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Behavioural Intervention
SinuSonic for Sinus Headache
N/A
Waitlist Available
Led By Amar Miglani, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Summary
This trial is testing a new device to see if it can relieve facial pain and pressure better than a placebo device.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves a non-invasive device rather than medication, side effects may include discomfort from using the device itself such as irritation around where it contacts the face or an increase in existing symptoms due to its mechanical action.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Brief Pain Inventory Short Form
Change in facial pain
Secondary study objectives
Change in nasal obstruction symptoms
Subjects reporting epistaxis
Subjects reporting pain with device use
Trial Design
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
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,337 Previous Clinical Trials
3,061,147 Total Patients Enrolled
1 Trials studying Facial Pain
300 Patients Enrolled for Facial Pain
Amar Miglani, M.D.Principal InvestigatorMayo Clinic
Amar Miglani, MDPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a cold or similar illness in the past 2 weeks.You are allergic to silicone or any part of the device.You have used nasal decongestant spray in the past week.You have crusts or sores in your nose.You have had constant facial pain or pressure for more than 3 months.You have signs of sinus problems during a medical exam, such as nasal polyps or sinus inflammation.You are experiencing significant pain or pressure, rated higher than 5 on a scale.You have a history of severe nosebleeds.You have sinusitis shown on imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: SinuSonic Group
- Group 2: Sham Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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