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

• Sponsor: Third Wave Therapeutics (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06024564
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.7
• Patients Per Site Per Month: 25.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nasal Congestion	Device: Sonu Acoustic Resonance Therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion
• Actual Study Start Date: Aug 8, 2023
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: May 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Weekly Utilization-Frequency [90 days]

   Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week

2. Weekly Utilization-Duration [90 days]

   Weekly utilization of Sonu treatment, measured as the duration of treatment received per week

Secondary Outcome Measures

1. Total Nasal Symptom Score (TNSS) [90 days]

   24-hour TNSS; Minimum score=0 (no symptoms), Maximum score=12 (severe symptoms). Lower scores are better and reflect less symptoms.

2. Asthma Control [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Otolaryngology Medical Group	San Francisco	California	United States	94108

Sponsors and Collaborators

• Third Wave Therapeutics

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Third Wave Therapeutics
• ClinicalTrials.gov Identifier: NCT06024564
• Other Study ID Numbers: CP-007
• First Posted: Sep 6, 2023
• Last Update Posted: Sep 6, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Sep 6, 2023