A User Study of the Soniflow System for Nasal Congestion Relief

Third Wave Therapeutics1 site in 1 country50 target enrollmentJuly 15, 2020

ConditionsNasal Congestion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nasal Congestion
Sponsor: Third Wave Therapeutics
Enrollment: 50
Locations: 1
Primary Endpoint: Total Nasal Symptom Score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 15, 2020

End Date

January 26, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Third Wave Therapeutics

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Total Nasal Symptom Score

Time Frame: 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