CompletedNot Applicable

SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure

United States30 participantsStarted 2020-04-28

Plain-language summary

This study was originally designed with three aims: (1) healthy controls to assess nasal nitric oxide, (2) adults with Eustachian Tube Dysfunction (ETD), and (3) adults with facial pain/pressure. However, only the ETD cohort (Aim 2) was initiated and enrolled. During study conduct, additional symptom and pain assessments (including MPQ-SF and mBPI-sf) were collected in the ETD cohort for exploratory purposes. All results in this record reflect ETD cohort participants who used the SinuSonic device twice daily for 6 weeks.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score

Timeframe: 6 weeks (baseline to 6-week follow-up)

Trial details

NCT IDNCT04404036

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-25

Results submitted2024-09-30

View on ClinicalTrials.gov More Eustachian Tube Dysfunction trials