- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404036
Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
July 31, 2023 updated by: Shaun A. Nguyen, MD, Medical University of South Carolina
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 device that utilizes sound and pressure combined with normal breathing.
The study will have 3 aims.
Aim 1 will examine healthy controls with no signs of upper respiratory infection, inflammation, or ETD to determine if exhaled nasal Nitric Oxide is increased.
Nitric Oxide is a compound in the body that acts as a blood vessel relaxant.
Acoustic energy (humming) has been shown to increase nasal Nitric Oxide dramatically, thus equalization of gas pressures between the middle ear, the paranasal sinuses and the nasal cavity may very well explain any efficacy noted.
Aim 2 will be performed to examine therapeutic efficacy for ETD.
Aim 3 will be performed to examine therapeutic efficacy for sinus pain/pressure.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Matthew Germroth
- Phone Number: 8438761166
- Email: germroth@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Sinus Center - Medical Univesity of South Carolina
-
Contact:
- Thomas C Lackland
-
Principal Investigator:
- Theodore McRackan, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms severity according to an ETD Visual Analogue Scale
Time Frame: 6 Weeks
|
Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10).
Visual Analogue Scale is a psychometric response scale which can be used in questionnaires.
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
|
6 Weeks
|
Symptoms severity according to a Pain/pressure Visual Analogue Scale
Time Frame: 2 to 4 Weeks
|
Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10).
Visual Analogue Scale is a psychometric response scale which can be used in questionnaires.
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
|
2 to 4 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
McGill Pain Questionnaire - Short Form
Time Frame: 2 to 4 Weeks
|
The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score.
The scale ranges from 0-10 (0=no pain, 10=the most pain).
|
2 to 4 Weeks
|
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
Time Frame: 2 to 4 Weeks
|
Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).
|
2 to 4 Weeks
|
Mean Change in Overall ETDQ-7 Score
Time Frame: 6 Weeks
|
Mean change from baseline to 6 weeks in the overall ETDQ-7 score.
The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity.
The 7 items are: pressure in the ears, pain in the ears, a feeling that the participant's ears are clogged or underwater, ear symptoms when the participants have a cold or sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that the participant's hearing is muffled.
Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7).
Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 2020
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
May 21, 2020
First Submitted That Met QC Criteria
May 21, 2020
First Posted (Actual)
May 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO#00097842
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not Applicable.
The investigators plan to publish this study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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