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

Official title

Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases: A Multicenter, Double-Blind, Randomized Controlled Trial

Overview

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

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. A

Primary outcome measures

• SDNN [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• Total sleep duration [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• SDANN [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• SDNN Index [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• RMSSD [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• pNN50 [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• LF power [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• HF power [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• TP [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• LF/HF ratio [Time frame: Pre-operative 24 hours and Post-operative 72 hours]

Secondary outcome measures (9)

• IL-1β level [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• Norepinephrine (NE) level [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• Brain-derived neurotrophic factor (BDNF) level [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• Pittsburgh Sleep Quality Index (PSQI) score [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• Number of atrial arrhythmias [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• Duration of atrial arrhythmias [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• TNF-α level [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• Neuropeptide Y (NPY) level [Time frame: Pre-operative 24 hours and Post-operative 72 hours]
• Melatonin level [Time frame: Pre-operative 24 hours and Post-operative 72 hours]

Eligibility criteria

Inclusion criteria

• 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
• With clear consciousness, no severe mental disorders or cognitive impairment; voluntarily sign the written informed consent form (ICF) and are willing to actively cooperate with the study treatment

Exclusion criteria

• 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
• Have undergone major surgery or general anesthesia within the past 30 days
• Have a history of alcohol abuse
• Are female subjects who are pregnant or lactating, or plan to become pregnant during the study period
• Have severe cognitive impairment, severe psychiatric disorders, epilepsy, or other related neurological disorders
• Have concomitant malignant tumor or severe dysfunction of vital organs
• Have active systemic infection
• Have significant bleeding tendency, or renal failure undergoing regular hemodialysis
• Are deemed unsuitable for the trial by the investigator for any other reason -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 7 centers

• Huangshi Central Hospital — Huangshi
• Jingzhou Central Hospital — Jingzhou
• Renmin Hospital of Wuhan University — Wuhan
• Wuhan Central Hospital — Wuhan
• Wuhan Third Hospital — Wuhan
• Xiangyang Central Hospital — Xiangyang
• Yichang Central People's Hospital — Yichang

Identifiers

NCT: NCT07595068 · WDRY2026-K085 · 82570593

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