Acoustic Resonance Therapy for Treating Empty Nose Syndrome

NCT ID: NCT07215013

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2028-07-31
• Study Completion Date: 2030-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Personalized ART

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

Group Type: EXPERIMENTAL

Personalized ART

Intervention Type: 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.

Non-personalized ART

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

Group Type: ACTIVE_COMPARATOR

Non-personalized ART

Intervention Type: DEVICE

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

Interventions

Personalized ART

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.

Intervention Type: DEVICE

Non-personalized ART

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

Intervention Type: DEVICE

Other Intervention Names

Sonu

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Neurocognitive diagnosis/decline

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jayakar Nayak

Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jayakar Nayak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Kai Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Stanford University

Stanford, California, United States

Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

JN-ENT-R01

Identifier Type: -

Identifier Source: org_study_id