Abstract
Acoustic resonance therapy (ART), in which individually calibrated acoustic vibratory energy is delivered to the sinonasal cavities, has been shown to be safe and efficacious to reduce symptoms in adults with allergic and/or nonallergic rhinitis. This prospective, nonrandomized, single‐center feasibility study evaluated potential use in pediatric patients age 12 to 21 with a nasal congestion sub‐score of ≥2 out of 3 on the Total Nasal Symptom Score (TNSS). Nasal congestion sub‐score at baseline was compared with an average of the daily score obtained over 2 weeks on treatment. 31 subjects enrolled. Nasal congestion sub‐score changed by −0.76 (95% CI [−0.97, −0.54], P < .0001) for an average reduction of 35.2%, while aggregate TNSS changed by −2.74 (95% CI [−3.41, −2.06], P < .0001) for an average reduction of 40.5%. All other TNSS subcomponents demonstrated statistically significant improvements compared with their respective baseline. ART warrants further investigation as a nonpharmacologic option for treatment of pediatric chronic rhinitis.
Keywords: nonpharmacologic, pediatric, quality of life, rhinitis, therapeutics, total nasal symptom score, vibration
Nasal congestion associated with chronic rhinitis is present in up to 40% of children, often with detriment to quality of life. 1 While medicated nasal sprays offer some relief, the efficacy of pharmacotherapy can be limited by non‐adherence as well as drug side effects. 2
Acoustic resonance therapy (ART) is a novel treatment in which individually calibrated acoustic vibratory energy is delivered to the sinonasal cavities. The Sonu band (SoundHealth) is an FDA‐cleared over‐the‐counter ART device demonstrated to reduce nasal congestion and rhinitis symptoms in adults over age 22. 3 , 4 This feasibility study evaluates potential use in children over age 12.
Methods
Design
This was a prospective, nonrandomized, single‐center study of patients aged 12 to 21, subdivided into age 12 to 15 (Group A) and 16 to 21 (Group B). Patients were recruited if suffering from moderate‐to‐severe nasal congestion for >1 month, defined as ≥2 out of 3 on the nasal congestion subdomain of the Total Nasal Symptom Score (TNSS). This instrument has been used in studies of rhinitis in pediatric patients. 5 Parental consent was obtained for patients <18. Subjects were excluded if they had undergone sinonasal surgery in the prior 3 months or suffered from a recent sinus infection, rhinitis medicamentosa, nasal polyps, or nasal mass. The study was approved by the Western Institutional Review Board.
Intervention
Participants were provided the Sonu device and accompanying smartphone app, which uses the self‐facing camera to measure facial landmarks. A machine‐learning model, based on CT scan‐derived algorithms, uses these landmarks to estimate sinonasal volume and determine the resonant frequency of the sinonasal cavities, creating a sound file to play through bone conduction transducers via a headband. 6
Intervention consisted of 15‐minute ART treatments twice daily during predefined treatment windows for 2 weeks.
Subjects were instructed to continue regularly taken medications and discontinue as‐needed medications.
Subjects were compensated $100 for their time in the study.
Evaluation
Subjects reported their baseline TNSS at enrollment and a daily 24‐hour reflective TNSS upon completion of the first treatment of each day. Adverse events were reported.
Endpoints and Data Analysis
The primary outcome was change in nasal congestion sub‐score of TNSS (maximum 3 points) between baseline score and daily score averaged over 2 weeks on therapy. Power calculation was based on a prior adult study, which found a change of −0.87 from baseline to 2‐week follow‐up. 4 To detect a mean paired difference of −0.87 with 80% power, significance 0.05, and attrition rate 10%, 8 subjects in each age group were required. To achieve greater statistical power, at least 15 patients were enrolled per group. The secondary outcome was change in aggregate TNSS (maximum 12 points).
Shapiro‐Wilk test confirmed normal distribution. Paired t‐test was used to compare continuous outcome variables from baseline to 2‐week follow‐up.
