The Safety and Efficacy of a SinuSonic Intervention

Not Applicable

Completed

• Conditions: Nasal Congestion
• Interventions: Device: SinuSonic Device

• Registration Number: NCT03906968
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion. SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. This device is held over the nose for 3 minutes. This study will use patient responses to measure how effective SinuSonic devices are in treating these moderate to severe congestion in adults. The study will consist of 40 subjects at the Medical University of South Carolina and will take place over the course of 4 to 6 weeks starting with a baseline assessment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-26
• Study Start: 2019-03-31
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-16
• Results First Submitted: 2020-12-07
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-21
• Last Update Submitted: 2021-04-21
• Results First Posted: 2021-04-22
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Adults ≥18 years of age
2. Complaints of nasal congestion present for 2 weeks or more and a qualifying nasal congestion score of >5 (10 point VAS scale)

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Exclusion Criteria

1. Fixed structural cause of nasal congestion (moderate or severe septal deviation, moderate or severe nasal valve collapse, Grade 3-4 polyp)
2. Inability to read and understand English
3. Allergic sensitivity to silicone or any other component of device
4. History of severe nose bleeding within last 3 months
5. Anticoagulation (Aspirin is acceptable)
6. Known pregnancy
7. Current nasal crusting or ulceration revealed on rhinoscopy
8. Inability to perform treatment due to underlying medical condition
9. Topical decongestant use in last week

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SinuSonic Device	SinuSonic Device	SinuSonic Device used twice a day for four to six weeks.

Primary Outcome Measures

Name	Time	Method
Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks	Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks	Change from baseline to week 6 in subject congestion symptom severity, as measured by the Total Nasal Symptom Score (TNSS, range 0-3). Where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 15.

Secondary Outcome Measures

Name	Time	Method
Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score	Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks	Change from baseline to week 6 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22). SNOT-22 is a subject-completed questionnaire that consists of 22 questions. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The total score can range from 0-110, 0 being the best and 110 being the worst.
Change in Visual Analog Scale (VAS)	Visual Analog Scale (VAS) score at 4 to 6 Weeks	The visual analog scale (VAS) for rhinosinusitis is used to evaluate the total severity. The subject is asked to indicate on a VAS the answer to the question: "How troublesome are your symptoms of rhinosinusitis?" Subject will assess Nasal symptoms using a 10 cm Visual Analog Scale for each symptom, 0=not troublesome and 10 = the worst imaginable. The disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm): * Mild = VAS 0-3; * Moderate = VAS \> 3-7; * Severe = VAS \> 7-10
Change in Peak Nasal Inspiratory Flow Test (PNIF Test)	Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks	Change from baseline to week 2 in subject nasal airway obstruction, as measure by the Peak Nasal Inspiratory Flow Test (PNIF Test). The PNIF is used to diagnose the patency of the nose.
Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale)	Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks	Change from baseline to week 6 in subject nasal congestion severity, as measured by the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale). The NOSE scale is a subject-completed questionnaire that consists of 5 questions. Each item is rated as follows: 0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem. The total score can range from 0-100, 0 being the best and 100 being the worst.

Trial Locations

Locations (1)

Sinus Center - Medical Univesity of South Carolina; 🇺🇸 Charleston, South Carolina, United States