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Ear zap may calm bleeding and nausea in sinus surgery

NCT ID NCT06662422

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study tests whether a small device worn on the ear, which gently stimulates a nerve linked to the body's calming system, can improve conditions during sinus surgery. Half of the participants will receive the active stimulation, while the other half gets a sham device. Researchers will measure bleeding during the operation and check for nausea or vomiting after surgery to see if the stimulation helps.

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 neurostimulation (tAN) via the Spark Biomedical Sparrow Ascent system, a wearable electrode placed on the ear
What this could lead to
If effective, this non-invasive ear stimulation could become a simple way to reduce bleeding during sinus surgery and ease post-operative nausea.
What could go wrong
This is a small, early-stage trial with only 20 participants, so results may not be conclusive. The device may not improve outcomes, and individual responses can vary.

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

20 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2025

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 years and older

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: * ASA 1 and 2 * Presenting for elective FESS surgery Exclusion Criteria: * Anti-fibrinolytic use within 30 days of enrollment * Known or acquired coagulation disorders * Hypercoagulable state, including morbid obesity and active smoking * Pregnancy * Blood transfusion with 30 days of enrollment * History of epileptic seizures * Presence of device such as pacemaker, cochlear prosthesis, neurostimulator * Ear infection * Abnormal ear anatomy which inhibits application of device * Presence of other significant disease or disorder which under the discretion of the principal investigator could influence the results of the trial or the participant's ability to participate in the trial

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Conditions

The condition(s) this trial relates to.

Hemorrhage Pain, Postoperative

As listed by the trial registrant

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

Functional endoscopic sinus surgery Platelet activation Vagal nerve stimulation

Contacts and locations

Locations

  • Mount Sinai Hospital

    New York, New York, 10029, United States

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