Acoustic Resonance Therapy for Treating Empty Nose Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented case of Empty Nose Syndrome
Documented past turbinate reduction surgery
Disqualifiers
Neurocognitive diagnosis/decline
Trial design
Design model
Parallel
Treatments tested in this trial
Personalized ART
DeviceART 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 ART
DeviceART frequency randomly transmitted to a headband worn by the patient three times a day.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Personalized ARTExperimental treatment 1 intervention
Group B: Non-personalized ARTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSponsors and contacts
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Stanford University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: