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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. mai 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

  • Kina
    • Hubei
      • Huangshi, Hubei, Kina, 430060
        • Huangshi Central Hospital
        • Ta kontakt med:
      • Jingzhou, Hubei, Kina, 430060
        • Jingzhou Central Hospital
        • Ta kontakt med:
      • Wuhan, Hubei, Kina, 430060
        • Renmin Hospital of Wuhan University
        • Ta kontakt med:
      • Wuhan, Hubei, Kina, 430060
        • Wuhan Central Hospital
        • Ta kontakt med:
      • Wuhan, Hubei, Kina, 430060
        • Wuhan Third Hospital
        • Ta kontakt med:
      • Xiangyang, Hubei, Kina, 430060
        • Xiangyang Central Hospital
        • Ta kontakt med:
      • Yichang, Hubei, Kina, 430060
        • Yichang Central People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Renmin Hospital of Wuhan University

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

5. mai 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. april 2027

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

19. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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