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Behavioural Intervention

SinuSonic Device for Eustachian Tube Dysfunction and Facial Pain

N/A

Waitlist Available

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the SinuSonic device, which uses sound and gentle pressure with normal breathing. It targets adults with eustachian tube dysfunction or facial pain/pressure. The device may help by increasing Nitric Oxide in the nose, which relaxes blood vessels and balances air pressure in the ear and sinuses.

Who is the study for?

This trial is for adults over 18 with facial pain or pressure for at least 3 months, or diagnosed Eustachian Tube Dysfunction (ETD) by an ENT specialist, with symptoms like ear pressure and muffled hearing. It's not for those who've had recent ear surgery, have certain ear conditions, severe nasal issues, a cold in the last two weeks, used nasal decongestants recently, are pregnant or can't understand English.

What is being tested?

The SinuSonic device is being tested to see if it helps adults with ETD or facial pain. The device combines sound and breathing techniques to potentially increase Nitric Oxide in the nose which might help balance gas pressures in the ears and sinuses.

What are the potential side effects?

Since this study involves a non-invasive device that uses acoustic vibration and oscillating expiratory pressure through normal breathing techniques, side effects may be minimal but could include discomfort from using the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and do not have symptoms of upper respiratory or ear, nose, throat conditions.

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I am an adult with facial pain or pressure for 3 months or more, and my pain level is at least 5 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Criterion: You had surgery in the nose or ear within the last 3 months, have certain ear conditions, severe nasal issues, or other medical conditions, or are pregnant or allergic to certain materials.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Symptoms severity according to a Pain/pressure Visual Analogue Scale

Symptoms severity according to an ETD Visual Analogue Scale

Secondary study objectives

McGill Pain Questionnaire - Short Form

Mean Change in Overall ETDQ-7 Score

Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SinuSonic DeviceExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SinuSonic Device

2019

N/A

~210

0 / 3Eligibility criteria met