Phase
Condition
Otitis Media
Ear Infections
Ear Infections (Pediatric)
Treatment
SinuSonic Device
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
AIM 1
Inclusion Criteria:
- Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions
Exclusion
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, orallergies
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 ofears, 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
Study Design
Connect with a study center
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
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