Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

Third Wave Therapeutics31 enrolled

Overview

To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasal Congestion and Inflammations

Interventions

Acoustic Resonance (Sound) TherapyDEVICE

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Crescendo MD

Portola Valley, California, United States

Outcomes

Primary Outcomes

Serious adverse events

Safety

Time frame: 2 weeks

Reduction in nasal congestion subscore

Effectiveness

Time frame: 2 weeks

Secondary Outcomes

Adverse events

Safety

Time frame: 2 weeks

Total Nasal Symptom Score (TNSS)

Time frame: 2 weeks

Data from ClinicalTrials.gov

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