A User Study of the Soniflow System for Nasal Congestion Relief

Nasal Congestion Clinical Trial

Official title:

A User Study of the Soniflow System for Nasal Congestion Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04910139
• Other study ID #: CP-001
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: January 26, 2021

Study information

• Verified date: October 2023
• Source: Third Wave Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Congestion

Intervention

Device:
• Soniflow System
Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.

Locations

Country	Name	City	State
United States	San Francisco Otolaryngology Medical Group	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Third Wave Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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