Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Allergic Rhinitis

Summary

Allergic rhinitis (AR) is a common condition, with nearly 300 million affected individuals in China, significantly impacting the quality of life. Despite standardized drug treatments, approximately 20% of AR patients experience inadequate control and require surgical intervention. AR manifests as nasal itching, sneezing, clear nasal discharge, nasal congestion, primarily associated with inflammation-induced hypertrophy of nasal turbinates and a heightened neurogenic state of the nasal mucosa. Surgical treatment focuses on "reducing hypertrophy" of nasal turbinates and "desensitizing" neurogenic hyperreactivity.High-intensity focused ultrasound (HIFU), as a minimally invasive therapeutic modality in AR, is still in its early stages of application and requires further multicenter clinical studies and widespread adoption. This project collaborates with six established institutions proficient in ultrasound treatment for AR. It aims to conduct a prospective multicenter observational study and subsequent dissemination, emphasizing the application of "reduction of hypertrophy" and "desensitization" in AR.Through standardized case selection, subjective and objective measures such as subjective symptom scores, quality of life assessments, nasal reflex, and nasal resistance tests before and after treatment will be employed to evaluate the effectiveness and safety of HIFU in "reducing hypertrophy" and "desensitizing" aspects of AR. Simultaneously, building on our established Otolaryngology Head and Neck Surgery Alliance and Southwest Allergy Alliance, the research results will be promoted through lectures, hands-on guidance, training sessions, academic conferences, and other means to facilitate the application of HIFU in AR and benefit a larger population of AR patients.

Conditions

• Allergic Rhinitis

Interventions

PROCEDURE

High-intensity focused ultrasound (HIFU)

Ultrasound is a type of mechanical vibrational wave capable of penetrating living tissues without causing harm to the tissue. As a non-invasive physical modality, ultrasound boasts advantages such as non-invasive safety, excellent directional propagation, strong penetration capability, and optimal focusing effects. It can induce a series of structural and functional changes in tissue cells through actions like cavitation, mechanical force vibration, and heat generation, leading to corresponding clinical effects. Clinical studies have demonstrated that focused ultrasound not only improves symptoms of allergic rhinitis (AR) but also holds certain advantages in preserving the structural and functional integrity of the nasal mucosa.

DRUG

intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines

intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines and other therapies.

Sponsors & Collaborators

• Chongqing Medical University

  lead OTHER

Principal Investigators

• Shen Yang, Doctoral · Chongqing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2025-07-31

Completion

2025-07-31

Countries

• China

Study Locations