Clinical trial NCT03906968: The Safety and Efficacy of a SinuSonic Intervention
Official title: SinuSonic Study for Adults With Nasal Congestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Congestion
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

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

Primary outcomes:
measure: Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks
timeFrame: Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks
Secondary outcomes:
measure: Change in Peak Nasal Inspiratory Flow Test (PNIF Test)
timeFrame: Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks
measure: Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score
timeFrame: Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks
measure: Change in Visual Analog Scale (VAS)
timeFrame: Visual Analog Scale (VAS) score at 4 to 6 Weeks
measure: Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale)
timeFrame: Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks
Other outcomes:
measure: Safety Descriptive About Occurrence of Adverse Events
timeFrame: 4 to 6 Weeks
measure: Evaluation of Results of General Physical Examination
timeFrame: 4 to 6 Weeks
Locations:
city: Charleston
country: United States
facility: Sinus Center - Medical Univesity of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Zachary M Soler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soler ZM, Nguyen SA, Salvador C, Lackland T, Desiato VM, Storck K, Schlosser RJ. A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion. Int Forum Allergy Rhinol. 2020 May;10(5):610-618. doi: 10.1002/alr.22537. Epub 2020 Feb 27.