Acoustic Resonance Therapy Safe and Effective for Nasal Congestion in Rhinitis
Key findings
- This randomized, sham-controlled, double-blind two-week trial evaluated the safety and efficacy of an investigational proprietary acoustic resonance therapy (ART) in treating nasal congestion in adults with allergic or non-allergic rhinitis
- Compared with the 26 patients who had sham therapy, the 26 who received ART improved more on the nasal congestion subscore of the Total Nasal Symptom Score (TNSS) (-0.87 vs. -0.44 point; P=0.008) and the overall TNSS (-2.85 vs. -1.32 points; P=0.027)
- Response rates were higher in the ART group than the control group for the nasal congestion subscore (81% vs. 46%; P=0.02) and the overall TNSS (85% vs. 65%; P=0.11)
- No intervention-related severe or non-severe adverse events were noted
- ART may become an option for patients who prefer a nonpharmacologic approach to rhinitis
A recently developed approach to treating nasal decongestion is to apply acoustic energy or vibration to the sinonasal cavities. Acoustic resonance therapy (ART) improves on this by delivering vibrations at the resonant frequency of each patient's sinonasal cavities, which depends on their anatomy.
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An investigational ART headband, Sonu (Sound Health Systems, Los Altos, CA), improved nasal congestion after just two 10-minute sessions in 90% of subjects in a pilot study published in the International Forum of Allergy & Rhinology. Now, a randomized trial has produced further evidence of the safety and effectiveness of ART for nasal congestion.
Benjamin S. Bleier, MD, FACS, director of otolaryngology translational research at Mass Eye and Ear, and colleagues detail the findings in a new paper published in the International Forum of Allergy & Rhinology.
Background on Sonu
Sonu delivers ART through a headband worn around the forehead that houses two bone conduction transducers. The headband has a Bluetooth connection to a smartphone app that uses the smartphone's camera to capture multiple surface anatomic landmarks.
An algorithm calculates the volumes of the maxillary sinus, ethmoid sinus, and nasal cavity (sphenoid and frontal sinuses excluded). It delivers the appropriate resonant frequency for the individual, which falls in the audible range of 100 to 1,000 Hz.
Methods
Conducted at three centers, the two-week trial enrolled 52 subjects (58% female, mean age 47, age range 18–72) who reported having symptoms of moderate to severe nasal congestion for at least one month secondary to allergic or non-allergic rhinitis. At screening they had a 24-hour reflective nasal congestion subscore ≥2 on the Total Nasal Symptoms Score (TNSS).
Participants were randomly assigned 1:1 in a double-blinded fashion to use one of the following for 15 minutes twice daily for two weeks:
- ART—Continual sound transmission of the individually calculated resonant frequency and associated harmonics through the Sonu device
- Sham therapy—A physically identical device delivered a non-resonant acoustic tone (2 kHz) at 50% volume for two seconds, followed by eight seconds of silence; the frequency fell outside the highest resonant range of the treatment group but could still be felt and heard
Each participant received $125.
Primary and Secondary Endpoints
The primary and secondary endpoints were improvement from baseline in the TNSS nasal congestion subscore and the overall TNSS, respectively, averaged over the two weeks of treatment:
- TNSS nasal congestion subscore: −0.87 point with ART vs. −0.44 point with sham therapy (P=0.008)
- Overall TNSS: −2.85 vs. −1.32 points (P=0.027)
The differences remained significant after adjustment for age, gender, and allergic versus nonallergic rhinitis. Moreover, the nasal congestion subscore and the overall score were better in week two of treatment than in week one.
Other Findings
The response rate was defined as the proportion of participants who reported improvement greater than the minimal clinically important difference (MCID) of 0.23 point:
- TNSS nasal congestion subscore: 81% with ART vs. 46% with sham therapy (P=0.02)
- Overall TNSS: 85% vs. 65% (P=0.11)
Even after adjustment for demographics and allergic/non-allergic rhinitis, the probability of achieving or exceeding the MCID was greater with ART than sham therapy:
- TNSS nasal congestion subscore: RR, 1.75; P=0.016
- Overall TNSS: RR, 1.51; P=0.011
No intervention-related severe or non-severe adverse events were noted.
Commentary
The effect size for ART in this study compared favorably with that of intranasal corticosteroid sprays in randomized placebo-controlled trials for allergic rhinitis. ART may be an attractive option for patients with rhinitis who wish to avoid the risk of rhinitis medicamentosa or cardiovascular side effects with decongestants or are bothered by dryness, epistaxis or bad taste with nasal steroids.
The trial was sponsored by Sound Health Systems, which anticipates that future research into ART may include indications such as chronic rhinosinusitis and upper airway resistance syndrome.
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