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Could a simple device ease stuffy ears and face pain without drugs?

NCT ID NCT04404036

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called SinuSonic that combines sound vibrations with gentle pressure to help people with Eustachian tube dysfunction (ETD) and facial pain. Thirty adults used the device twice a day for six weeks. Researchers measured changes in symptoms like ear pressure, clogging, and pain. The study was small and did not include a comparison group, so results are preliminary.

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
What this could lead to
If it works, this could offer a drug-free way to relieve ear pressure, clogging, and facial pain from Eustachian tube dysfunction.
What could go wrong
This was a small, early study with only 30 participants and no placebo group. Results may not apply to everyone, and the device may not work for all.

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

30 people

The number who actually took part.

Started

Apr 2020

Finished

Apr 2023

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

Accepted

You do not need to have the condition being studied to take part.

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.

AIM 1 Inclusion Criteria: * Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions Exclusion Criteria: * Sinonasal or ear surgery within last 3 months (including balloon ET dilation) * Any ENT condition that may impact upper airway to include sinusitis, otitis, or allergies * Upper respiratory illness within last 2 weeks * Topical decongestant use in last week * Current nasal crusting or ulceration on rhinoscopy * History of severe nose bleeding within last 3 months * Known pregnancy * Allergic sensitivity to silicone or any other component of device * Inability to read and understand English * Inability to perform treatment due to underlying medical condition AIM 2 Inclusion: * Adults 18 years or older with diagnosis of ETD by an otolaryngologist * ≥6 months of symptoms duration * ≥3 ETD symptoms (ear pressure, feeling that ears are clogged, cracking/popping of ears, muffled hearing, tinnitus) * ETDQ-7 score ≥ 3 * Audiogram within the last year Exclusion: * Sinonasal or ear surgery within last 3 months (including balloon ET dilation) * Indwelling ear tubes * Tympanic membrane perforation * Hx of cholesteatoma, mastoidectomy, tympanoplasty, or ossicular chain reconstruction * Patulous ET * Hx of Meniere's disease * Moderate or severe nasal valve collapse * Grade 3-4 polyps * Upper respiratory illness within last 2 weeks * Topical decongestant use in last week * Current nasal crusting or ulceration on rhinoscopy * History of severe nose bleeding within last 3 months * Known pregnancy * Allergic sensitivity to silicone or any other component of device * Inability to read and understand English * Inability to perform treatment due to underlying medical condition AIM 3 Inclusion: * Adults 18 years or older who complain of facial pain or pressure * ≥3 months of symptoms duration (can be intermittent) * Pain/pressure VAS score ≥ 5 Exclusion: * Sinonasal surgery within the last 3 months * Grade 3-4 polyps * Upper respiratory illness within last 2 weeks * Topical decongestant use in last week * Current nasal crusting or ulceration on rhinoscopy * History of severe nose bleeding within last 3 months * Known pregnancy * Allergic sensitivity to silicone or any other component of device * Inability to read and understand English * Inability to perform treatment due to underlying medical condition

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Sinus Center - Medical Univesity of South Carolina

    Charleston, South Carolina, 29425, United States

More trials for these conditions

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