Acoustic Resonance Therapy for Empty Nose Syndrome

Not yet recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Acoustic Resonance Therapy (ART), which uses sound vibrations, can alleviate symptoms of Empty Nose Syndrome (ENS). ENS often feels like nasal congestion, even when the nose is clear, and ART aims to improve this by using sound to open the nasal passages. Participants will receive either personalized ART or a standard version to determine which is more effective. Individuals diagnosed with ENS who have undergone turbinate reduction surgery may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for ENS.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Acoustic Resonance Therapy is safe for treating nasal conditions?

Research has shown that Acoustic Resonance Therapy (ART) is safe. The FDA has approved ART for treating common nasal blockages, indicating it has passed safety tests for other uses. In one study using ART, participants reported no adverse side effects and experienced significant relief from nasal congestion, suggesting ART is gentle on the body. It works by using sound vibrations to clear nasal blockages and improve breathing. For those considering joining this trial, the safety information appears promising.12345

Why are researchers excited about this trial?

Researchers are excited about Acoustic Resonance Therapy (ART) for Empty Nose Syndrome because it offers a novel approach compared to current treatments like nasal saline irrigations and surgical interventions. Unlike these traditional methods, ART uses sound waves to potentially restore nasal function and sensation. The personalized ART approach tailors the therapy to individual needs, which might enhance effectiveness. This innovative technique provides a non-invasive alternative that could improve quality of life for those affected by this challenging condition.

What evidence suggests that Acoustic Resonance Therapy might be an effective treatment for Empty Nose Syndrome?

Studies have shown that Acoustic Resonance Therapy (ART) can effectively treat nasal congestion. In a small initial study, ART helped with sudden nasal congestion by using sound vibrations to improve airflow. ART sends specific sound frequencies to the nasal passages, breaking up mucus and reducing swelling. For conditions like allergic rhinitis (a type of nasal allergy) and chronic rhinosinusitis (long-term sinus inflammation), ART may increase nitric oxide production, improve mucus movement, and alter immune responses. Although the FDA has approved ART for regular nasal blockage, its potential to treat Empty Nose Syndrome (ENS) remains under investigation. This trial will compare Personalized ART and Non-personalized ART to evaluate their effectiveness in treating ENS.12678

Who Is on the Research Team?

JN

Jayakar Nayak, MD, PhD

Principal Investigator

Stanford University

KZ

Kai Zhao, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for individuals suffering from Empty Nose Syndrome, a condition causing nasal obstruction and congestion. Participants should have symptoms of ENS and be seeking treatment.

Inclusion Criteria

I have been diagnosed with Empty Nose Syndrome.
I have had surgery to reduce the size of my nasal turbinates.

Exclusion Criteria

Neurocognitive diagnosis/decline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either personalized or non-personalized Acoustic Resonance Therapy three times a day for 15 minutes

24 months
Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acoustic Resonance Therapy
Trial Overview The study tests Acoustic Resonance Therapy (ART), an FDA-approved method for standard nasal blockage, to see if it eases Empty Nose Syndrome symptoms by using sound vibrations to clear sinus tissues.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized ARTExperimental Treatment1 Intervention
Group II: Non-personalized ARTActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Acoustic Resonance Therapy for Treating Empty Nose ...ART is a non-invasive treatment that uses sound vibrations to improve nasal congestion and other sinus symptoms. ART works by delivering ...
Acoustic Resonance Therapy for Treating Empty Nose ...This study is to determine whether Acoustic Resonance Therapy (ART), an FDA-approved treatment for standard nasal obstruction, may be helpful in mitigating ...
Acoustic Resonance Therapy for Empty Nose SyndromeThis study is to determine whether Acoustic Resonance Therapy (ART), an FDA-approved treatment for standard nasal obstruction, ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37812532/
Acoustic resonance therapy is safe and effective for the ...In a pilot study, ART was effective for the acute treatment of nasal congestion. We conducted a sham-controlled randomized trial to validate the ...
Acoustic therapy for allergic rhinitis and chronic rhinosinusitisAcoustic therapy shows potential benefits, including enhanced nitric oxide production, improved mucociliary clearance, and modulation of immune responses by ...
DEN230045, Sonu, Sound Health Systems, Inc.• Acoustic resonance therapy (ART) using Sonu was safe with no adverse events reported. • Sonu significantly reduced nasal congestion ...
Jayakar V. Nayak, MD, PhD - Stanford MedicineDr. Nayak is an expert in congenital, acquired and genetic nasal and sinus disorders and in their treatment through medical and surgical alternatives.
FDA-Cleared Device Delivers Acoustic Resonance ...Acoustic resonance therapy is safe and effective for the treatment of nasal congestion in rhinitis: A randomized sham-controlled trial.
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