Upper Respiratory Infection
Conditions
Brief summary
This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 2 aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8 week fall URI season. Subjects will use an active device (positive expiratory pressure and 128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8 weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community acquired viral URIs. Subjects will use active or sham device as above.
Interventions
DEVICESinuSonic Device
A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
DEVICESham SinuSonic Device
Sham positive expiratory pressure intervention using the SinuSonic Device.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.
Exclusion criteria
* Any transient ENT condition that may impact upper airway to include acute sinusitis or otitis. * Any upper respiratory illness within last 2 weeks * TSS will be measured at baseline as described above and must be \<9 for inclusion (Eccles etal). * Topical decongestant use in last week * Current nasal crusting or history of ulceration or perforation * History of severe nose bleeding within last 3 months * Known pregnancy * Immunosuppressed condition or on immune modulating medications such as prednisone or chemotherapy * Allergic sensitivity to silicone or any other component of device * Inability to read and understand English * Inability to perform treatment due to underlying medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Symptoms Score (TSS) | 60 Days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| 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. | 13 |
| Total | 52 |
Baseline characteristics
| Characteristic | SinuSonic Device | Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 12 Participants | 47 Participants |
| Age, Continuous | 46.2 years | 48.5 years | 46.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 13 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 11 Participants | 50 Participants |
| Sex: Female, Male Female | 27 Participants | 7 Participants | 34 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 13 |
| other Total, other adverse events | 1 / 39 | 0 / 13 |
| serious Total, serious adverse events | 0 / 39 | 0 / 13 |
Outcome results
Primary
Total Symptoms Score (TSS)
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.
Time frame: 60 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic Device | Total Symptoms Score (TSS) | 0.503 scores | Standard Deviation 0.501 |
| Sham | Total Symptoms Score (TSS) | 0.843 scores | Standard Deviation 0.569 |