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

Mayo Clinic

Status: Terminated

Conditions: Facial Pain

Treatments: Device: Sham Device; Device: SinuSonic

Study type: Interventional

Funder types: Other

Identifiers

NCT05479604

22-001904

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• 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.
• Facial pain or pressure for > 3 months of symptom duration.
• Pain/pressure VAS (Visual Analogue Scale) Score of > 5.

Exclusion criteria

• Upper respiratory illness within the last 2 weeks.
• History of severe epistaxis.
• Known pregnancy.
• Allergic sensitivity to silicone or any other component of device.
• Sinonasal surgery in the last 3 months.
• Topical decongestant use in the last week.
• Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.
• Sinusitis on imaging.
• Nasal crusting or ulceration on exam.
• Inability to read or understand English.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups

SinuSonic Group

Experimental group

Description:

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

Treatment:

Device: SinuSonic

Sham Group

Sham Comparator group

Description:

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

Treatment:

Device: Sham Device