SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure

January 27, 2026 updated by: Medical University of South Carolina

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

This study was originally designed with three aims: (1) healthy controls to assess nasal nitric oxide, (2) adults with Eustachian Tube Dysfunction (ETD), and (3) adults with facial pain/pressure. However, only the ETD cohort (Aim 2) was initiated and enrolled. During study conduct, additional symptom and pain assessments (including MPQ-SF and mBPI-sf) were collected in the ETD cohort for exploratory purposes. All results in this record reflect ETD cohort participants who used the SinuSonic device twice daily for 6 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The original protocol included three planned cohorts:

  • Aim 1 - healthy controls for exhaled nasal nitric oxide (NO) testing;
  • Aim 2 - adults with Eustachian Tube Dysfunction (ETD) to evaluate safety and efficacy;
  • Aim 3 - adults with facial pain/pressure.

Only Aim 2 (ETD cohort) was opened to enrollment. Aims 1 and 3 were not initiated, and no participants were enrolled in those cohorts.

During study conduct, several patient-reported outcome measures originally associated with Aim 3 (MPQ-SF and mBPI-sf) were also administered to the ETD cohort for exploratory symptom profiling. Therefore, the Results section includes ETD-specific measures (ETDQ-7, ETD Symptom VAS, tympanogram) as well as pain-related measures for participants enrolled in the ETD cohort. All analyses derive exclusively from the ETD cohort participants (N=29 with baseline data).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Sinus Center - Medical Univesity of South Carolina

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SinuSonic Device
Participants used the SinuSonic device twice daily for 3 minutes in the home setting for 6 weeks. Baseline and 6-week assessments included ETDQ-7, ETD Symptom VAS, and tympanogram. Additional symptom and pain measures (MPQ-SF, mBPI-sf) were collected for exploratory purposes in this cohort.
Device: SinuSonic Device
A medical device that combines acoustic vibration with oscillating expiratory pressure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score
Time Frame: 6 weeks (baseline to 6-week follow-up)
Five ETD symptoms (ear pressure, ear clogging, cracking/popping, muffled hearing, tinnitus) are each rated on a 10-cm line from 0 = "Not troublesome" to 10 = "Worst thinkable/troublesome." The total score is the sum of all five items (range 0-60). Higher scores indicate worse symptoms.
6 weeks (baseline to 6-week follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score
Time Frame: 4 weeks
The MPQ-SF includes 15 descriptors scored from 0 (none) to 3 (severe). Total score ranges from 0-45. Higher scores indicate worse pain.
4 weeks
Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain
Time Frame: 4 weeks
Participants rate worst pain on an 11-point scale from 0 = "No pain" to 10 = "Worst pain imaginable." Higher scores indicate worse pain.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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