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NCT06024564 Clinical Trial

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

Nasal Congestion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06024564
Other study ID # CP-007
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 8, 2023
Est. completion date May 30, 2024

Study information
Verified date August 2023
Source Third Wave Therapeutics
Contact Paramesh Gopi, PhD
Phone 408-316-3631
Email pgopi@soundhealth.life
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion

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

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date May 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Sonu Acoustic Resonance Therapy
Participants will receive Sonu treatment twice a day for 90 days

Locations
Country Name City State
United States San Francisco Otolaryngology Medical Group San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Third Wave Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weekly Utilization-Frequency Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week 90 days
Primary Weekly Utilization-Duration Weekly utilization of Sonu treatment, measured as the duration of treatment received per week 90 days
Secondary Total Nasal Symptom Score (TNSS) 24-hour TNSS; Minimum score=0 (no symptoms), Maximum score=12 (severe symptoms). Lower scores are better and reflect less symptoms. 90 days
Secondary Asthma Control 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
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