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

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

Official Title
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Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure: Randomized Controlled Trial

Conditions
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Facial Pain

Intervention / Treatment
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* Device: SinuSonic
* Device: Sham Device


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SinuSonic Group<br>Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks | Device: SinuSonic<br>* Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.<br>|
| Sham Comparator: Sham Group<br>Subjects will use the sham device for 2 minutes twice daily for 8 weeks | Device: Sham Device<br>* Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in facial pain | 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 millimters will be reported as the pain score. | Baseline, 8 weeks | 
| Change in Brief Pain Inventory Short Form | 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. | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects reporting pain with device use | Number of subjects reporting pain with device use | 8 weeks | 
| Subjects reporting epistaxis | Number of subjects reporting epistaxis | 8 weeks | 
| Change in nasal obstruction symptoms | 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. | Baseline, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Pressure