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To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ages 12-15 | Other | Pediatric subjects aged 12-15 years |
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| Ages 16-21 | Other | Pediatric subjects aged 16-21 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoustic Resonance (Sound) Therapy | Device | Sonu consists of an acoustic Vibrational Headband worn circumferentially at the level of the forehead; and a Smartphone App, paired to the Headband. The App determines acoustic resonant frequencies of the subject's nasal cavity (using the facial image) and delivers treatment through bone conduction transducers in the headband |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | Safety | 2 weeks |
| Reduction in nasal congestion subscore | Effectiveness | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Safety | 2 weeks |
| Total Nasal Symptom Score (TNSS) | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Greene, MD | Crescendo MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crescendo MD | Portola Valley | California | 94028 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37812532 | Background | Luong AU, Yong M, Hwang PH, Lin BY, Gopi P, Mohan V, Ma Y, Johnson J, Yen DM, DeMera RS, Bleier BS. Acoustic resonance therapy is safe and effective for the treatment of nasal congestion in rhinitis: A randomized sham-controlled trial. Int Forum Allergy Rhinol. 2024 May;14(5):919-927. doi: 10.1002/alr.23284. Epub 2023 Oct 9. |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |