The Safety and Efficacy of a SinuSonic Intervention

NCT03906968 | Completed Results FDA Device

• 1 other identifier: Pro00083883
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Congestion

Outcome Measures

Primary Outcomes (1)

• Change in 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.

  Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks

Secondary Outcomes (4)

• Change in Peak Nasal Inspiratory Flow Test (PNIF Test)

  Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks

• Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score

  Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks

• Change in Visual Analog Scale (VAS)

  Visual Analog Scale (VAS) score at 4 to 6 Weeks

• Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale)

  Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks

Other Outcomes (2)

• Safety Descriptive About Occurrence of Adverse Events

  4 to 6 Weeks

• Evaluation of Results of General Physical Examination

  4 to 6 Weeks

Study Arms (1)

SinuSonic Device

EXPERIMENTAL

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

Device: SinuSonic Device

Interventions

SinuSonic Device DEVICE

A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion

SinuSonic Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Sinus Center - Medical Univesity of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 32104962 DERIVED

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Zachary M. Soler
• Organization: MUSC

solerz@musc.edu

(843) 792-3531

Study Officials

• Zachary M Soler

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 8, 2019
• Study Start: March 31, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 16, 2019
• Last Updated: April 22, 2021
• Results First Posted: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)