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

Completed · Not applicable

Conditions studied: Eustachian Tube Dysfunction, Facial Pain

In brief

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.

Key facts

Study ID

NCT04404036

Run by

Medical University of South Carolina

People needed

30

Starts

2020-04-28

Expected to finish

2023-04-25

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions

You may not qualify if…

• 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

Where it is running

• Sinus Center - Medical Univesity of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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