Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases

NCT07595068 | Not Yet Recruiting

• 2 other identifiers: WDRY2026-K08582570593
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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. 1.Does LIFU improve heart rate variability and sleep characteristics from baseline at 3-7 days post-surgery compared to sham ultrasound?
2. 2.Does LIFU improve serological markers, vital signs, Pittsburgh Sleep Quality Index (PSQI), and reduce \>30-second perioperative arrhythmias?
3. 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.
4. 4.Complete pre-surgery screening and baseline assessments (PSQI, 12h ECG/sleep monitoring, residual blood sample collection)
5. 5.Receive daily assigned ultrasound intervention for 3-7 consecutive days post-surgery
6. 6.Undergo 72h continuous ECG monitoring post-surgery, and repeat assessments at 3-7 days
7. 7.Have all adverse events and arrhythmias recorded throughout the study
8. 8.May withdraw voluntarily at any time without affecting routine medical care

Conditions

Diagnosed With Cardiovascular Diseases and Scheduled to Undergo Interventional Cardiology Procedures

Keywords

Low-Intensity Focused Ultrasound; Cardiovascular Diseases; Stellate Ganglion; Autonomic Nervous Function; Sleep Quality

Outcome Measures

Primary Outcomes (16)

• SDNN

  Standard deviation of all normal-to-normal intervals measured by wearable Holter monitor; Unit: ms; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• Total sleep duration

  Total sleep time measured by wearable sleep monitor; Unit: hours; Measurement device: Wearable sleep monitor.

  Pre-operative 24 hours and Post-operative 72 hours

• SDANN

  Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• SDNN Index

  Mean of the standard deviations of all NN intervals for all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• RMSSD

  Root mean square of successive differences between normal heartbeats; Unit: ms; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• pNN50

  Percentage of successive NN intervals that differ by more than 50 ms; Unit: %; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• LF power

  Low frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• HF power

  High frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• TP

  Total power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• LF/HF ratio

  Ratio of low frequency to high frequency power; Unit: ratio; Measurement device: wearable Holter monitors.

  Pre-operative 24 hours and Post-operative 72 hours

• Wakefulness percentage

  Percentage of time awake during sleep period; Unit: %; Measurement device: Wearable sleep monitor.

  Pre-operative 24 hours and Post-operative 72 hours

• Insomnia percentage

  Percentage of time with insomnia symptoms during sleep period; Unit: %; Measurement device: Wearable sleep monitor.

  Pre-operative 24 hours and Post-operative 72 hours

• REM sleep percentage

  Percentage of rapid eye movement sleep during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.

  Pre-operative 24 hours and Post-operative 72 hours

• N1 sleep stage percentage

  Percentage of N1 sleep stage during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.

  Pre-operative 24 hours and Post-operative 72 hours

• N2 and N3 sleep stages percentage

  Combined percentage of N2 and N3 sleep stages during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.

  Pre-operative 24 hours and Post-operative 72 hours

• Sleep efficiency

  Ratio of total sleep time to time in bed; Unit: %; Measurement device: Wearable sleep monitor.

  Pre-operative 24 hours and Post-operative 72 hours

Secondary Outcomes (9)

• IL-1β level

  Pre-operative 24 hours and Post-operative 72 hours

• Norepinephrine (NE) level

  Pre-operative 24 hours and Post-operative 72 hours

• Brain-derived neurotrophic factor (BDNF) level

  Pre-operative 24 hours and Post-operative 72 hours

• Pittsburgh Sleep Quality Index (PSQI) score

  Pre-operative 24 hours and Post-operative 72 hours

• Number of atrial arrhythmias

  Pre-operative 24 hours and Post-operative 72 hours

Study Arms (2)

Low-Intensity Focused Ultrasound (LIFU) Intervention Arm

EXPERIMENTAL

Subjects in this arm will receive low-intensity focused ultrasound (LIFU) intervention on the left stellate ganglion. Ultrasound parameters: power 2.0 W, frequency 1 MHz, 50% duty cycle, 30 minutes per session, once daily for 3-7 consecutive days. All subjects will receive guideline-concordant standard perioperative cardiovascular care, including surgery and indicated medications.

Device: Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion

Sham Ultrasound Control Arm (Placebo)

PLACEBO COMPARATOR

Subjects in this arm will receive sham ultrasound intervention with identical operational procedures, device appearance, and parameter settings (no actual energy output) as the intervention arm. Sessions are once daily for 3-7 consecutive days. All subjects will receive the same guideline-concordant standard perioperative cardiovascular care as the intervention arm.

Device: Sham low-intensity focused ultrasound targeting the left stellate ganglion

Interventions

Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion DEVICE

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.

Low-Intensity Focused Ultrasound (LIFU) Intervention Arm

Sham low-intensity focused ultrasound targeting the left stellate ganglion DEVICE

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.

Sham Ultrasound Control Arm (Placebo)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Have concomitant malignant tumor or severe dysfunction of vital organs
• Have active systemic infection
• Have significant bleeding tendency, or renal failure undergoing regular hemodialysis
• Are deemed unsuitable for the trial by the investigator for any other reason -

Sponsors & Collaborators

• Huangshi Central Hospital: collaborator
• Wuhan Third Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• Jingzhou Central Hospital: collaborator
• Renmin Hospital of Wuhan University: lead
• Yichang Central People's Hospital: collaborator
• Wuhan Central Hospital: collaborator

Study Sites (7)

Huangshi Central Hospital

Huangshi, Hubei, 430060, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, 430060, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Wuhan Central Hospital

Wuhan, Hubei, 430060, China

Location

Wuhan Third Hospital

Wuhan, Hubei, 430060, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 430060, China

Location

Yichang Central People's Hospital

Yichang, Hubei, 430060, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Songyun Wang, MD

CONTACT

+86 13871262107; wsy7982@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician & Associate Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 19, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-04

Locations

CN (7)