A User Study of the Soniflow System for Nasal Congestion Relief
Purpose
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.
Condition
- Nasal Congestion
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
Treatment using acoustic energy |
|
Recruiting Locations
More Details
- NCT ID
- NCT04910139
- Status
- Completed
- Sponsor
- Third Wave Therapeutics
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).