Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve F… (NCT07595068) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases
China200 participantsStarted 2026-05-05
Plain-language 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
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SDNN
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
2
Total sleep duration
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
3
SDANN
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
4
SDNN Index
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
5
RMSSD
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
6
pNN50
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
7
LF power
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
. 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
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
9
TP
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
10
LF/HF ratio
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
11
Wakefulness percentage
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
12
Insomnia percentage
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
13
REM sleep percentage
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
14
N1 sleep stage percentage
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
15
N2 and N3 sleep stages percentage
Timeframe: Pre-operative 24 hours and Post-operative 72 hours
16
Sleep efficiency
Timeframe: Pre-operative 24 hours and Post-operative 72 hours