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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized ART | Experimental | Participants receive personalized ART three times a day for 15 minutes over the study duration. |
|
| Non-personalized ART | Active Comparator | Participants receive non-personalized ART three times a day for 15 minutes over the study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized ART | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Monthly for up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayakar Nayak, MD, PhD | Stanford University | Principal Investigator |
| Kai Zhao, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Ohio State University |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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|
| Non-personalized ART | Device | ART frequency randomly transmitted to a headband worn by the patient three times a day. |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |