NCT07595068Recruiting
Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 28 Apr 2026
- Start date
- 20 May 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Renmin Hospital of Wuhan University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07595068
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 20 May 2026 to the primary completion date, 1 Apr 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Have undergone major surgery or general anesthesia within the past 30 days
- Have concomitant malignant tumor or severe dysfunction of vital organs
Other illness
- Have a history of alcohol abuse
- Have severe cognitive impairment, severe psychiatric disorders, epilepsy, or other related neurological disorders
- Have active systemic infection
- Have significant bleeding tendency, or renal failure undergoing regular hemodialysis
Other
- 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
- Are female subjects who are pregnant or lactating, or plan to become pregnant during the study period
- Are deemed unsuitable for the trial by the investigator for any other reason -
Who the study is looking for
- 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
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huangshi Central Hospital Coordinator of this site? Confirm its status | Huangshi | China | Not yet recruiting |
| Jingzhou Central Hospital Coordinator of this site? Confirm its status | Jingzhou | China | Not yet recruiting |
| Wuhan Central Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Wuhan Third Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Not yet recruiting |
| Yichang Central People's Hospital Coordinator of this site? Confirm its status | Yichang | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.