Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion

NCT ID: NCT06024564

Last Updated: 2025-01-01

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

TERMINATED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-08

Study Completion Date

2024-08-31

Brief Summary

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Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion

Detailed Description

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This is an interventional study designed to gather data on real world utilization of Acoustic Resonance Therapy for treating moderate to severe nasal congestion

Conditions

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Nasal Congestion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional

Participants will receive Acoustic Resonance Therapy using the Sonu headband and App, twice a day, for 90 days

Group Type EXPERIMENTAL

Sonu Acoustic Resonance Therapy

Intervention Type DEVICE

Participants will receive Sonu treatment twice a day for 90 days

Interventions

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Sonu Acoustic Resonance Therapy

Participants will receive Sonu treatment twice a day for 90 days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* Present with symptoms of chronic nasal congestion
* 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
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Wave Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

San Francisco Otolaryngology Medical Group

Locations

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San Francisco Otolaryngology Medical Group

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-007

Identifier Type: -

Identifier Source: org_study_id

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