Treatment for pediatric nasal congestion using sound therapy
Safety and Effectiveness of Sonu Acoustic Resonance Therapy for the Treatment of Pediatric Patients With Moderate to Severe Nasal Congestion.
NA · Third Wave Therapeutics · NCT06773013
This study is testing if a sound therapy called Sonu can safely help kids and young adults aged 12 to 21 who have had bad nasal congestion for at least a month feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Third Wave Therapeutics (industry) |
| Locations | 1 site (Portola Valley, California) |
| Trial ID | NCT06773013 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of Sonu, an acoustic resonance therapy, for treating moderate to severe nasal congestion in pediatric patients aged 12 to 21 years. Participants must have experienced nasal congestion symptoms for at least one month and meet specific severity criteria. The intervention involves the application of sound therapy to alleviate symptoms associated with nasal congestion. The study will assess both the safety of the treatment and its impact on reducing congestion.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 12 to 21 who have had nasal congestion symptoms for over a month and meet the severity criteria.
Not a fit: Patients with recent nasal or sinus surgeries, current sinus infections, or a history of nasal polyps may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for alleviating nasal congestion in children and young adults.
How similar studies have performed: While this approach is relatively novel, similar acoustic therapies have shown promise in other contexts, but specific studies on this method for nasal congestion are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric subjects between the ages of 12 to 21 years * Present with symptoms of nasal congestion for 1 month or more prior to treatment * 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 * Sinus infection diagnosed within the last month, or rhinitis medicamentosa * Documented history of nasal polyposis or mass * Pregnancy
Where this trial is running
Portola Valley, California
- Crescendo MD — Portola Valley, California, United States (RECRUITING)
Study contacts
- Principal investigator: Alan Greene, MD — Crescendo MD
- Study coordinator: Katie DeSutter
- Email: katie@soundhealth.life
- Phone: 559-696-1926
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.
Conditions: Nasal Congestion and Inflammations