Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion

August 31, 2023 updated by: Third Wave Therapeutics
Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an interventional study designed to gather data on real world utilization of Acoustic Resonance Therapy for treating moderate to severe nasal congestion

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94108
        • Recruiting
        • San Francisco Otolaryngology Medical Group
        • Contact:
          • Jacob Johnson, MD
          • Phone Number: 415-362-5443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age and older
  • Present with symptoms of chronic nasal congestion
  • Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion Criteria:

  • Head, nasal or sinus surgery within 3 months
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Participants will receive Acoustic Resonance Therapy using the Sonu headband and App, twice a day, for 90 days
Device: Sonu Acoustic Resonance Therapy
Participants will receive Sonu treatment twice a day for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly Utilization-Frequency
Time Frame: 90 days
Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week
90 days
Weekly Utilization-Duration
Time Frame: 90 days
Weekly utilization of Sonu treatment, measured as the duration of treatment received per week
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Nasal Symptom Score (TNSS)
Time Frame: 90 days
24-hour TNSS; Minimum score=0 (no symptoms), Maximum score=12 (severe symptoms). Lower scores are better and reflect less symptoms.
90 days
Asthma Control
Time Frame: 90 days
Asthma Control Test (ACT) Score; Minimum score = 5 (poor control of asthma). Maximum score = 25 (complete control of asthma). Higher scores reflect greater asthma control.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Wave Therapeutics

Investigators

  • Principal Investigator: Jacob Johnson, MD, San Francisco Otolaryngology Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CP-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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