A User Study of the Soniflow System for Nasal Congestion Relief

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

Study Overview

• Status: Completed
• Conditions: Nasal Congestion
• Intervention / Treatment: Device: Soniflow System

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94108
      • San Francisco Otolaryngology Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment using acoustic energy	Device: Soniflow System; Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.; Other Names: Soniflow System to provide nasal congestion relief

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	20 minutes

Collaborators and Investigators

• Sponsor: Third Wave Therapeutics
• Investigators: Principal Investigator: Jacob Johnson, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): January 26, 2021
• Study Completion (Actual): January 26, 2021

Study Registration Dates

• First Submitted: May 23, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No