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Completed

NCT Number: NCT04910139

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.

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Key information

Conditions

Nasal Congestion Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Otolaryngology Medical Group

San Francisco, California, 94108, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is >18 years of age
  • Subject has had moderate to severe symptoms of nasal congestion for >3 months (TNSS rating of 2 or 3)
  • Subject has signed IRB-approved informed consent form

Exclusion criteria

  • Subject has neurologic comorbidities
  • Subject has active dental infection
  • Subject is pregnant
  • Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
  • Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
  • Subject has been diagnosed with intracranial hemorrhage within the last 6 months
  • Subject has open scalp wounds or rashes
  • Subject has any history of craniotomy without replacement of a bone flap
  • Subject has elevated sensitivity to sound
  • Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk

Treatment and study plan

Soniflow System

Device

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

Primary outcomes

  1. Total Nasal Symptom Score

    Time frame: 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 outcomes

  1. Visual Analog Scale (VAS) for Headache

    Time frame: 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.

  2. Visual Analog Scale (VAS) for Facial Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Third Wave Therapeutics

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2021
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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