Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure

STATUS

Recruiting
End date

Jul 1, 2025
participants needed

70
sponsor

Medical University of South Carolina

Updated on 4 October 2022

See if I qualify

a compound

upper respiratory infection

Accepts healthy volunteers

Summary

This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with eustachian tube dysfunction (ETD) or facial pain/pressure. SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 3 aims. Aim 1 will examine healthy controls with no signs of upper respiratory infection, inflammation, or ETD to determine if exhaled nasal Nitric Oxide is increased. Nitric Oxide is a compound in the body that acts as a blood vessel relaxant. Acoustic energy (humming) has been shown to increase nasal Nitric Oxide dramatically, thus equalization of gas pressures between the middle ear, the paranasal sinuses and the nasal cavity may very well explain any efficacy noted. Aim 2 will be performed to examine therapeutic efficacy for ETD. Aim 3 will be performed to examine therapeutic efficacy for sinus pain/pressure.

Details

Condition	Eustachian Tube Dysfunction, Facial Pain
Treatment	SinuSonic Device
Clinical Study Identifier	NCT04404036
Sponsor	Medical University of South Carolina
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
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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Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure