Nasal Congestion
Conditions
Brief summary
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.
Detailed description
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).
Interventions
DEVICESoniflow System
Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Sponsors
Third Wave Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject is \>18 years of age 2. Subject has had moderate to severe symptoms of nasal congestion for \>3 months (TNSS rating of 2 or 3) 3. Subject has signed IRB-approved informed consent form
Exclusion criteria
1. Subject has neurologic comorbidities 2. Subject has active dental infection 3. Subject is pregnant 4. Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator) 5. Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months 6. Subject has been diagnosed with intracranial hemorrhage within the last 6 months 7. Subject has open scalp wounds or rashes 8. Subject has any history of craniotomy without replacement of a bone flap 9. Subject has elevated sensitivity to sound 10. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Nasal Symptom Score | 20 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Headache | 20 minutes | 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. |
| Visual Analog Scale (VAS) for Facial Pain | 20 minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Treatment using acoustic energy
Soniflow System: Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical Age <=18 years | 0 Participants |
| Age, Categorical Age >=65 years | 4 Participants |
| Age, Categorical Age Between 18 and 65 years | 46 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 30 Participants |
| Total Nasal Symptom Score | 4.1 units on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
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
Population: Adult subjects with nasal congestion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Total Nasal Symptom Score | 2.0 score on a scale |
Secondary
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
Population: adults with nasal congestion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Visual Analog Scale (VAS) for Facial Pain | 0.9 score on a scale (of 0-10) |
Secondary
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
Population: adults with nasal congestion
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Visual Analog Scale (VAS) for Headache | 0.9 score on a scale of 0-10 |