Facial PainNCT05479604
Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure
A study testing SinuSonic in people with Facial Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Pain
- What is being tested?
- SinuSonic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 7 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be > 18 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Facial pain or pressure for > 3 months of symptom duration.
- Pain/pressure VAS (Visual Analogue Scale) Score of > 5.
Who cannot join
- Upper respiratory illness within the last 2 weeks.
- History of severe epistaxis.
- Known pregnancy.
- Allergic sensitivity to silicone or any other component of device.
- Sinonasal surgery in the last 3 months.
- Topical decongestant use in the last week.
Show all 10Show fewer
- Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.
- Sinusitis on imaging.
- Nasal crusting or ulceration on exam.
- Inability to read or understand English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure: Randomized Controlled Trial
The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.
- Conditions
- Facial Pain
- Being tested
- SinuSonic, Sham Device
- Keywords
- Facial Pressure
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinuSonicDevice
Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.
Sham DeviceDevice
Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
| Study group | Role | What they receive |
|---|---|---|
| SinuSonic Group | Experimental | Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks Receives: Device: SinuSonic |
| Sham Group | Sham comparator | Subjects will use the sham device for 2 minutes twice daily for 8 weeks Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Facial Pain Visual Analogue Scale (VAS)
Participants rated sinus or facial pain/pressure using a 0-10 Visual Analogue Scale (VAS) which measured the average sinus pain over the past week. The VAS was displayed as a horizontal sliding scale on an electronic survey, where participants moved a slider along a continuum from 0 = no pain to 10 = worst possible pain. The slider allowed for selection of whole-number values only. Higher scores indicate worse outcomes (greater pain); lower scores indicate better outcomes (less pain).
Measured: Baseline, 8 weeks
Change in Brief Pain Inventory Short Form (BPI-SF)
The Brief Pain Inventory - Short Form (BPI-SF) is a 9-item self-report questionnaire that assesses pain severity and its impact on daily functioning. Pain intensity (worst, least, average, current) and pain interference (e.g., activity, mood, sleep) are rated on a 0-10 scale, with 0 = no pain/no interference and 10 = worst pain/completely interferes. Higher scores indicate worse outcomes, whereas lower scores indicate better outcomes.
Measured: Baseline, 8 weeks
Secondary outcomes (3)
Subjects Reporting Pain With Device Use
Number of subjects reporting pain with device use
Measured: 8 weeks
Subjects Reporting Epistaxis
Number of subjects reporting epistaxis
Measured: 8 weeks
Change in Nasal Obstruction Symptoms
The Nasal Obstruction Symptom Evaluation (NOSE) Score is a 5-item, self-reported survey that assesses the impact of nasal obstruction on quality of life over the past month; each item is rated from 0 (not a problem) to 4 (severe problem). These five items form a single subscale (i.e., nasal obstruction symptom severity). The responses to all 5 items are summed to yield a raw total score ranging from 0 to 20. Raw scores are scaled to a total score out of 100, by multiplying by 5. Nasal Obstruction Severity Classification categories: Mild (5-25), Moderate (30-50), Severe (55-75), Extreme (80-100). A score of 0 means that there are no problems with nasal obstruction and a score of 100 means that they are experiencing the worst possible problems with nasal obstruction. NOSE scores will be obtained at 'Baseline' and 'Week 8,' to measure obstruction changes with device use (sham vs real).
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start22 Mar 2023
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Why it stopped: participant non-compliance
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 Facial PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amar Miglani, Mayo Clinic
- Investigators
- Amar Miglani, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479604
- Sponsor's protocol ID
- 22-001904
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2022
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05479604
- Acronym / sponsor ID
- 22-001904
- Conditions
- Facial Pain
- Keywords
- Facial Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: participant non-compliance
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Posted 10 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SinuSonic Group | Experimental | Device: SinuSonicSubjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks |
| Sham Group | Sham comparator | Device: Sham DeviceSubjects will use the sham device for 2 minutes twice daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be > 18 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Facial pain or pressure for > 3 months of symptom duration.
- Pain/pressure VAS (Visual Analogue Scale) Score of > 5.
Key exclusion criteria (10 listed)
- Upper respiratory illness within the last 2 weeks.
- History of severe epistaxis.
- Known pregnancy.
- Allergic sensitivity to silicone or any other component of device.
- Sinonasal surgery in the last 3 months.
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 |
|---|---|---|
| SinuSonicHandheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming. | Device | SinuSonic Group |
| Sham DeviceDevice looks exactly like study device but does not emit the same pressure or make the same noise as the study device | Device | Sham Group |
Primary outcome
Change in Facial Pain Visual Analogue Scale (VAS)
Time frame: Baseline, 8 weeks
Participants rated sinus or facial pain/pressure using a 0-10 Visual Analogue Scale (VAS) which measured the average sinus pain over the past week. The VAS was displayed as a horizontal sliding scale on an electronic survey, where participants moved a slider along a continuum from 0 = no pain to 10 = worst possible pain. The slider allowed for selection of whole-number values only. Higher scores indicate worse outcomes (greater pain); lower scores indicate better outcomes (less pain).
Change in Brief Pain Inventory Short Form (BPI-SF)
Time frame: Baseline, 8 weeks
The Brief Pain Inventory - Short Form (BPI-SF) is a 9-item self-report questionnaire that assesses pain severity and its impact on daily functioning. Pain intensity (worst, least, average, current) and pain interference (e.g., activity, mood, sleep) are rated on a 0-10 scale, with 0 = no pain/no interference and 10 = worst pain/completely interferes. Higher scores indicate worse outcomes, whereas lower scores indicate better outcomes.
3 secondary outcomes
Subjects Reporting Pain With Device Use
Time frame: 8 weeks
Subjects Reporting Epistaxis
Time frame: 8 weeks
Change in Nasal Obstruction Symptoms
Time frame: Baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Amar Miglani, M.D. principal investigator
Mayo Clinic
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 in people with Facial Pain, run by Mayo Clinic 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Sep 2025. 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. Some participants in this study may receive a placebo. 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 10 Sep 2025). 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?
Change in Facial Pain Visual Analogue Scale (VAS) (time frame: Baseline, 8 weeks). The study lists 2 primary outcomes in all. 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 10 Sep 2025.