Nasal Congestion
Conditions
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
Interventions
DEVICESonu Acoustic Resonance Therapy
Participants will receive Sonu treatment twice a day for 90 days
Sponsors
Third Wave Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed