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Ear nerve zap may ease stiff heart condition

NCT ID NCT03327649

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

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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 Results may not be published yet.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
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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This status has not been confirmed recently, so it may be out of date.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 a gentle electrical stimulation of a nerve in the ear (called tVNS) to see if it could reduce inflammation and improve heart function and exercise ability in people with a type of heart failure called HFpEF. 52 adults with HFpEF received either the real stimulation or a fake (sham) device for one hour daily over three months. The goal was to see if this safe, non-invasive approach could offer a new way to help patients who have few treatment options.

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

52 people

The number who actually took part.

Started

Dec 2017

Finished

Sep 2021

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

21 to 90 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: * HFpEF, defined as signs and symptoms of heart failure, LV ejection fraction ≥50%, brain natriuretic peptide ≥35pg/mL and echocardiographic evidence of diastolic dysfunction (left atrial volume index ≥34mL/m2, mitral E-wave velocity/mitral annular velocity ratio \[E/e'\]≥13 and e'\<9cm/s) plus 2 of the following 4 comorbidities: * age ≥ 65, * diabetes, * hypertension and * obesity, defined as body mass index ≥30kg/m2 Exclusion Criteria: * LV ejection fraction \<40% * significant valvular disorder (i.e., prosthetic valve or hemodynamically significant valvular diseases) * recent (\<6 months) stroke, myocardial infarction or hospitalization for heart failure * severe heart failure (class III or IV) * end stage kidney disease * recurrent vasovagal syncope * history of vagotomy * pregnancy * sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker).

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Conditions

The condition(s) this trial relates to.

diastolic heart failure Inflammation

As listed by the trial registrant

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

Heart failure with normal ejection fraction

Contacts and locations

Locations

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

More trials for these conditions

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