A User Study of the Soniflow System for Nasal Congestion Relief

Not Applicable

Completed

• Conditions: Nasal Congestion
• Interventions: Device: Soniflow System

• Registration Number: NCT04910139
• Lead Sponsor: Third Wave Therapeutics

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).

Study Timeline

• Study Start: 2020-07-15
• Primary Completion: 2021-01-26
• Study Completion: 2021-01-26
• Study First Submitted: 2021-05-23
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-02
• Results First Submitted: 2023-07-26
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Results First Posted: 2023-10-12
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Soniflow System	Treatment using acoustic energy

Primary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score	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

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Headache	20 minutes	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.
Visual Analog Scale (VAS) for Facial Pain	20 minutes	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.

Trial Locations

Locations (1)

San Francisco Otolaryngology Medical Group; 🇺🇸 San Francisco, California, United States