N/A
Completed N=50
A User Study of the Soniflow System for Nasal Congestion Relief
Nasal Congestion
Source: ClinicalTrials.gov NCT04910139 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Total Nasal Symptom Score — 2.0 score on a scale
Summary
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Nasal Symptom Score |
2.0 | — |
| SECONDARY Visual Analog Scale (VAS) for Headache |
0.9 | — |
| SECONDARY Visual Analog Scale (VAS) for Facial Pain |
0.9 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04910139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.