Could a simple device ease stuffy ears and face pain without drugs?
NCT ID NCT04404036
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
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30 people
The number who actually took part.
- Started
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Apr 2020
- Finished
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Apr 2023
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, 29425, United States
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Other studies related to the condition(s) this trial covers.
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