N/A N=50 Treatment

A User Study of the Soniflow System for Nasal Congestion Relief

Nasal Congestion

Bottom Line

View on ClinicalTrials.gov: NCT04910139 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Total Nasal Symptom Score — 2.0 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Soniflow System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Third Wave Therapeutics
Primary completion: Jan 2021

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	—

Summary

The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.

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

View full record on ClinicalTrials.gov →

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.