A User Study of the Soniflow System for Nasal Congestion Relief

Third Wave Therapeutics

Status: Completed

Conditions: Nasal Congestion

Treatments: Device: Soniflow System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04910139

CP-001

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment using acoustic energy

Treatment:

Device: Soniflow System