Sonu Nasal COngestion RElief Study (SCORE)

Third Wave Therapeutics1 site in 1 country52 target enrollmentMarch 23, 2022

ConditionsNasal Congestion and Inflammations

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nasal Congestion and Inflammations
Sponsor: Third Wave Therapeutics
Enrollment: 52
Locations: 1
Primary Endpoint: Primary Effectiveness
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

March 23, 2022

End Date

June 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Third Wave Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Primary Effectiveness

Time Frame: 2 weeks

Change in nasal congestion sub-score compared to baseline. The nasal congestion sub-score is reported on a scale of 0-3. 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes.