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

Nasal Congestion and Inflammations Clinical Trial

— SCORE  

Official title:

Sonu Nasal COngestion RElief Study (SCORE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05821842
• Other study ID #: CP-002
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Third Wave Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Nasal Congestion and Inflammations

Intervention

Device:
• Sonu
Acoustic energy delivery

Locations

Country	Name	City	State
United States	San Francisco Otolaryngology Medical Group	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Third Wave Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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