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The Safety and Efficacy of a SinuSonic Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03906968
Recruitment Status : Completed
First Posted : April 8, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nasal Congestion Device: SinuSonic Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SinuSonic Study for Adults With Nasal Congestion
Actual Study Start Date : March 31, 2019
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : December 16, 2019

Arm Intervention/treatment
Experimental: SinuSonic Device
SinuSonic Device used twice a day for four to six weeks.
Device: SinuSonic Device
A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion




Primary Outcome Measures :
  1. Change in Total Nasal Symptom Score (TNSS) [ Time Frame: 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 :
  1. Change in Peak Nasal Inspiratory Flow Test (PNIF Test) [ Time Frame: 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.

  2. Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score [ Time Frame: 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.

  3. Change in Visual Analog Scale (VAS) [ Time Frame: 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

  4. Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) [ Time Frame: 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.


Other Outcome Measures:
  1. Safety descriptive about occurrence of adverse events [ Time Frame: 4 to 6 Weeks ]
    Safety will be evaluated by the Adverse events occurence

  2. Evaluation of results of general physical examination [ Time Frame: 4 to 6 Weeks ]
    Collection of safety data throughout the whole study period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906968


Locations
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United States, South Carolina
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Zachary M Soler Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
Informed Consent Form  [PDF] March 12, 2019


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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03906968    
Other Study ID Numbers: Pro00083883
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not Applicable. We plan to publish this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes