Atrial Fibrillation (AF), Cardiovascular Diseases
Conditions
Keywords
Low-Intensity Focused Ultrasound, Cardiovascular Diseases, Stellate Ganglion, Autonomic Nervous Function, Sleep Quality
Brief 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
Interventions
DEVICELow-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.
DEVICESham 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. All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period.
Sponsors
Renmin Hospital of Wuhan University
Yichang Central People's Hospital
Wuhan Central Hospital
Huangshi Central Hospital
Wuhan Third Hospital
Xiangyang Central Hospital
Jingzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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 9. Have concomitant malignant tumor or severe dysfunction of vital organs 10. Have active systemic infection 11. Have significant bleeding tendency, or renal failure undergoing regular hemodialysis 12. Are deemed unsuitable for the trial by the investigator for any other reason -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia percentage | Pre-operative 24 hours and Post-operative 72 hours | Percentage of time with insomnia symptoms during sleep period; Unit: %; Measurement device: Wearable sleep monitor. |
| REM sleep percentage | Pre-operative 24 hours and Post-operative 72 hours | Percentage of rapid eye movement sleep during total sleep time; Unit: %; Measurement device: Wearable sleep monitor. |
| N1 sleep stage percentage | Pre-operative 24 hours and Post-operative 72 hours | Percentage of N1 sleep stage during total sleep time; Unit: %; Measurement device: Wearable sleep monitor. |
| N2 and N3 sleep stages percentage | Pre-operative 24 hours and Post-operative 72 hours | Combined percentage of N2 and N3 sleep stages during total sleep time; Unit: %; Measurement device: Wearable sleep monitor. |
| Sleep efficiency | Pre-operative 24 hours and Post-operative 72 hours | Ratio of total sleep time to time in bed; Unit: %; Measurement device: Wearable sleep monitor. |
| SDNN | Pre-operative 24 hours and Post-operative 72 hours | Standard deviation of all normal-to-normal intervals measured by wearable Holter monitor; Unit: ms; Measurement device: wearable Holter monitors. |
| Total sleep duration | Pre-operative 24 hours and Post-operative 72 hours | Total sleep time measured by wearable sleep monitor; Unit: hours; Measurement device: Wearable sleep monitor. |
| SDANN | Pre-operative 24 hours and Post-operative 72 hours | Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors. |
| SDNN Index | Pre-operative 24 hours and Post-operative 72 hours | Mean of the standard deviations of all NN intervals for all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors. |
| RMSSD | Pre-operative 24 hours and Post-operative 72 hours | Root mean square of successive differences between normal heartbeats; Unit: ms; Measurement device: wearable Holter monitors. |
| pNN50 | Pre-operative 24 hours and Post-operative 72 hours | Percentage of successive NN intervals that differ by more than 50 ms; Unit: %; Measurement device: wearable Holter monitors. |
| LF power | Pre-operative 24 hours and Post-operative 72 hours | Low frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors. |
| HF power | Pre-operative 24 hours and Post-operative 72 hours | High frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors. |
| TP | Pre-operative 24 hours and Post-operative 72 hours | Total power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors. |
| LF/HF ratio | Pre-operative 24 hours and Post-operative 72 hours | Ratio of low frequency to high frequency power; Unit: ratio; Measurement device: wearable Holter monitors. |
| Wakefulness percentage | Pre-operative 24 hours and Post-operative 72 hours | Percentage of time awake during sleep period; Unit: %; Measurement device: Wearable sleep monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score | Pre-operative 24 hours and Post-operative 72 hours | Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index questionnaire; Unit: Score on a 0-21 scale, where higher scores indicate worse sleep quality; Method of Measurement: Self-administered questionnaire. |
| Duration of atrial arrhythmias | Pre-operative 24 hours and Post-operative 72 hours | Measurement: Duration of atrial arrhythmia episodes. Measurement device: wearable Holter monitors. |
| TNF-α level | Pre-operative 24 hours and Post-operative 72 hours | Serum TNF-α concentration; Unit: pg/mL. |
| Neuropeptide Y (NPY) level | Pre-operative 24 hours and Post-operative 72 hours | Serum neuropeptide Y concentration; Unit: pg/mL. |
| Melatonin level | Pre-operative 24 hours and Post-operative 72 hours | Serum melatonin concentration; Unit: pg/mL. |
| IL-1β level | Pre-operative 24 hours and Post-operative 72 hours | Serum IL-1β concentration; Unit: pg/mL. |
| Norepinephrine (NE) level | Pre-operative 24 hours and Post-operative 72 hours | Serum norepinephrine concentration; Unit: pg/mL. |
| Brain-derived neurotrophic factor (BDNF) level | Pre-operative 24 hours and Post-operative 72 hours | Serum brain-derived neurotrophic factor concentration; Unit: pg/mL. |
| Number of atrial arrhythmias | Pre-operative 24 hours and Post-operative 72 hours | Measurement: count of atrial arrhythmia episodes. Measurement device: wearable Holter monitors. |
Countries
China
Contacts
CONTACTSongyun Wang, MD
Outcome results
None listed