Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion
- Conditions
- Nasal Congestion and Inflammations
- Interventions
- Device: Sonu
- Registration Number
- NCT05821842
- Lead Sponsor
- Third Wave Therapeutics
- Brief Summary
To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.
- Detailed Description
Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 18 years of age and older
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Control Group Sonu Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu. Sonu Treatment Group Sonu Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu.
- Primary Outcome Measures
Name Time Method Primary Effectiveness 2 weeks Change in nasal congestion sub-score compared to baseline. The nasal congestion sub-score is reported on a scale of 0-3. 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes.
- Secondary Outcome Measures
Name Time Method Secondary Effectiveness 2 weeks Change in total nasal symptom score (TNSS) compared to baseline. The TNSS is the sum of four (4) symptom sub-scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each self-rated by the subject using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. TNSS scores are reported on a scale of 0-12. 0 is the minimum and 12 is the maximum. Higher scores mean worse outcomes.
Trial Locations
- Locations (1)
San Francisco Otolaryngology Medical Group
🇺🇸San Francisco, California, United States