Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
Keywords
Abstract
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 05/20/2020 |
| Estimated Enrollment Submitted: | 05/20/2020 |
| First Posted: | 05/26/2020 |
| Last Update Submitted: | 07/15/2020 |
| Last Update Posted: | 07/16/2020 |
| Actual Study Start Date: | 07/31/2020 |
| Estimated Primary Completion Date: | 12/30/2020 |
| Estimated Study Completion Date: | 04/30/2021 |
Condition or disease
Intervention/treatment
Device: SinuSonic Device
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: SinuSonic Device Aim 1: SinuSonic device used once a day over a 2 day period.
Aim 2: SinuSonic device used twice daily for 3 minutes in the home setting for 6 weeks.
Aim 3: SinuSonic device used twice daily for 3 minutes in the home setting for 4 weeks. | Device: SinuSonic Device A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Symptoms severity according to an ETD Visual Analogue Scale [6 Weeks]
2. Symptoms severity according to a Pain/pressure Visual Analogue Scale [2 to 4 Weeks]
Secondary Outcome Measures
1. McGill Pain Questionnaire - Short Form [2 to 4 Weeks]
2. Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) [2 to 4 Weeks]
3. Mean Change in Overall ETDQ-7 Score [6 Weeks]
