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

NCT05821842 | Completed Results FDA Device

• 1 other identifier: CP-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Congestion and Inflammations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Effectiveness

  2 weeks

Study Arms (2)

Sonu Treatment Group

EXPERIMENTAL

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

Device: Sonu

Sham Control Group

SHAM COMPARATOR

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

Device: Sonu

Interventions

Sonu DEVICE

Acoustic energy delivery

Sham Control Group; Sonu Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Wave Therapeutics: lead

Study Sites (1)

San Francisco Otolaryngology Medical Group

San Francisco, California, 94108, United States

Location

MeSH Terms

Conditions

Nasal Obstruction; Inflammation

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paramesh Gopi
• Organization: Sound Health Systems, Inc.

pgopi@soundhealth.life

313-509-8237

Study Officials

• Jacob Johnson, MD

  San Francisco Otolaryngology Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: March 23, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)