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

19 augustus 2026 bijgewerkt door: Songyun Wang, Renmin Hospital of Wuhan University

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Songyun Wang, MD
  • Telefoonnummer: +86 13871262107
  • E-mail: wsy7982@126.com

Studie Locaties

  • China
    • Hubei
      • Huangshi, Hubei, China, 430060
        • Nog niet aan het werven
        • Huangshi Central Hospital
        • Contact:
          • Kai Zhang, MD
          • Telefoonnummer: +86 13907230225
          • E-mail: zk9620@163.com
      • Jingzhou, Hubei, China, 430060
        • Nog niet aan het werven
        • Jingzhou Central Hospital
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Werving
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Nog niet aan het werven
        • Wuhan Third Hospital
        • Contact:
      • Wuhan, Hubei, China, 430060
        • Nog niet aan het werven
        • Wuhan Central Hospital
        • Contact:
      • Xiangyang, Hubei, China, 430060
        • Nog niet aan het werven
        • Xiangyang Central Hospital
        • Contact:
      • Yichang, Hubei, China, 430060
        • Nog niet aan het werven
        • Yichang Central People's Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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 -

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Low-Intensity Focused Ultrasound (LIFU) Intervention Arm
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.
Apparaat: Low-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.
Placebo-vergelijker: Sham Ultrasound Control Arm (Placebo)
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.
Apparaat: Sham 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
SDNN
Tijdsspanne: 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.
Pre-operative 24 hours and Post-operative 72 hours
Total sleep duration
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
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
Tijdsspanne: 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.
Pre-operative 24 hours and Post-operative 72 hours
SDNN Index
Tijdsspanne: 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.
Pre-operative 24 hours and Post-operative 72 hours
RMSSD
Tijdsspanne: 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.
Pre-operative 24 hours and Post-operative 72 hours
pNN50
Tijdsspanne: 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.
Pre-operative 24 hours and Post-operative 72 hours
LF power
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
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
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
High frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
Pre-operative 24 hours and Post-operative 72 hours
TP
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
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
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
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
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Percentage of time awake during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
Pre-operative 24 hours and Post-operative 72 hours
Insomnia percentage
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
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
Tijdsspanne: 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.
Pre-operative 24 hours and Post-operative 72 hours
N1 sleep stage percentage
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
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
Tijdsspanne: 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.
Pre-operative 24 hours and Post-operative 72 hours
Sleep efficiency
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Ratio of total sleep time to time in bed; Unit: %; Measurement device: Wearable sleep monitor.
Pre-operative 24 hours and Post-operative 72 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
IL-1β level
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Serum IL-1β concentration; Unit: pg/mL.
Pre-operative 24 hours and Post-operative 72 hours
Norepinephrine (NE) level
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Serum norepinephrine concentration; Unit: pg/mL.
Pre-operative 24 hours and Post-operative 72 hours
Brain-derived neurotrophic factor (BDNF) level
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Serum brain-derived neurotrophic factor concentration; Unit: pg/mL.
Pre-operative 24 hours and Post-operative 72 hours
Pittsburgh Sleep Quality Index (PSQI) score
Tijdsspanne: 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.
Pre-operative 24 hours and Post-operative 72 hours
Number of atrial arrhythmias
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Measurement: count of atrial arrhythmia episodes. Measurement device: wearable Holter monitors.
Pre-operative 24 hours and Post-operative 72 hours
Duration of atrial arrhythmias
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Measurement: Duration of atrial arrhythmia episodes. Measurement device: wearable Holter monitors.
Pre-operative 24 hours and Post-operative 72 hours
TNF-α level
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Serum TNF-α concentration; Unit: pg/mL.
Pre-operative 24 hours and Post-operative 72 hours
Neuropeptide Y (NPY) level
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Serum neuropeptide Y concentration; Unit: pg/mL.
Pre-operative 24 hours and Post-operative 72 hours
Melatonin level
Tijdsspanne: Pre-operative 24 hours and Post-operative 72 hours
Serum melatonin concentration; Unit: pg/mL.
Pre-operative 24 hours and Post-operative 72 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Renmin Hospital of Wuhan University

Medewerkers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 mei 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 april 2027

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

19 augustus 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • WDRY2026-K085
  • 82570593 (Ander subsidie-/financieringsnummer: National Natural Science Foundation of China (NSFC))

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Beschrijving IPD-plan

Due to considerations for protecting participant privacy, undetermined data ownership, or the absence of a detailed data-sharing policy.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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