Eustachian Tube DysfunctionNCT04404036
SinuSonic for ETD and Facial Pain: Acoustic Vibration + Oscillating Expiratory Pressure
A study testing SinuSonic Device in people with Eustachian Tube Dysfunction and Facial Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eustachian Tube Dysfunction, Facial Pain
- What is being tested?
- SinuSonic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 38Show fewer
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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).
- Conditions
- Eustachian Tube Dysfunction, Facial Pain
- Being tested
- SinuSonic Device
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinuSonic DeviceDevice
A medical device that combines acoustic vibration with oscillating expiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| SinuSonic Device | Experimental | 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. Receives: Device: SinuSonic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score
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.
Measured: 6 weeks (baseline to 6-week follow-up)
Secondary outcomes (2)
McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score
The MPQ-SF includes 15 descriptors scored from 0 (none) to 3 (severe). Total score ranges from 0-45. Higher scores indicate worse pain.
Measured: 4 weeks
Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain
Participants rate worst pain on an 11-point scale from 0 = "No pain" to 10 = "Worst pain imaginable." Higher scores indicate worse pain.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start28 Apr 2020
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404036
- Sponsor's protocol ID
- PRO#00097842
- Status last verified
- Jan 2026
- First submitted
- 21 May 2020
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not Applicable. The investigators plan to publish this study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
- ClinicalTrials.gov ID
- NCT04404036
- Acronym / sponsor ID
- PRO#00097842
- Conditions
- Eustachian Tube Dysfunction, Facial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SinuSonic Device | Experimental | Device: SinuSonic DeviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SinuSonic DeviceA medical device that combines acoustic vibration with oscillating expiratory pressure. | Device | SinuSonic Device |
Primary outcome
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.
2 secondary outcomes
McGill Pain Questionnaire - Short Form (MPQ-SF) Total Score
Time frame: 4 weeks
Modified Brief Pain Inventory - Short Form (mBPI-sf): Worst Pain
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not Applicable. The investigators plan to publish this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SinuSonic Device in people with Eustachian Tube Dysfunction and Facial Pain, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eustachian Tube Dysfunction (ETD) Symptom Visual Analog Scale (VAS) - Total Score (time frame: 6 weeks (baseline to 6-week follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.