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

Sonu Nasal COngestion RElief Study (SCORE)

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

Study Overview

• Status: Completed
• Conditions: Nasal Congestion and Inflammations
• Intervention / Treatment: Device: Sonu

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paramesh Gopi, PhD; Phone Number: 313.509.8237; Email: pgopi@soundhealth.life

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94108
      • San Francisco Otolaryngology Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sonu Treatment Group; Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu.	Device: Sonu; Acoustic energy delivery
Sham Comparator: Sham Control Group; Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu.	Device: Sonu; Acoustic energy delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effectiveness	Change in total nasal symptom score (TNSS) compared to baseline. The TNSS is the sum of four (4) symptom sub-scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each self-rated by the subject using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. TNSS scores are reported on a scale of 0-12. 0 is the minimum and 12 is the maximum. Higher scores mean worse outcomes.	2 weeks

Collaborators and Investigators

• Sponsor: Third Wave Therapeutics
• Investigators: Principal Investigator: Jacob Johnson, MD, San Francisco Otolaryngology Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: CP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No