Using SinuSonic to improve well-being in adults with nasal congestion
Effects of SinuSonic on Psychological and Physical Well-Being In Adults With Nasal/Sinus Congestion
This study is testing whether using the SinuSonic device for 5 weeks can help adults with chronic nasal congestion feel better both physically and mentally.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06268730 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of the SinuSonic device on both psychological and physical well-being in adults suffering from chronic nasal congestion. Participants will complete self-report measures assessing their health and mental state before and after a 5-week period of using the device twice daily. The study also aims to explore the relationship between autonomic reactivity and psychological well-being, as well as the impact of adverse experiences on health outcomes. Data collection will occur remotely, allowing participants to use the device in their own homes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently experiencing nasal congestion symptoms lasting at least two weeks.
Not a fit: Patients with a history of significant breathing or circulatory problems, or those who have previously used the SinuSonic device, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from chronic nasal congestion by alleviating both physical symptoms and psychological distress.
How similar studies have performed: While this approach is relatively novel, similar studies exploring the relationship between physical symptoms and psychological well-being have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older; * US resident; * Currently experiencing symptoms of nasal congestion that have persisted at least 2 weeks. Symptom severity must be rated at least 5, on a visual scale ranging from 1 to 10, as included in a question in the Eligibility Screening. Exclusion Criteria: * Previous use of the SinuSonic device. * Meeting any of the conditions listed under the "Safety and Warnings" for using the SinuSonic device: 1. Current or history of breathing problems (i.e., asthma, chronic obstructive pulmonary disorder (COPD), chronic bronchitis, emphysema, pneumonia, pleural effusion, lung cancer, cancer of the throat or upper airway) 2. Current or history of circulatory problems (i.e., active nose bleed, heart arrhythmia, coronary artery disease, congestive heart failure, heart attack) 3. Other conditions, specified as brain tumor, moderate to severe ear pain, fever greater than 101 degrees 4. Pregnant or nursing women
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Keri J Heilman, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Keri J Heilman, PhD
- Email: keri_heilman@med.unc.edu
- Phone: 913-802-2168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.