Acoustic Resonance Therapy for Treating Empty Nose Syndrome

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07215013
Status
Not Yet Recruiting

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Conditions

  • Empty Nose Syndrome
  • Nasal Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Non-personalized ART — DEVICE
    ART frequency randomly transmitted to a headband worn by the patient three times a day.

Study Details

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.

Key Dates

Start date
Jul 31, 2028
Status verified
Oct 2025
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized ART
    Participants receive personalized ART three times a day for 15 minutes over the study duration.
  • Active Comparator: Non-personalized ART
    Participants receive non-personalized ART three times a day for 15 minutes over the study duration.

Primary Outcome Measure

Change in 6-item ENS-6Q Questionnaire Score [ Time Frame: Monthly for up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
Ohio State UniversityColumbusOhio43210-

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