SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure (NCT04404036) | Clinical Trial Compass
CompletedNot Applicable
SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure
United States30 participantsStarted 2020-04-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score