Effects of SinuSonic on Psychological and Physical Well-Being
- Conditions
- Nasal Congestion and InflammationsSinus Congestion Chronic
- Registration Number
- NCT06268730
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - 18 years or older;<br><br> - US resident;<br><br> - Currently experiencing symptoms of nasal congestion that have persisted at least 2<br> weeks. Symptom severity must be rated at least 5, on a visual scale ranging from 1<br> to 10, as included in a question in the Eligibility Screening.<br><br>Exclusion Criteria:<br><br> - Previous use of the SinuSonic device.<br><br> - Meeting any of the conditions listed under the Safety and Warnings for using the<br> SinuSonic device:<br><br> 1. Current or history of breathing problems (i.e., asthma, chronic obstructive<br> pulmonary disorder (COPD), chronic bronchitis, emphysema, pneumonia, pleural<br> effusion, lung cancer, cancer of the throat or upper airway)<br><br> 2. Current or history of circulatory problems (i.e., active nose bleed, heart<br> arrhythmia, coronary artery disease, congestive heart failure, heart attack)<br><br> 3. Other conditions, specified as brain tumor, moderate to severe ear pain, fever<br> greater than 101 degrees<br><br> 4. Pregnant or nursing women
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale;Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
- Secondary Outcome Measures
Name Time Method Change in the Body Perception Questionnaire;Change in the Total Nasal Symptom Score;Change in the Patient Global Impression of Change;Adverse Traumatic Experiences Survey at Baseline;Short Form Health Survey (SF-20) at Baseline