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

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

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.

The original protocol included three planned cohorts:

• Aim 1 - healthy controls for exhaled nasal nitric oxide (NO) testing;
• Aim 2 - adults with Eustachian Tube Dysfunction (ETD) to evaluate safety and efficacy;
• Aim 3 - adults with facial pain/pressure.

Only Aim 2 (ETD cohort) was opened to enrollment. Aims 1 and 3 were not initiated, and no participants were enrolled in those cohorts.

During study conduct, several patient-reported outcome measures originally associated with Aim 3 (MPQ-SF and mBPI-sf) were also administered to the ETD cohort for exploratory symptom profiling. Therefore, the Results section includes ETD-specific measures (ETDQ-7, ETD Symptom VAS, tympanogram) as well as pain-related measures for participants enrolled in the ETD cohort. All analyses derive exclusively from the ETD cohort participants (N=29 with baseline data).

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