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Behavioural Intervention

SinuSonic for Sinus Headache

N/A

Recruiting

Led By Amar Miglani, MD

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Brief Pain Inventory Short Form

Change in facial pain

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,389 Total Patients Enrolled

1 Trials studying Facial Pain

300 Patients Enrolled for Facial Pain

Amar Miglani, MDPrincipal InvestigatorMayo Clinic

Media Library

SinuSonic (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05479604 — N/A

Facial Pain Research Study Groups: SinuSonic Group, Sham Group

Facial Pain Clinical Trial 2023: SinuSonic Highlights & Side Effects. Trial Name: NCT05479604 — N/A

SinuSonic (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05479604 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this trial?

"According to the website, this trial is no longer actively recruiting patients. The original posting date was December 1st, 2022 and the most recent update was on October 26th of the same year. There are 168 other trials that you might consider enrolling in."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure

Amar Miglani 2023. "Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05479604.

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