Clinical Evidence

Peer-reviewed
proof. Measured
in minutes.

Acoustic Resonance Therapy is the only nasal-congestion therapy whose efficacy has been demonstrated against a sham control in a multi-center, randomized, double-blinded trial — and the only one to start working in 15 minutes.

SONU PIVOTAL TRIAL

Trial design at a glance.

A rigorous multi-center, randomized, double-blinded, sham-controlled, interventional study evaluating Acoustic Resonance Therapy delivered via a vibrational headband.

PATIENTS

n = 52

Adults enrolled across multiple sites with moderate-to-severe nasal congestion

DESIGN

Randomized,
double-blinded,
sham-controlled

Active ART vs. non-therapeutic sham device — neither patient nor investigator unblinded during data collection

PROTOCOL

Twice daily
over 2 weeks

Two 15-minute sessions per day at home, with daily symptom diary

PRIMARY ENDPOINT

Change in
TNSS

Mean change from baseline in the nasal congestion sub-score of the Total Nasal Symptom Score

SECONDARY ENDPOINT

Composite TNSS

Aggregated symptom score across congestion, rhinorrhea, itch, and sneezing

INDICATION

Allergic &
non-allergic rhinitis

FDA-cleared for patients 12 years and older

Why it matters clinically

Most over-the-counter and prescription nasal congestion therapies are studied as open-label comparisons or against active controls. SONU was tested against a non-therapeutic sham with full blinding — the highest bar for demonstrating that benefit comes from the therapy itself, not placebo response or expectation.

The result: a statistically significant improvement in nasal congestion and total nasal symptoms within the 2-week protocol — and meaningful symptom relief beginning within 15 minutes of the first session.

Greater TNSS
improvement than sham.

Mean change in Total Nasal Symptom Score from baseline favored Acoustic Resonance Therapy across both Week 1 and Week 2 evaluations — with separation from sham widening over time as patients accumulated treatment exposure.

Mean change in TNSS from baseline

Higher bar = greater symptom reduction
Error bars depict standard error.
TNSS Graph White
Illustrative representation. See published
manuscript for exact values and statistical analysis.

Greater TNSS
improvement than sham.

Mean change in Total Nasal Symptom Score from baseline favored Acoustic Resonance Therapy across both Week 1 and Week 2 evaluations — with separation from sham widening over time as patients accumulated treatment exposure.

Mean change in TNSS from baseline

Higher bar = greater symptom reduction
Error bars depict standard error.
TNSS Graph Grey
Illustrative representation. See published
manuscript for exact values and statistical analysis.
SYMPTOM-LEVEL RELIEF

Clinically proven across
the full TNSS profile.

SONU has been clinically shown to relieve the four symptoms that define both allergic and non-allergic rhinitis in adults and adolescents 12+.

Stuffy nose
Stuffy nose
Runny nose
Runny nose
Itchy nose
Itchy nose
Sneezing
Sneezing

For adults and children 12 years and older, SONU can be used twice daily for 5–15 minutes per session. Additional sessions as needed are clinically safe.

FROM THE PRINCIPAL INVESTIGATOR

KOL perspective on the
SONU study.

Watch Video

"Patients want something they can do at home, drug-free, that actually works. The trial demonstrated meaningful TNSS improvement against a sham control — that's the bar we need in this space."

Principal Investigator
Stanford Sinus Center — Otolaryngology
SONU VS. INTRANASAL STEROID SPRAYS

A new option — not just
a faster one.

For patients who can’t tolerate, don’t respond to, or want to avoid chronic intranasal steroid use, SONU offers a clinically validated, drug-free alternative or adjunct.

SONU Band

Begins working in 15 minutes; twice-daily 15-min sessions
No growth-suppression labeling concerns — FDA-cleared 12+
No systemic side effects observed in pivotal trial
Drug-free, steroid-free — non-pharmacologic mechanism
On-demand acute use plus durable benefit over 2-week protocol

Intranasal Steroids

Hours to days to begin working; up to 14 days to peak efficacy
Pharmacologic mechanism with systemic exposure
Pediatric labeling warnings around growth suppression with chronic use
Common side effects: epistaxis, nasal dryness, mucosal irritation
Daily adherence required to maintain control
1 / 2
Patient experience

Three simple
steps to relief.

A one-time AI-driven facial scan calibrates the SONU device to the patient's unique sinus and airway anatomy — no two protocols are identical.

Patients wear SONU for 15 minutes, twice daily. Acoustic resonance vibration mobilizes congested mucus and reduces inflammation in the sinonasal cavities.

Adherence and patient-reported outcomes flow to the clinician portal — so you can identify non-responders or escalate care between visits.

Patient experience

Three simple steps to relief.

Personalize

A one-time AI-driven facial scan calibrates the SONU device to the patient's unique sinus and airway anatomy — no two protocols are identical.

Treat

Patients wear SONU for 15 minutes, twice daily. Acoustic resonance vibration mobilizes congested mucus and reduces inflammation in the sinonasal cavities.

Monitor

Adherence and patient-reported outcomes flow to the clinician portal — so you can identify non-responders or escalate care between visits.

Patient Experience Sleep Quality
60 %
Mean reduction in Insomnia Severity Index (ISI)
> 90 %
Of participants reported improved sleep quality

Drug-Free

Non-pharmacologic, non-habit-forming therapy

Stanford

Clinical evaluation led by Stanford Sleep Medicine
Patient experience

For insomnia: Stanford-validated sleep quality outcomes.

The Spatial Sleep wellness headband uses the same Acoustic Resonance Therapy platform, customized for sleep. Clinical evaluation led by Stanford Sleep Medicine demonstrated significant, durable improvements in patient-reported sleep quality and insomnia severity.


Useful as an adjunct to CPAP, behavioural therapy for insomnia, and dental airway treatment — or as a first-line, drug-free option for patients reluctant to start sedative-hypnotics.

Want the full
evidence package?

Our clinical team can share peer-reviewed manuscripts, conference posters, FDA documentation, and ongoing real-world evidence with credentialed clinicians, formulary committees, and researchers.

  1. SONU pivotal trial: multi-center, randomized, double-blinded, sham-controlled study (n=52), evaluating Acoustic Resonance Therapy administered by a vibrational headband twice daily for 2 weeks. Primary endpoint: mean change from baseline in the TNSS nasal congestion sub-score.
  2. Chart figures shown are illustrative reconstructions of the published trial's directional results. Refer to peer-reviewed manuscript and FDA 510(k) summary for exact values and statistical significance.
  3. Onset claim ("begins working in 15 minutes") refers to patient-reported acute symptom relief observed during and immediately following a single therapeutic session. Long-term benefit accrues with the 2-week twice-daily protocol.
  4. Spatial Sleep clinical outcomes from Stanford-led wellness evaluation. Spatial Sleep is a wellness device and is not intended to diagnose, treat, cure, or prevent any disease.
  5. SONU is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis in patients 12 years and older. Individual results may vary.