Acoustic Resonance Therapy for Treating Empty Nose Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized ART, Non-personalized ART.
- Who it may be relevant to
- Registry conditions: Empty Nose Syndrome, Nasal Obstruction. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acoustic Resonance Therapy for Treatment of Empty Nose Syndrome: A Prospective, Phase 2 Randomized Clinical Trial
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.
Interventions
- Device Personalized ART
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. - Device Non-personalized ART
ART frequency randomly transmitted to a headband worn by the patient three times a day.
Primary outcome measures
- Change in 6-item ENS-6Q Questionnaire Score [Time frame: Monthly for up to 2 years]
Eligibility criteria
Inclusion criteria
- Documented case of Empty Nose Syndrome
- Documented past turbinate reduction surgery
Exclusion criteria
- Neurocognitive diagnosis/decline
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Stanford University — Stanford
- Ohio State University — Columbus
Identifiers
NCT: NCT07215013 · JN-ENT-R01