Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases

Summary

The goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for improving autonomic function and sleep quality in perioperative cardiovascular disease patients.

The main questions it aims to answer are:

1. Does LIFU improve heart rate variability and sleep characteristics from baseline at 3-7 days post-surgery compared to sham ultrasound?
2. Does LIFU improve serological markers, vital signs, Pittsburgh Sleep Quality Index (PSQI), and reduce \>30-second perioperative arrhythmias?
3. What is the safety profile of LIFU in this population? 200 eligible patients will be randomized 1:1 to receive either active LIFU (2.0W, 1MHz, 50% duty cycle, 30min daily for 3-7 days) plus standard care, or identical sham ultrasound plus standard care. A four-party double-blind design (subjects, operators, assessors, analysts) will be implemented. The study will run from May 1, 2026 to April 1, 2027 at 6 centers in China.

Participants will:

1. Complete pre-surgery screening and baseline assessments (PSQI, 12h ECG/sleep monitoring, residual blood sample collection)
2. Receive daily assigned ultrasound intervention for 3-7 consecutive days post-surgery
3. Undergo 72h continuous ECG monitoring post-surgery, and repeat assessments at 3-7 days
4. Have all adverse events and arrhythmias recorded throughout the study
5. May withdraw voluntarily at any time without affecting routine medical care

Conditions

• Diagnosed With Cardiovascular Diseases and Scheduled to Undergo Interventional Cardiology Procedures

Interventions

DEVICE

Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion

The experimental group receives active low-intensity focused ultrasound (LIFU) treatment: the ultrasound probe is placed on the skin surface corresponding to the left stellate ganglion and fixed with a mechanical arm, with parameters set as power 2.0W, frequency 1MHz, duty cycle 50%, 30 minutes per session, once daily for 3-7 consecutive days. All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period.

DEVICE

Sham low-intensity focused ultrasound targeting the left stellate ganglion

The control group receives sham low-intensity focused ultrasound intervention: the ultrasound probe is placed on the skin surface corresponding to the left stellate ganglion and fixed with a mechanical arm, with the same instrument appearance, operation process, parameter setting display (power 2.0W, frequency 1MHz, duty cycle 50%), duration (30 minutes per session, once daily for 3-7 consecutive days) and subject experience as the experimental group, but no actual ultrasound energy is output. All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period.

Sponsors & Collaborators

• Yichang Central People's Hospital

  collaborator OTHER

• Wuhan Central Hospital

  collaborator OTHER

• Huangshi Central Hospital

  collaborator OTHER

• Wuhan Third Hospital

  collaborator OTHER

• Xiangyang Central Hospital

  collaborator OTHER

• Jingzhou Central Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-05

Primary Completion

2027-04-01

Completion

2027-04-01

Countries

• China

Study Locations