Status:
COMPLETED
Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
Lead Sponsor:
Medical University of South Carolina
Conditions:
Eustachian Tube Dysfunction
Facial Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- AIM 1
- Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04404036
Start Date
April 28 2020
End Date
April 25 2023
Last Update
September 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, United States, 29425