Nasal Congestion and Inflammations
Conditions
Brief summary
To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.
Interventions
DEVICEAcoustic Resonance (Sound) Therapy
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
Sponsors
Third Wave Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | 2 weeks | Safety |
| Reduction in nasal congestion subscore | 2 weeks | Effectiveness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2 weeks | Safety |
| Total Nasal Symptom Score (TNSS) | 2 weeks | — |
Countries
United States
Outcome results
None listed