Acoustic Resonance Therapy for Treating Empty Nose Syndrome

N/ANot Yet RecruitingNCT07215013

Stanford University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Empty Nose Syndrome Nasal Obstruction

Interventions

ART personalized to the patient's exact cranio-facial dimensions. Once dimensions are calculated, ART frequency is calculated by an algorithm that is then transmitted to a headband worn by the patient three times a day.

Non-personalized ARTDEVICE

ART frequency randomly transmitted to a headband worn by the patient three times a day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented case of Empty Nose Syndrome * Documented past turbinate reduction surgery Exclusion Criteria: * Neurocognitive diagnosis/decline

Locations (2)

Stanford University

Stanford, California, United States

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Change in 6-item ENS-6Q Questionnaire Score

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.

Time frame: Monthly for up to 2 years

Data from ClinicalTrials.gov

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