The Safety and Efficacy of a SinuSonic Intervention
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|ClinicalTrials.gov Identifier: NCT03906968|
Recruitment Status : Completed
First Posted : April 8, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Nasal Congestion||Device: SinuSonic Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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
- 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.
- Safety descriptive about occurrence of adverse events [ Time Frame: 4 to 6 Weeks ]Safety will be evaluated by the Adverse events occurence
- Evaluation of results of general physical examination [ Time Frame: 4 to 6 Weeks ]Collection of safety data throughout the whole study period
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
|United States, South Carolina|
|Sinus Center - Medical Univesity of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Zachary M Soler||Medical University of South Carolina|