Trial Outcomes & Findings for The Safety and Efficacy of a SinuSonic Intervention (NCT NCT03906968)

Last Updated: 2021-04-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

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

Results posted on

2021-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	SinuSonic Device SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety and Efficacy of a SinuSonic Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SinuSonic Device n=40 Participants SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	39.1 Years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants
visual analogue scale (VAS)	5.8 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants
Total Nasal Symptom Score (TNSS)	7.2 units on a scale STANDARD_DEVIATION 3.5 • n=5 Participants
Nasal Obstruction and Septoplasty Effectiveness (NOSE) score	50.4 units on a scale STANDARD_DEVIATION 19.9 • n=5 Participants
22-item Sino-Nasal Outcome Test (SNOT-22)	31.7 units on a scale STANDARD_DEVIATION 20.3 • n=5 Participants
peak nasal inspiratory flow (PNIF)	79.5 L/min STANDARD_DEVIATION 43.6 • n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	SinuSonic Device n=40 Participants SinuSonic Device used twice a day for four to six weeks. 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) at 4 to 6 Weeks	3.5 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SinuSonic Device n=40 Participants SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Change in Peak Nasal Inspiratory Flow Test (PNIF Test)	104.5 L/min Standard Deviation 41.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SinuSonic Device n=40 Participants SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score	14.2 score on a scale Standard Deviation 12.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SinuSonic Device n=40 Participants SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Change in Visual Analog Scale (VAS)	2.6 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SinuSonic Device n=40 Participants SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale)	23.3 score on a scale Standard Deviation 17.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 to 6 Weeks

Safety will be evaluated by the Adverse events occurence

Outcome measures

Outcome measures
Measure	SinuSonic Device n=40 Participants SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Safety Descriptive About Occurrence of Adverse Events	0 reported adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 to 6 Weeks

Collection of safety data throughout the whole study period

Outcome measures

Outcome data not reported

Adverse Events

SinuSonic Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Zachary M. Soler

MUSC

Phone: (843) 792-3531

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place