapy with steroids, cyclosporine, methotrexate or immunocompromised patients. 5. unilateral or bilateral vagotomy 6. Patients with bilateral upper extremity amputation 7. pregnant patients 8. prisoners 9. end-stage renal disease. 10. End-stage liver disease. 11. patients with BMI\>34 12. Patients with upper extremity arterial disease 13. history of recurrent vasovagal syncope, Sick sinus syndrome, 2nd- or 3rd-degree atrioventricular block (AV) block, prolonged first degree AV block. 14. Refusal to sign a consent form. 15. Significant hypotension from autonomic dysfunction 16. Patients with pacemakers who have significant interaction with TVNS during testing

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

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

Autonomic imbalance Endothelial dysfunction Peripheral artery disease

Contacts and locations

Locations

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73117, United States

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Other studies related to the condition(s) this trial covers.