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OpenTrials
Completed

NCT Number: NCT06773013

Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

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

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Key information

Conditions

Nasal Congestion and Inflammations Airway Obstruction Inflammation Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Crescendo MD

Portola Valley, California, 94028, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Serious adverse events

    Time frame: 2 weeks

    Safety

  2. Reduction in nasal congestion subscore

    Time frame: 2 weeks

    Effectiveness

Secondary outcomes

  1. Adverse events

    Time frame: 2 weeks

    Safety

  2. Total Nasal Symptom Score (TNSS)

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Third Wave Therapeutics

Industry

Registry information

Official study title

Safety and Effectiveness of Sonu Acoustic Resonance Therapy for the Treatment of Pediatric Patients With Moderate to Severe Nasal Congestion.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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