Results
31 subjects enrolled from January to March 2025, with 15 in Group A and 16 in Group B; see Table 1 for demographics. 6 patients continued existing allergy medications.
Table 1.
Demographics
| Group A 12‐15 years | Group B 16‐21 years | Combined 12‐21 years | |
|---|---|---|---|
| Sex | |||
| Male (%) | 10 (66.7%) | 7 (43.7%) | 17 (54.8%) |
| Female (%) | 5 (33.3%) | 9 (56.3%) | 14 (45.2%) |
| Age | |||
| Mean ± SD | 13.47 ± 0.83 | 17.88 ± 1.45 | 15.74 ± 2.53 |
| Baseline nasal congestion sub‐score | |||
| Mean ± SD | 2.20 ± 0.41 | 2.13 ± 0.34 | 2.16 ± 0.37 |
| Baseline aggregate TNSS | |||
| Mean ± SD | 6.60 ± 2.50 | 6.94 ± 1.57 | 6.77 ± 2.04 |
| Baseline medication usea | |||
| Yes | 3 | 3 | 6 |
| No | 12 | 13 | 25 |
| Prior sinonasal surgery | |||
| Yes | 0 | 0 | 0 |
| No | 15 | 16 | 31 |
Abbreviations: SD, standard deviation; TNSS, total nasal symptom score.
Of the 6 total patients on baseline medical therapy, 2 were on loratadine monotherapy, 2 on cetirizine monotherapy, 1 on BEG nasal spray, and 1 on a combination of loratadine, cetirizine, and fluticasone.
Nasal congestion subscore for Group A changed by −0.70% or −31.8% (95% CI [−44.3%, −19.3%, P < .0001) from a baseline of 2.20 to 1.50 while on therapy (Table 2). In Group B, nasal congestion changed by −0.81 or 38.0% (95% CI [−52.8%, −23.3%], P = .0002) from a baseline of 2.13 to 1.32. Overall change across both groups was −0.76 or −35.2% (95% CI [−44.3%, −26.1%], P < .0001). 29 of 31 subjects (93.5%) reported improvement.
Table 2.
Outcomes
| Baseline mean (SE) | Follow‐up mean (SE) | Difference mean (95% CI) | P‐value | |
|---|---|---|---|---|
| Nasal congestion | ||||
| Group A | 2.20 (0.11) | 1.50 (0.13) | −0.70 [−0.99, −0.41] | <.0001 |
| Group B | 2.13 (0.09) | 1.32 (0.12) | −0.81 [−1.15, −0.46] | .0002 |
| Combined | 2.16 (0.07) | 1.40 (0.09) | −0.76 [−0.97, −0.54] | <.0001 |
| Sneezing | ||||
| Group A | 1.47 (0.22) | 0.86 (0.16) | −0.61 [−0.94, −0.27] | .0016 |
| Group B | 1.25 (0.19) | 0.67 (0.13) | −0.58 [−0.98, −0.17] | .008 |
| Combined | 1.35 (0.14) | 0.76 (0.10) | −0.59 [−0.84, −0.34] | <.0001 |
| Nasal itching | ||||
| Group A | 1.40 (0.25) | 0.81 (0.16) | −0.59 [−1.02, −0.16] | .011 |
| Group B | 1.44 (0.20) | 0.73 (0.13) | −0.70 [−1.07, −0.33] | .001 |
| Combined | 1.42 (0.16) | 0.77 (0.10) | −0.65 [−0.91, −0.38] | <.0001 |
| Rhinorrhea | ||||
| Group A | 1.53 (0.24) | 1.01 (0.17) | −0.52 [−0.80, −0.24] | .001 |
| Group B | 2.13 (0.13) | 1.19 (0.11) | −0.94 [−1.33, −0.55] | .0001 |
| Combined | 1.84 (0.14) | 1.10 (0.10) | −0.74 [−0.98, −0.50] | <.0001 |
| Aggregate TNSS | ||||
| Group A | 6.60 (0.65) | 4.18 (0.51) | −2.42 [−3.39, −1.46] | <.0001 |
| Group B | 6.94 (0.39) | 3.91 (0.36) | −3.03 [−4.05, −2.00] | <.0001 |
| Combined | 6.77 (0.37) | 4.04 (0.30) | −2.74 [−3.41, −2.06] | <.0001 |
Group A: 12 to 15 years; Group B: 16 to 21 years; Combined: 12 to 21 years. Shaded region highlights primary outcome.
