N/A
N=52
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)
Upper Respiratory Infection
Bottom Line
View on ClinicalTrials.gov: NCT04468204 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Total Symptoms Score (TSS) — 0.503; 0.843 scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SinuSonic Device (Device); Sham SinuSonic Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Symptoms Score (TSS) |
0.503; 0.843 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04468204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.