Acoustic resonance therapy is safe and effective for the treatment of nasal congestion in rhinitis: A randomized sham-controlled trial

Abstract

Background: Acoustic resonance therapy (ART) is a novel vibrational treatment that delivers patient-specific resonant frequency acoustic energy to the sinonasal cavities. In a pilot study, ART was effective for the acute treatment of nasal congestion. We conducted a sham-controlled randomized trial to validate the efficacy of ART when administered daily for 2 weeks. Methods: A total of 52 adult patients were enrolled in a multi-center, randomized, double-blinded, sham-controlled, interventional study evaluating ART administered by a vibrational headband. Patients received either active treatment or a non-therapeutic sham treatment twice daily over 2 weeks. Clinical endpoints were the average change in nasal congestion sub-score of the Total Nasal Symptom Score (TNSS) and the average change in composite TNSS. Results: ART resulted in a significantly greater mean change in the nasal congestion sub-score compared to sham (−0.87 [95% confidence interval [CI] −1.11, −0.62] vs. −0.44 [95% CI −0.64, −0.23], p = 0.008). ART also resulted in a significantly greater reduction in the composite TNSS versus sham, (−2.85 [95% CI −3.85, −1.85], vs. −1.32 [95% CI −2.27, −0.36], p = 0.027). The response rate, determined by a nasal congestion sub-score minimal clinically important difference of 0.23, was 80.8% for ART and 46.2% for sham, with an adjusted risk ratio of 1.95 (95% CI 1.26, 3.02, p = 0.003) in favor of ART. Safety endpoints showed no adverse events. Conclusion: ART is a safe and effective non-pharmacologic alternative for the treatment of nasal congestion.