Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

NCT06773013 | Completed FDA Device

• 1 other identifier: CP-008
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Serious adverse events

  Safety

  2 weeks

• Reduction in nasal congestion subscore

  Effectiveness

  2 weeks

Secondary Outcomes (2)

• Adverse events

  2 weeks

• Total Nasal Symptom Score (TNSS)

  2 weeks

Study Arms (2)

Ages 12-15

OTHER

Pediatric subjects aged 12-15 years

Device: Acoustic Resonance (Sound) Therapy

Ages 16-21

OTHER

Pediatric subjects aged 16-21 years

Device: Acoustic Resonance (Sound) Therapy

Interventions

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

Ages 12-15; Ages 16-21

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Wave Therapeutics: lead

Study Sites (1)

Crescendo MD

Portola Valley, California, 94028, United States

Location

Related Publications (1)

• 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.

  PMID: 37812532 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction; Inflammation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan Greene, MD

  Crescendo MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: January 9, 2025
• Primary Completion: March 16, 2025
• Study Completion: March 30, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)