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
Diagnosed with cardiovascular disease (CVD) and scheduled to undergo cardiology-related surgical treatment
Able to receive and tolerate the aforementioned cardiology-related surgical treatment
Aged between 18 and 79 years (inclusive), with no restriction on gender
Agree to accept random allocation of the treatment strategies
Have used sedative-hypnotic drugs, antipsychotic drugs, opioid analgesics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), central nervous system (CNS) stimulant drugs, or any other medications that alter sleep architecture within the past 30 days
Have a history of cervical infection, trauma, severe cervical deformity, or prior cervical surgery
Unable to complete the daily study intervention as required by the trial protocol
Are participating in another clinical trial, or have participated in other clinical trials with interventions that may interfere with the results of this study
Parallel
Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion
DeviceThe 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.
Sham low-intensity focused ultrasound targeting the left stellate ganglion
DeviceThe 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.
SDNN
Standard deviation of all normal-to-normal intervals measured by wearable Holter monitor; Unit: ms; Measurement device: wearable Holter monitors.
Total sleep duration
Total sleep time measured by wearable sleep monitor; Unit: hours; Measurement device: Wearable sleep monitor.
SDANN
Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.
SDNN Index
Mean of the standard deviations of all NN intervals for all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.
IL-1β level
Serum IL-1β concentration; Unit: pg/mL.
Norepinephrine (NE) level
Serum norepinephrine concentration; Unit: pg/mL.
Brain-derived neurotrophic factor (BDNF) level
Serum brain-derived neurotrophic factor concentration; Unit: pg/mL.
Pittsburgh Sleep Quality Index (PSQI) score
Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index questionnaire; Unit: Score on a 0-21 scale, where higher scores indicate worse sleep quality; Method of Measurement: Self-administered questionnaire.
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Renmin Hospital of Wuhan University
Lead sponsor
Yichang Central People's Hospital
Collaborator
Wuhan Central Hospital
Collaborator
Huangshi Central Hospital
Collaborator
Wuhan Third Hospital
Collaborator
Xiangyang Central Hospital
Collaborator
Jingzhou Central Hospital
Collaborator
