Acoustic Resonance Therapy for Treating Empty Nose Syndrome

Not Applicable

Not yet recruiting

• Conditions: Empty Nose Syndrome; Nasal Obstruction

• Registration Number: NCT07215013
• Lead Sponsor: Stanford University

Brief Summary

This study is to determine whether Acoustic Resonance Therapy (ART), an FDA-approved treatment for standard nasal obstruction, may be helpful in mitigating the debilitating symptoms of Empty Nose Syndrome (ENS), which includes an alternative form of nasal obstruction. ART is a non-invasive treatment that uses sound vibrations to improve nasal congestion and other sinus symptoms. ART works by delivering specific frequencies of sound to the sinonasal cavities (nose and sinuses). These vibrations cause the tissues in the sinuses to resonate, which can help break up mucus and clear blockages, reduce inflammation, and improve airflow.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-03
• Study First Submitted QC: 2025-10-03
• Last Update Submitted: 2025-10-03
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Study Start: 2028-07-01
• Primary Completion: 2030-07
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Documented case of Empty Nose Syndrome
• Documented past turbinate reduction surgery

Exclusion Criteria

• Neurocognitive diagnosis/decline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in 6-item ENS-6Q Questionnaire Score	Monthly for up to 2 years	The ENS6Q refers to the 6-Item Nasal Symptom Questionnaire, which is a tool used to assess nasal symptoms in patients, particularly in the context of conditions like allergic rhinitis, chronic rhinosinusitis, or other nasal disorders. This questionnaire helps clinicians evaluate the severity and impact of nasal symptoms on a patient's quality of life. Each item on the questionnaire is typically rated on a scale (e.g., 0 to 3 or 0 to 4). The total score (range: 0 to 30) is calculated by summing the scores from each item, providing an overall assessment of nasal symptom severity. For both item and total scores, higher scores indicate more severe symptoms. A reduction of 7 points from baseline is considered clinically significant reduction in symptoms.

Trial Locations

Locations (2)

Stanford University; 🇺🇸 Stanford, California, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States