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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Facial Pain; Eustachian Tube Dysfunction

Treatments: Device: SinuSonic Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04404036

PRO#00097842

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

SinuSonic Device

Experimental group

Description:

Aim 1: SinuSonic device used once a day over a 2 day period. Aim 2: SinuSonic device used twice daily for 3 minutes in the home setting for 6 weeks. Aim 3: SinuSonic device used twice daily for 3 minutes in the home setting for 4 weeks.

Treatment:

Device: SinuSonic Device