SinuSonic for Sinus Headache

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

27 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.

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 data supports the effectiveness of the SinuSonic treatment for sinus headache?

Research shows that nasal irrigations, like those used in the SinuSonic device, can help manage sinus issues by improving sinus drainage and medication delivery, especially after sinus surgery. This suggests that similar treatments may help relieve sinus headaches by enhancing sinus function. ^{1 2 3 4 5}

How is the SinuSonic treatment different from other treatments for sinus headache?

SinuSonic is unique because it uses a combination of sound waves and gentle pressure to help clear sinus congestion, unlike traditional treatments that often rely on medication or surgery. This non-invasive approach may offer relief without the need for drugs or surgical intervention. ^{2 6 7 8 9}

Research Team

Amar Miglani, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sinus irrigations before and after surgery-Visualization through computational fluid dynamics simulations. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of intranasal medication delivery devices before and after functional endoscopic sinus surgery using Phacon sinus surgery models. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Neti pot irrigation volume filling simulation using anatomically accurate in-vivo nasal airway geometry. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Unexpected consequences of transnasal balloon dilation of the maxillary ostium. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Isotonic saline nasal irrigation is an effective adjunctive therapy to intranasal corticosteroid spray in allergic rhinitis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sinus penetration of saline solution irrigation and atomizer in a cadaveric polyp and allergic fungal sinusitis model. [2020]

7. China pubmed.ncbi.nlm.nih.gov

[Clinical analysis of nasal mucosa contact headache]. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

[Alpha-mimetic effects on nasal mucosa in magnetic resonance tomography]. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Functional endoscopic sinus surgery. [2016]