SinuSonic for Sinus Headache

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Topical decongestants

Disqualifiers: Upper respiratory illness, Pregnancy, Sinonasal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the SinuSonic device can reduce facial pain and pressure from sinus headaches. Participants will use either the SinuSonic device or a sham (fake) device for two minutes, twice a day, over eight weeks. The trial targets individuals who have experienced intense facial pain or pressure for more than three months.

As an unphased trial, participants can contribute to innovative research that may lead to new solutions for sinus headaches.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you should not have used topical decongestants in the last week before joining the trial.

What prior data suggests that the SinuSonic device is safe for sinus headache relief?

Research has shown that the SinuSonic device is safe for use. Previous studies found that the device did not cause discomfort. In one study, participants reported no negative side effects, indicating no problems occurred. Another study found the device safe and effective for reducing nasal congestion, making it easy to use. Overall, past research supports the SinuSonic device's strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SinuSonic device is unique because it offers a new way to tackle sinus headaches using acoustic vibrations and gentle pressure. Unlike standard treatments like decongestants or antihistamines, which often focus on reducing inflammation or blocking histamines, SinuSonic targets the sinus passages directly with a simple, non-invasive device. Researchers are excited about its potential because it could provide relief without the use of medication, reducing the risk of side effects and making it an attractive option for those seeking a more natural approach to managing sinus headaches.

What evidence suggests that the SinuSonic device is effective for sinus headache?

Research shows that the SinuSonic device, available to participants in this trial, may help reduce stuffy noses, often linked to sinus headaches. A previous study found that people felt much better and experienced noticeable improvements after using SinuSonic. Participants reported moderate to large benefits without discomfort. The device uses sound waves and vibrations to clear the nose, potentially easing sinus pressure and pain. Regular use of SinuSonic has been linked to better sinus drainage, possibly reducing facial pain and pressure. ^{1 3 5 6 7}

Who Is on the Research Team?

Amar Miglani, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with facial pain or pressure lasting more than 3 months, who are generally healthy and can give informed consent. It's not for pregnant individuals, those recently ill with a respiratory infection, allergic to silicone, used nasal decongestants in the last week, had recent sinus surgery, have nasal polyps or signs of sinusitis.

Inclusion Criteria

You have had constant facial pain or pressure for more than 3 months.

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.

Exclusion Criteria

Known pregnancy.

You have had a cold or similar illness in the past 2 weeks.

You are allergic to silicone or any part of the device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SinuSonic or sham device for 2 minutes twice daily

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Device
• SinuSonic

Trial Overview The study tests if SinuSonic—a device combining acoustic vibration and oscillating expiratory pressure—reduces facial pain compared to a sham (placebo) device. Participants will be randomly assigned to use either the real SinuSonic device or a fake one that doesn't provide any treatment effect.

How Is the Trial Designed?

Group I: SinuSonic Group Experimental Treatment 1 Intervention

Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks

Group II: Sham Group Placebo Group 1 Intervention

Subjects will use the sham device for 2 minutes twice daily for 8 weeks

SinuSonic is already approved in United States for the following indications:

Approved in United States as SinuSonic for:

• Nasal congestion
• Sinus congestion
• Allergies
• Rhinologic symptoms

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study involving 5 cadavers, balloon dilation of sinus ostia significantly increased the minimum ostial dimension from 1.73 mm to 3.6 mm, which improved irrigation penetration into the sphenoid sinus, indicating that larger ostial sizes enhance treatment efficacy.

However, the study also found that guidewire insertion often created false passages during maxillary sinus dilation, leading to decreased irrigant penetration in the maxillary sinuses after dilation, highlighting the importance of technique in sinus irrigation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unexpected consequences of transnasal balloon dilation of the maxillary ostium. Brenner, PS., Abadie, WM., Weitzel, EK., et al.[2016]

Nasal saline irrigation is effective for improving mucociliary transport and removing debris in rhinosinusitis and post-surgical care, and this study used computational fluid dynamics to analyze how different factors affect saline flow in the nasal passages.

The research found that the best results for filling the maxillary sinuses with saline occurred when the irrigation was directed into the open nostril while the head was tilted back, highlighting the importance of head position and inflow direction in maximizing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neti pot irrigation volume filling simulation using anatomically accurate in-vivo nasal airway geometry. Salati, H., Bartley, J., Yazdi, SG., et al.[2021]

In a study of 40 patients with allergic rhinitis, adding large-volume, low-pressure nasal irrigation with isotonic saline to existing intranasal corticosteroid therapy significantly improved quality of life, as measured by the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (mRQLQ).

The mRQLQ scores decreased from an average of 36.7 at baseline to 10.1 after 8 weeks of treatment, indicating a substantial improvement, while no significant changes were observed in nasal peak inspiratory flow or adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isotonic saline nasal irrigation is an effective adjunctive therapy to intranasal corticosteroid spray in allergic rhinitis. Nguyen, SA., Psaltis, AJ., Schlosser, RJ.[2022]

A pilot study using computational fluid dynamics (CFD) simulations showed that endoscopic sinus surgery significantly improved irrigation of the frontal sinus, which is crucial for postoperative recovery.

However, the surgery also led to reduced irrigation penetration in the maxillary and ethmoid sinuses, likely due to changes in anatomy from the surgical procedure, highlighting the need for tailored irrigation strategies post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sinus irrigations before and after surgery-Visualization through computational fluid dynamics simulations. Zhao, K., Craig, JR., Cohen, NA., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6718060/

The SinuSonic: reducing nasal congestion with acoustic ... Overall, outcomes were encouraging from this small pilot study with effect sizes in the moderate to large range and no reports of discomfort. It ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03906968

The Safety and Efficacy of a SinuSonic Intervention This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion.

3. sinusonic.com sinusonic.com/blogs/news/sinusonic-announces-presentation-of-double-blind-sham-controlled-trial-data-showing-regular-use-of-the-device-improved-nasal-congestion?srsltid=AfmBOopN8Pxb7UMHMqWp2fHcSQixEFBRSmguhzW08v72BEB_yHxBg5jG

SinuSonic Announces Presentation of Double-Blind, Sham ... SinuSonic Announces Presentation of Double-Blind, Sham-Controlled Trial Data Showing Regular Use of the Device Improved Nasal Congestion. June 9 ...

4. withpower.com withpower.com/trial/phase-headache-8-2022-a4b3b

SinuSonic for Sinus Headache · Info for Participants Research shows that nasal irrigations, like those used in the SinuSonic device, can help manage sinus issues by improving sinus drainage and medication delivery ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10446260/

Treatment of sinus headache using a device that combines ... A previous study looking at use of SinuSonic in the treatment of nasal congestion found significant improvements in objective and subjective ...

6. sinusonic.com sinusonic.com/blogs/news/sinusonic-announces-publication-of-study-results-on-first-of-its-kind-medical-device-for-natural-relief-of-nasal-congestion?srsltid=AfmBOopxpOA5YfsMYqLz_M2853f1bKJf5g2nQUbAg0uzf_ievnVOxhYf

SinuSonic Publishes Result on First of Its Kind Medical ... Results from new study found SinuSonic safe and effective. View the study and results today.

7. americanpharmaceuticalreview.com americanpharmaceuticalreview.com/1315-News/558445-SinuSonic-Clinical-Trial-Data-Shows-Safety-and-Efficacy-for-Nonpharmacologic-Device/

SinuSonic Clinical Trial Data Shows Safety and Efficacy for ... The Nasal Obstruction and Septoplasty Effectiveness (NOSE) score improved from a mean 50.4 to 23.3, a difference which was both statistically ...