Acoustic Resonance Therapy for Treating Empty Nose Syndrome

NCT07215013 | Not Yet Recruiting FDA Device

• 1 other identifier: JN-ENT-R01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to determine whether Acoustic Resonance Therapy (ART), an FDA-approved treatment for standard nasal obstruction, may be helpful in mitigating the debilitating symptoms of Empty Nose Syndrome (ENS), which includes an alternative form of nasal obstruction. ART is a non-invasive treatment that uses sound vibrations to improve nasal congestion and other sinus symptoms. ART works by delivering specific frequencies of sound to the sinonasal cavities (nose and sinuses). These vibrations cause the tissues in the sinuses to resonate, which can help break up mucus and clear blockages, reduce inflammation, and improve airflow.

Conditions

Empty Nose Syndrome; Nasal Obstruction

Outcome Measures

Primary Outcomes (1)

• Change in 6-item ENS-6Q Questionnaire Score

  The ENS6Q refers to the 6-Item Nasal Symptom Questionnaire, which is a tool used to assess nasal symptoms in patients, particularly in the context of conditions like allergic rhinitis, chronic rhinosinusitis, or other nasal disorders. This questionnaire helps clinicians evaluate the severity and impact of nasal symptoms on a patient's quality of life. Each item on the questionnaire is typically rated on a scale (e.g., 0 to 3 or 0 to 4). The total score (range: 0 to 30) is calculated by summing the scores from each item, providing an overall assessment of nasal symptom severity. For both item and total scores, higher scores indicate more severe symptoms. A reduction of 7 points from baseline is considered clinically significant reduction in symptoms.

  Monthly for up to 2 years

Study Arms (2)

Personalized ART

EXPERIMENTAL

Participants receive personalized ART three times a day for 15 minutes over the study duration.

Device: Personalized ART

Non-personalized ART

ACTIVE COMPARATOR

Participants receive non-personalized ART three times a day for 15 minutes over the study duration.

Device: Non-personalized ART

Interventions

Personalized ART DEVICE

ART personalized to the patient's exact cranio-facial dimensions. Once dimensions are calculated, ART frequency is calculated by an algorithm that is then transmitted to a headband worn by the patient three times a day.

Also known as: Sonu

Personalized ART

Non-personalized ART DEVICE

ART frequency randomly transmitted to a headband worn by the patient three times a day.

Non-personalized ART

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented case of Empty Nose Syndrome
• Documented past turbinate reduction surgery

You may not qualify if:

• Neurocognitive diagnosis/decline

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Jayakar Nayak, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Kai Zhao, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 10, 2025
• Study Start (Estimated): July 1, 2028
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)