Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion
- Conditions
- Nasal Congestion
- Interventions
- Device: Sonu Acoustic Resonance Therapy
- Registration Number
- NCT06024564
- Lead Sponsor
- Third Wave Therapeutics
- Brief Summary
Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 121
- 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
- Head, nasal or sinus surgery within 3 months
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interventional Sonu Acoustic Resonance Therapy Participants will receive Acoustic Resonance Therapy using the Sonu headband and App, twice a day, for 90 days
- Primary Outcome Measures
Name Time Method Weekly Utilization-Frequency 90 days Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week
Weekly Utilization-Duration 90 days Weekly utilization of Sonu treatment, measured as the duration of treatment received per week
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
San Francisco Otolaryngology Medical Group
🇺🇸San Francisco, California, United States