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NCT04468204 · ClinicalTrials.gov registry record · NA
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 95
- Enrollment target
NCT04468204: Completed NA study, sponsored by Medical University of South Carolina.
NCT04468204 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 95 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04468204, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 95 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE SinuSonic Device
- DEVICE Sham SinuSonic Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2021-07-01 |
| Phase | NA |
What the finished NCT04468204 record still lists
NCT04468204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which SinuSonic Device is the first listed.
NCT04468204 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04468204 about?
NCT04468204 is a clinical study titled "Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)". 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 S...
What is the current status of trial NCT04468204?
This trial is currently completed. It is a NA study. The enrollment target is 95 participants. The study started on 2020-10-01. Estimated completion is 2021-07-01.
What interventions are being tested in trial NCT04468204?
The interventions under investigation include: SinuSonic Device (DEVICE), Sham SinuSonic Device (DEVICE).
Who is sponsoring clinical trial NCT04468204?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04468204's enrollment target sits among peer trials
95 931st of 2000 higher than 1,066 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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