Status:
COMPLETED
A User Study of the Soniflow System for Nasal Congestion Relief
Lead Sponsor:
Third Wave Therapeutics
Conditions:
Nasal Congestion
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Subject is \>18 years of age
- Subject has had moderate to severe symptoms of nasal congestion for \>3 months (TNSS rating of 2 or 3)
- Subject has signed IRB-approved informed consent form
Exclusion
- Subject has neurologic comorbidities
- Subject has active dental infection
- Subject is pregnant
- Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
- Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
- Subject has been diagnosed with intracranial hemorrhage within the last 6 months
- Subject has open scalp wounds or rashes
- Subject has any history of craniotomy without replacement of a bone flap
- Subject has elevated sensitivity to sound
- Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04910139
Start Date
July 15 2020
End Date
January 26 2021
Last Update
October 12 2023
Active Locations (1)
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1
San Francisco Otolaryngology Medical Group
San Francisco, California, United States, 94108