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.
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.
+2 more
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.
+7 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SinuSonic GroupExperimental Treatment1 Intervention
Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks
Group II: Sham GroupPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic FloridaJacksonville, FL
Mayo Clinic ArizonaPhoenix, AZ
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor