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Completed

NCT Number: NCT03906968

The Safety and Efficacy of a SinuSonic Intervention

This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion. SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. This device is held over the nose for 3 minutes. This study will use patient responses to measure how effective SinuSonic devices are in treating these moderate to severe congestion in adults. The study will consist of 40 subjects at the Medical University of South Carolina and will take place over the course of 4 to 6 weeks starting with a baseline assessment.

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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

Sinus Center - Medical Univesity of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults ≥18 years of age
  • Complaints of nasal congestion present for 2 weeks or more and a qualifying nasal congestion score of >5 (10 point VAS scale)

Exclusion criteria

  • Fixed structural cause of nasal congestion (moderate or severe septal deviation, moderate or severe nasal valve collapse, Grade 3-4 polyp)
  • Inability to read and understand English
  • Allergic sensitivity to silicone or any other component of device
  • History of severe nose bleeding within last 3 months
  • Anticoagulation (Aspirin is acceptable)
  • Known pregnancy
  • Current nasal crusting or ulceration revealed on rhinoscopy
  • Inability to perform treatment due to underlying medical condition
  • Topical decongestant use in last week

Treatment and study plan

SinuSonic Device

Device

A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion

Primary outcomes

  1. Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks

    Time frame: Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks

    Change from baseline to week 6 in subject congestion symptom severity, as measured by the Total Nasal Symptom Score (TNSS, range 0-3). Where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 15.

Secondary outcomes

  1. Change in Peak Nasal Inspiratory Flow Test (PNIF Test)

    Time frame: Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks

    Change from baseline to week 2 in subject nasal airway obstruction, as measure by the Peak Nasal Inspiratory Flow Test (PNIF Test). The PNIF is used to diagnose the patency of the nose.

  2. Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score

    Time frame: Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks

    Change from baseline to week 6 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22). SNOT-22 is a subject-completed questionnaire that consists of 22 questions. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The total score can range from 0-110, 0 being the best and 110 being the worst.

  3. Change in Visual Analog Scale (VAS)

    Time frame: Visual Analog Scale (VAS) score at 4 to 6 Weeks

    The visual analog scale (VAS) for rhinosinusitis is used to evaluate the total severity. The subject is asked to indicate on a VAS the answer to the question: "How troublesome are your symptoms of rhinosinusitis?" Subject will assess Nasal symptoms using a 10 cm Visual Analog Scale for each symptom, 0=not troublesome and 10 = the worst imaginable. The disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm):

    • Mild = VAS 0-3
    • Moderate = VAS > 3-7
    • Severe = VAS > 7-10

  4. Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale)

    Time frame: Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks

    Change from baseline to week 6 in subject nasal congestion severity, as measured by the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale). The NOSE scale is a subject-completed questionnaire that consists of 5 questions. Each item is rated as follows: 0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem. The total score can range from 0-100, 0 being the best and 100 being the worst.

Other outcomes

  1. Safety Descriptive About Occurrence of Adverse Events

    Time frame: 4 to 6 Weeks

    Safety will be evaluated by the Adverse events occurence

  2. Evaluation of Results of General Physical Examination

    Time frame: 4 to 6 Weeks

    Collection of safety data throughout the whole study period

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

SinuSonic Study for Adults With Nasal Congestion

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2019
Registry last updated
Apr 22, 2021

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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