Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

Third Wave Therapeutics

Status: Completed

Conditions: Nasal Congestion and Inflammations

Treatments: Device: Acoustic Resonance (Sound) Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06773013

CP-008

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Ages 12-15

Other group

Description:

Pediatric subjects aged 12-15 years

Treatment:

Device: Acoustic Resonance (Sound) Therapy

Ages 16-21

Other group

Description:

Pediatric subjects aged 16-21 years

Treatment:

Device: Acoustic Resonance (Sound) Therapy