Clinical trial NCT04404036: Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
Official title: Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eustachian Tube Dysfunction
Facial Pain
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Symptoms severity according to an ETD Visual Analogue Scale
timeFrame: 6 Weeks
measure: Symptoms severity according to a Pain/pressure Visual Analogue Scale
timeFrame: 2 to 4 Weeks
Secondary outcomes:
measure: McGill Pain Questionnaire - Short Form
timeFrame: 2 to 4 Weeks
measure: Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
timeFrame: 2 to 4 Weeks
measure: Mean Change in Overall ETDQ-7 Score
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Sinus Center - Medical Univesity of South Carolina
state: South Carolina
Study officials:
References: