An interventional study of Soniflow System in Nasal Congestion, sponsored by Third Wave Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by Third Wave Therapeutics · Not applicable, Interventional, and Treatment
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.
The Soniflow System is a non-invasive device to provide rapid relief of nasal congestion. It consists of a headband with ultrasound transducers (hardware) coupled to a Smartphone application (software).
Third Wave Therapeutics is the lead sponsor of 5 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment using acoustic energy
Device: Soniflow System
Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Also known as: Soniflow System to provide nasal congestion relief
Total Nasal Symptom Score
TNSS is a measure of nasal congestion, measured as the sum of four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe). The minimum TNSS value is 0. The maximum TNSS value is 12. Lower TNSS score means a better outcome
Time frame: 20 minutes
Visual Analog Scale (VAS) for Headache
Visual Analog Scale (VAS) for Headache, using a scale of 0-10. 0 is the minimum and 10 is maximum on this scale. Lower scores mean a better outcome.
Time frame: 20 minutes
Visual Analog Scale (VAS) for Facial Pain
Visual Analog Scale (VAS) for Facial Pain, using a scale of 0-10. 0 is minimum and 10 is the maximum value for this scale. Lower scores mean a better outcome.
Time frame: 20 minutes
| Milestone | Treatment |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
TNSS is a measure of nasal congestion, measured as the sum of four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe). The minimum TNSS value is 0. The maximum TNSS value is 12. Lower TNSS score means a better outcome
| score on a scale | Treatment |
|---|---|
| Total Nasal Symptom Score | 2.0 (1.6 to 2.5) |
Visual Analog Scale (VAS) for Headache, using a scale of 0-10. 0 is the minimum and 10 is maximum on this scale. Lower scores mean a better outcome.
| score on a scale of 0-10 | Treatment |
|---|---|
| Visual Analog Scale (VAS) for Headache | 0.9 (0.4 to 1.5) |
Visual Analog Scale (VAS) for Facial Pain, using a scale of 0-10. 0 is minimum and 10 is the maximum value for this scale. Lower scores mean a better outcome.
| score on a scale (of 0-10) | Treatment |
|---|---|
| Visual Analog Scale (VAS) for Facial Pain | 0.9 (0.5 to 1.5) |
Collected over 1 day, acute study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
Adult subjects with nasal congestion
| Age, Categorical(Participants) | Treatment |
|---|---|
| Age — <=18 years | 0 |
| Age — Between 18 and 65 years | 46 |
| Age — >=65 years | 4 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 20 |
| Male | 30 |
| Ethnicity (NIH/OMB)(Participants) | Treatment |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 46 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| United States | 50 |
| Total Nasal Symptom Score(units on a scale) | Treatment |
|---|---|
| Mean | 4.1 (3.5 to 4.6) |
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Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Third Wave Therapeutics