A User Study of the Soniflow System for Nasal Congestion Relief

Study Overview
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Brief Summary
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The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.

Detailed Description
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The Soniflow System is a non-invasive device to provide rapid relief of nasal congestion. It consists of a headband with ultrasound transducers (hardware) coupled to a Smartphone application (software).

Official Title
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A User Study of the Soniflow System for Nasal Congestion Relief

Conditions
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Nasal Congestion

Intervention / Treatment
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* Device: Soniflow System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is >18 years of age Subject has had moderate to severe symptoms of nasal congestion for >3 months (TNSS rating of 2 or 3) Subject has signed IRB-approved informed consent form Exclusion Criteria: Subject has neurologic comorbidities Subject has active dental infection Subject is pregnant Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator) Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months Subject has been diagnosed with intracranial hemorrhage within the last 6 months Subject has open scalp wounds or rashes Subject has any history of craniotomy without replacement of a bone flap Subject has elevated sensitivity to sound Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment using acoustic energy | Device: Soniflow System<br>* Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.<br>* Other names: Soniflow System to provide nasal congestion relief;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score | TNSS is a measure of nasal congestion, measured as the sum of four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe). The minimum TNSS value is 0. The maximum TNSS value is 12. Lower TNSS score means a better outcome | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) for Headache | Visual Analog Scale (VAS) for Headache, using a scale of 0-10. 0 is the minimum and 10 is maximum on this scale. Lower scores mean a better outcome. | 20 minutes | 
| Visual Analog Scale (VAS) for Facial Pain | Visual Analog Scale (VAS) for Facial Pain, using a scale of 0-10. 0 is minimum and 10 is the maximum value for this scale. Lower scores mean a better outcome. | 20 minutes |