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Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure

Primary Purpose

Eustachian Tube Dysfunction, Facial Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SinuSonic Device
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eustachian Tube Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sinus Center - Medical Univesity of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SinuSonic Device

Arm Description

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.

Outcomes

Primary Outcome Measures

Symptoms severity according to an ETD Visual Analogue Scale
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.
Symptoms severity according to a Pain/pressure Visual Analogue Scale
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.

Secondary Outcome Measures

McGill Pain Questionnaire - Short Form
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).
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
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).
Mean Change in Overall ETDQ-7 Score
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.

Full Information

First Posted
May 21, 2020
Last Updated
July 31, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04404036
Brief Title
Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
Official Title
Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eustachian Tube Dysfunction, Facial Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SinuSonic Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SinuSonic Device
Intervention Description
A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
Primary Outcome Measure Information:
Title
Symptoms severity according to an ETD Visual Analogue Scale
Description
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.
Time Frame
6 Weeks
Title
Symptoms severity according to a Pain/pressure Visual Analogue Scale
Description
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.
Time Frame
2 to 4 Weeks
Secondary Outcome Measure Information:
Title
McGill Pain Questionnaire - Short Form
Description
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).
Time Frame
2 to 4 Weeks
Title
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
Description
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).
Time Frame
2 to 4 Weeks
Title
Mean Change in Overall ETDQ-7 Score
Description
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.
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Germroth
Phone
8438761166
Email
germroth@musc.edu
Facility Information:
Facility Name
Sinus Center - Medical Univesity of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas C Lackland
First Name & Middle Initial & Last Name & Degree
Theodore McRackan, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not Applicable. The investigators plan to publish this study.

Learn more about this trial

Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure

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