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New device uses humming vibrations to zap sinus pain

NCT ID NCT05479604

Symptom relief Sponsor: Mayo Clinic 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a device called SinuSonic that uses sound vibrations and pressure to relieve sinus headache pain. The trial included 27 adults with facial pain lasting more than 3 months. Participants used either the real device or a sham device that looked the same but didn't work. The study was stopped early, so it's unclear if the device truly helps.

What this could mean

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

Active substance
SinuSonic device (handheld device using acoustic vibration and oscillating expiratory pressure)
What this could lead to
If it works, this could offer a drug-free option for people with sinus headaches to reduce facial pain and pressure.
What could go wrong
The trial was terminated early and had only 27 participants, so results are limited. The device may not work better than a sham device.

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

27 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 2024

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: * Participant must be \> 18 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Facial pain or pressure for \> 3 months of symptom duration. * Pain/pressure VAS (Visual Analogue Scale) Score of \> 5. Exclusion Criteria: * Upper respiratory illness within the last 2 weeks. * History of severe epistaxis. * Known pregnancy. * Allergic sensitivity to silicone or any other component of device. * Sinonasal surgery in the last 3 months. * Topical decongestant use in the last week. * Nasal polyposis, purulence/edema, or other signs of sinusitis on exam. * Sinusitis on imaging. * Nasal crusting or ulceration on exam. * Inability to read or understand English.

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Conditions

The condition(s) this trial relates to.

facial neuralgia Facial Pain

As listed by the trial registrant

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

Facial pain

Contacts and locations

Locations

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

More trials for these conditions

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