Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07595068

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diagnosed With Cardiovascular Diseases and Scheduled to Undergo Interventional Cardiology Procedures Cardiovascular Diseases Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huangshi Central Hospital, Huangshi, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 -

Treatment and study plan

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.

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.

Primary outcomes

  1. SDNN

    Time frame: 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.

  2. Total sleep duration

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

  3. SDANN

    Time frame: 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.

  4. SDNN Index

    Time frame: 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.

  5. RMSSD

    Time frame: 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.

  6. pNN50

    Time frame: 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.

  7. LF power

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

  8. HF power

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

  9. TP

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

  10. LF/HF ratio

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

  11. Wakefulness percentage

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

  12. Insomnia percentage

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

  13. REM sleep percentage

    Time frame: 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.

  14. N1 sleep stage percentage

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

  15. N2 and N3 sleep stages percentage

    Time frame: 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.

  16. Sleep efficiency

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

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

Secondary outcomes

  1. IL-1β level

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

    Serum IL-1β concentration; Unit: pg/mL.

  2. Norepinephrine (NE) level

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

    Serum norepinephrine concentration; Unit: pg/mL.

  3. Brain-derived neurotrophic factor (BDNF) level

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

    Serum brain-derived neurotrophic factor concentration; Unit: pg/mL.

  4. Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: 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.

  5. Number of atrial arrhythmias

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

    Measurement: count of atrial arrhythmia episodes. Measurement device: wearable Holter monitors.

  6. Duration of atrial arrhythmias

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

    Measurement: Duration of atrial arrhythmia episodes. Measurement device: wearable Holter monitors.

  7. TNF-α level

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

    Serum TNF-α concentration; Unit: pg/mL.

  8. Neuropeptide Y (NPY) level

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

    Serum neuropeptide Y concentration; Unit: pg/mL.

  9. Melatonin level

    Time frame: Pre-operative 24 hours and Post-operative 72 hours

    Serum melatonin concentration; Unit: pg/mL.

Study contacts

Contact information is provided by the study sponsor or research team.

Songyun Wang, MD

CONTACT

[email protected]

+86 13871262107

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Collaborators

  • Huangshi Central Hospital
  • Jingzhou Central Hospital
  • Wuhan Central Hospital
  • Wuhan Third Hospital
  • Xiangyang Central Hospital
  • Yichang Central People's Hospital

Registry information

Official study title

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

Acronym: US-REST

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.