Focused Ultrasound on a Neck Nerve for Heart Rhythm and Sleep After Surgery
Tests focused ultrasound on a neck nerve in adults with heart disease after surgery.
Plain-language title generated from the registry record
Registry title: Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases
Key facts
- Where
- Huangshi, Jingzhou, Wuhan, Xiangyang, and Yichang, ChinaSee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 79 years old?
Source: NCT07595068, who can take part
Where in China
- Huangshi Central HospitalHuangshi, ChinaNot yet recruiting
- Jingzhou Central HospitalJingzhou, ChinaNot yet recruiting
- Renmin Hospital of Wuhan UniversityWuhan, ChinaTaking people
- Wuhan Central HospitalWuhan, ChinaNot yet recruiting
- Wuhan Third HospitalWuhan, ChinaNot yet recruiting
- Xiangyang Central HospitalXiangyang, ChinaNot yet recruiting
- Yichang Central People's HospitalYichang, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Renmin Hospital of Wuhan University
- Trial code
- NCT07595068
- Record updated
- 21 August 2026
- Original description
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.Read full original descriptionShow less
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
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
Inclusion: 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: 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; 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; 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 -.