Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2023-06-30

Brief Summary

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

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Detailed Description

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Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.

Conditions

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Nasal Congestion and Inflammations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blinded

Study Groups

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Sonu Treatment Group

Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu.

Group Type EXPERIMENTAL

Sonu

Intervention Type DEVICE

Acoustic energy delivery

Sham Control Group

Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu.

Group Type SHAM_COMPARATOR

Sonu

Intervention Type DEVICE

Acoustic energy delivery

Interventions

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Sonu

Acoustic energy delivery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No