Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-09

Study Completion Date

2025-03-30

Brief Summary

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

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Detailed Description

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Conditions

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Nasal Congestion and Inflammations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ages 12-15

Pediatric subjects aged 12-15 years

Group Type OTHER

Acoustic Resonance (Sound) Therapy

Intervention Type 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 16-21

Pediatric subjects aged 16-21 years

Group Type OTHER

Acoustic Resonance (Sound) Therapy

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No