Upper Respiratory InfectionNCT04468204
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)
A study testing SinuSonic Device in people with Upper Respiratory Infection, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Respiratory Infection
- What is being tested?
- SinuSonic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (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 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.
- Conditions
- Upper Respiratory Infection
- Being tested
- SinuSonic Device, Sham SinuSonic Device
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinuSonic DeviceDevice
A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
Sham SinuSonic DeviceDevice
Also called Sham
Sham positive expiratory pressure intervention using the SinuSonic Device.
| Study group | Role | What they receive |
|---|---|---|
| SinuSonic Device | Experimental | SinuSonic device used for 1 min three times a day for 8 weeks. Receives: Device: SinuSonic Device |
| Sham | Sham comparator | Sham SinuSonic device used for 1 min three times a day for 8 weeks. Receives: Device: Sham SinuSonic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaun A. Nguyen, MD, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468204
- Sponsor's protocol ID
- Pro00100980
- Status last verified
- Nov 2022
- First submitted
- 8 Jul 2020
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not Applicable. The investigators plan to publish this study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)
- ClinicalTrials.gov ID
- NCT04468204
- Acronym / sponsor ID
- Pro00100980
- Conditions
- Upper Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 20 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SinuSonic Device | Experimental | Device: SinuSonic DeviceSinuSonic device used for 1 min three times a day for 8 weeks. |
| Sham | Sham comparator | Device: Sham SinuSonic DeviceSham SinuSonic device used for 1 min three times a day for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SinuSonic DeviceA medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. | Device | SinuSonic Device |
| Sham SinuSonic DeviceAlso: ShamSham positive expiratory pressure intervention using the SinuSonic Device. | Device | Sham |
Primary outcome
Total Symptoms Score (TSS)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not Applicable. The investigators plan to publish this study.
Related trials for Upper Respiratory Infection
Not yet recruitingPhase 4
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
Healthy Volunteers, Sympathetic Activity
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SinuSonic Device in people with Upper Respiratory Infection, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Symptoms Score (TSS) (time frame: 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.