Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases
Eligible age
18–79 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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
Sponsor: Renmin Hospital of Wuhan University
You may qualify if…
- ✓ 1. Diagnosed with cardiovascular disease (CVD) and scheduled to undergo cardiology-related surgical treatment
- ✓ 2. Able to receive and tolerate the aforementioned cardiology-related surgical treatment
- ✓ 3. Aged between 18 and 79 years (inclusive), with no restriction on gender
- ✓ 4. Agree to accept random allocation of the treatment strategies
- ✓ 5. 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
You may not qualify if…
- ✕ 1. 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
- ✕ 2. Have a history of cervical infection, trauma, severe cervical deformity, or prior cervical surgery
- ✕ 3. Unable to complete the daily study intervention as required by the trial protocol
- ✕ 4. Are participating in another clinical trial, or have participated in other clinical trials with interventions that may interfere with the results of this study
- ✕ 5. Have undergone major surgery or general anesthesia within the past 30 days
- ✕ 6. Have a history of alcohol abuse
- ✕ 7. Are female subjects who are pregnant or lactating, or plan to become pregnant during the study period
- ✕ 8. Have severe cognitive impairment, severe psychiatric disorders, epilepsy, or other related neurological disorders
Source: ClinicalTrials.gov · NCT07595068 · last updated 2026-08-21