Trial Outcomes & Findings for Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI) (NCT NCT04468204)

Last Updated: 2022-12-20

Results Overview

The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom. The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness. The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms) Minimum score=0; maximum score=27.

Recruitment status

COMPLETED

Study phase

Target enrollment

95 participants

Primary outcome timeframe

60 Days

Results posted on

2022-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	SinuSonic Device SinuSonic device used for 1 min three times a day for 8 weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.	Sham Sham SinuSonic device used for 1 min three times a day for 8 weeks. Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.
Overall Study STARTED	39	13
Overall Study COMPLETED	39	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SinuSonic Device n=39 Participants SinuSonic device used for 1 min three times a day for 8 weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.	Sham n=13 Participants Sham SinuSonic device used for 1 min three times a day for 8 weeks. Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	12 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	46.2 years n=5 Participants	48.5 years n=7 Participants	46.8 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	7 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	13 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	11 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 Days

Outcome measures

Outcome measures
Measure	SinuSonic Device n=39 Participants SinuSonic device used for 1 min three times a day for 8 weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.	Sham n=13 Participants Sham SinuSonic device used for 1 min three times a day for 8 weeks. Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.
Total Symptoms Score (TSS)	0.503 scores Standard Deviation 0.501	0.843 scores Standard Deviation 0.569

Adverse Events

SinuSonic Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SinuSonic Device n=39 participants at risk SinuSonic device used for 1 min three times a day for 8 weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.	Sham n=13 participants at risk Sham SinuSonic device used for 1 min three times a day for 8 weeks. Sham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.
Ear and labyrinth disorders Pain	2.6% 1/39 • Number of events 1 • 8 weeks	0.00% 0/13 • 8 weeks

Additional Information

Director of Clinical Research

Department of Otolaryngology - Head and Neck Surgery

Phone: (843)792-1356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place