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

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

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

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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