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

Not Applicable

Active, not recruiting

• Conditions: Facial Pain
• Interventions: Device: Sham Device; Device: SinuSonic

• Registration Number: NCT05479604
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Study Start: 2023-03-22
• Primary Completion: 2024-06-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05
• Study Completion: 2025-06-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Group	Sham Device	Subjects will use the sham device for 2 minutes twice daily for 8 weeks
SinuSonic Group	SinuSonic	Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in facial pain	Baseline, 8 weeks	Measured using a self-reported facial pain visual analogue scale using a 100-mm long line with each end marked with "None possible" on the left, and "Worst" on the right. Participants will identify their pain level by indicating a point on the line between each end. The point will be measured from the "None possible" end and the number of millimeters will be reported as the pain score.
Change in Brief Pain Inventory Short Form	Baseline, 8 weeks	Measured using the Brief Pain Inventory Short Form (BPI-SF). Self reported questionnaire consisting of 12 questions asking participants to rate pain and interference with activity on scales of 0 = no pain/nodes not interfere; 10 = pain as bad as you can image/completely interferes. Total higher scores indicating worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change in nasal obstruction symptoms	Baseline, 8 weeks	Measured using the Nasal Obstruction Symptom Evaluation (NOSE) Score. Self reported survey to assess nasal obstruction on quality of life with 5 questions rating how much of a problem a condition was in the past 1 month on a scale of 0=not a problem; 4=severe problem. Total scores possible scores out of 100 and categorized as Mild (range, 5-25), Moderate (range, 30-50), Severe (range, 55-75), Extreme (range, 80-100) nasal obstruction.
Subjects reporting pain with device use	8 weeks	Number of subjects reporting pain with device use
Subjects reporting epistaxis	8 weeks	Number of subjects reporting epistaxis

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States