A User Study of the Soniflow System for Nasal Congestion Relief

Third Wave Therapeutics50 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasal Congestion

Interventions

Soniflow SystemDEVICE

Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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: 1. 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

Locations (1)

San Francisco Otolaryngology Medical Group

San Francisco, California, United States

Outcomes

Primary Outcomes

Total Nasal Symptom Score

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

Time frame: 20 minutes

Secondary Outcomes

Visual Analog Scale (VAS) for Headache

Visual Analog Scale (VAS) for Headache, using a scale of 0-10. 0 is the minimum and 10 is maximum on this scale. Lower scores mean a better outcome.

Time frame: 20 minutes

Visual Analog Scale (VAS) for Facial Pain

Visual Analog Scale (VAS) for Facial Pain, using a scale of 0-10. 0 is minimum and 10 is the maximum value for this scale. Lower scores mean a better outcome.

Time frame: 20 minutes

Data from ClinicalTrials.gov

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