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

NCT06024564 | Terminated FDA Device

• 1 other identifier: CP-007
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Congestion

Outcome Measures

Primary Outcomes (2)

• Weekly Utilization-Frequency

  Weekly utilization of Sonu treatment, measured as the frequency or number of times used per week

  90 days

• Weekly Utilization-Duration

  Weekly utilization of Sonu treatment, measured as the duration of treatment received per week

  90 days

Secondary Outcomes (2)

• Total Nasal Symptom Score (TNSS)

  90 days

• Asthma Control

  90 days

Study Arms (1)

Interventional

EXPERIMENTAL

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

Device: Sonu Acoustic Resonance Therapy

Interventions

Sonu Acoustic Resonance Therapy DEVICE

Participants will receive Sonu treatment twice a day for 90 days

Interventional

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 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

You may not qualify if:

• Head, nasal or sinus surgery within 3 months
• Pregnancy

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

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Jacob Johnson, MD

  San Francisco Otolaryngology Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 6, 2023
• Study Start: August 8, 2023
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)