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Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

NCT06773013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-09-10

No results posted yet for this study

Summary

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

Conditions

  • Nasal Congestion and Inflammations

Interventions

DEVICE

Acoustic 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 & Collaborators

  • Third Wave Therapeutics

    lead INDUSTRY

Principal Investigators

  • Alan Greene, MD · Crescendo MD

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2025-03-16
Completion
2025-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06773013 on ClinicalTrials.gov