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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)

12. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

  • Kina
    • Hubei
      • Huangshi, Hubei, Kina, 430060
        • Huangshi Central Hospital
        • Kontakt:
      • Jingzhou, Hubei, Kina, 430060
        • Jingzhou Central Hospital
        • Kontakt:
      • Wuhan, Hubei, Kina, 430060
        • Renmin Hospital of Wuhan University
        • Kontakt:
      • Wuhan, Hubei, Kina, 430060
        • Wuhan Central Hospital
        • Kontakt:
      • Wuhan, Hubei, Kina, 430060
      • Xiangyang, Hubei, Kina, 430060
        • Xiangyang Central Hospital
        • Kontakt:
      • Yichang, Hubei, Kina, 430060
        • Yichang Central People's Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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 -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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 komparator: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SDNN
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
IL-1β level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Pre-operative 24 hours and Post-operative 72 hours
Serum melatonin concentration; Unit: pg/mL.
Pre-operative 24 hours and Post-operative 72 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Renmin Hospital of Wuhan University

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

5. maj 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WDRY2026-K085
  • 82570593 (Andet bevillings-/finansieringsnummer: National Natural Science Foundation of China (NSFC))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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

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