Back to resultsSonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion (SCORE)
Primary Purpose
Nasal Congestion and Inflammations
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonu
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Congestion and Inflammations
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
Sites / Locations
- San Francisco Otolaryngology Medical Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Sonu Treatment Group
Sham Control Group
Arm Description
Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu.
Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu.
Outcomes
Primary Outcome Measures
Primary Effectiveness
Statistically significant improvement in nasal congestion subscore compared to baseline congestion score
Secondary Outcome Measures
Secondary Effectiveness
Statistically significant improvement in total nasal symptom score (TNSS) compared to baseline TNSS
Full Information
NCT ID
NCT05821842
First Posted
April 7, 2023
Last Updated
September 19, 2023
Sponsor
Third Wave Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT05821842
Brief Title
Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion
Acronym
SCORE
Official Title
Sonu Nasal COngestion RElief Study (SCORE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Third Wave Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Congestion and Inflammations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blinded
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sonu Treatment Group
Arm Type
Experimental
Arm Description
Patients will receive acoustic resonance therapy for 15 minutes, twice a day, for two weeks using Sonu.
Arm Title
Sham Control Group
Arm Type
Sham Comparator
Arm Description
Patients will receive non-resonant acoustic energy for 15 minutes, twice a day, for two weeks using Sonu.
Intervention Type
Device
Intervention Name(s)
Sonu
Intervention Description
Acoustic energy delivery
Primary Outcome Measure Information:
Title
Primary Effectiveness
Description
Statistically significant improvement in nasal congestion subscore compared to baseline congestion score
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Secondary Effectiveness
Description
Statistically significant improvement in total nasal symptom score (TNSS) compared to baseline TNSS
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Johnson, MD
Organizational Affiliation
San Francisco Otolaryngology Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Otolaryngology Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion
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