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SCORE: Sonu Nasal Congestion Relief Study

Sponsor
Third Wave Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05821842
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
18.3
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Sonu
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
double blinded
Primary Purpose:
Treatment
Official Title:
Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion
Actual Study Start Date :
Mar 23, 2022
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Primary Effectiveness [2 weeks]

    Statistically significant improvement in nasal congestion subscore compared to baseline congestion score

Secondary Outcome Measures

  1. Secondary Effectiveness [2 weeks]

    Statistically significant improvement in total nasal symptom score (TNSS) compared to baseline TNSS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Francisco Otolaryngology Medical Group San Francisco California United States 94108

Sponsors and Collaborators

  • Third Wave Therapeutics

Investigators

  • Principal Investigator: Jacob Johnson, MD, San Francisco Otolaryngology Medical Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Third Wave Therapeutics
ClinicalTrials.gov Identifier:
NCT05821842
Other Study ID Numbers:
  • CP-002
First Posted:
Apr 20, 2023
Last Update Posted:
Apr 20, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Inflammation

Study Results

No Results Posted as of Apr 20, 2023