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Completed

NCT Number: NCT05821842

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

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

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Key information

Conditions

Nasal Congestion and Inflammations Airway Obstruction Inflammation Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Otolaryngology Medical Group

San Francisco, California, 94108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonu

Device

Acoustic energy delivery

Primary outcomes

  1. Primary Effectiveness

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Secondary Effectiveness

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Third Wave Therapeutics

Industry

Registry information

Official study title

Sonu Nasal COngestion RElief Study (SCORE)

Acronym: SCORE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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