Abbreviations: CI, confidence interval; SE, standard error; TNSS, total nasal symptom score.
Aggregate TNSS for Group A changed by −2.42% or −36.7% (95% CI −50.0%, −23.3%], P < .0001) from 6.60 to 4.18 (Table 2). In Group B, TNSS changed by −3.03% or −43.7% (95% CI [−57.2%, −30.1%], P < .0001), from 6.94 to 3.91. Overall change across both groups was −2.74% or −40.5% (95% CI [−50.0%, −30.9%], P < .0001). 30 of 31 subjects (96.8%) reported improvement.
Post‐hoc analysis of other TNSS sub‐components (each measured 0‐3) showed similar improvement (Table 2). In the combined group, sneezing changed by −0.59% or −43.7% (95% CI [61.1%, −26.3%], P < .0001), nasal itching by −0.65% or −45.8% [95% CI [−63.7%, −27.8%], P < .0001), and rhinorrhea by −0.74% or −40.2% [95% CI −53.0%, −27.4%], P < .0001).
The difference in TNSS improvement between pre‐existing medication users and nonusers was 0.09 (P = .75).
There were no adverse events. Adherence to intervention across all subjects was 85.9% with 373 of a total possible 434 treatments completed.
Discussion
Prior literature has linked vibration to several therapeutic effects with regards to sinonasal health, including vasoconstrictive decongestion of the sinonasal mucosa, stimulation of mucociliary clearance, and decreased mucus viscosity. 7 , 8 Vibration may promote neuromodulatory effects, sympathetic tone, and exhaled nitric oxide. 9 A double‐blind, sham‐controlled randomized trial in adults revealed a reduction in TNSS by 38.3% using ART compared with 20.8% using sham. 4
This study explores feasibility of ART in patients aged 12 to 21, for whom nonpharmacologic options may be particularly desirable. The magnitude of improvement was comparable to that seen in adults and to the effect size of intranasal corticosteroids in randomized placebo‐controlled trials. 10 Given that the minimal clinically important difference of the TNSS is 0.28, the change in aggregate TNSS of −2.74 could be clinically meaningful if confirmed in future studies. 11
This feasibility study is limited by its nonrandomized unblinded design and lack of a control arm. Further investigation using a sham‐controlled trial design is warranted to evaluate efficacy in the pediatric population, and a real‐world study may assess other factors such as long‐term outcomes, adherence to longer‐term use, differences based on rhinitis subtype, and the impact of anatomic factors such as adenoid hypertrophy, septal deviation, and prior sinus surgery.
Author Contributions
Ashoke R. Khanwalkar: conceptualization, methodology, manuscript drafting, manuscript editing, manuscript approval; Alan Greene: patient recruitment, manuscript approval; Yifei Ma: data analysis, manuscript approval; Paramesh Gopi: conceptualization, methodology, manuscript approval; Vivek Mohan: methodology, data analysis, manuscript approval; Bryant Lin: conceptualization, methodology, manuscript approval; Peter Hwang: conceptualization, methodology, manuscript editing, manuscript approval.
Disclosures
Accepted and presented as a Late‐Breaking Science abstract to AAO‐HNSF 2025 Annual Meeting.
Competing interests
PHH, BL, PG, and VM have an equity stake in SoundHealth. ARK is on the scientific advisory board for SoundHealth. No other authors have relevant financial or personal conflicts of interest.
Funding source
The study was funded by SoundHealth.
This article was presented at the AAO‐HNSF 2025 Annual Meeting & OTO EXPO; October 11‐14, Indianapolis, Indiana.
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