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. května 2026 aktualizováno: 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:
- Does LIFU improve heart rate variability and sleep characteristics from baseline at 3-7 days post-surgery compared to sham ultrasound?
- Does LIFU improve serological markers, vital signs, Pittsburgh Sleep Quality Index (PSQI), and reduce >30-second perioperative arrhythmias?
- 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:
- Complete pre-surgery screening and baseline assessments (PSQI, 12h ECG/sleep monitoring, residual blood sample collection)
- Receive daily assigned ultrasound intervention for 3-7 consecutive days post-surgery
- Undergo 72h continuous ECG monitoring post-surgery, and repeat assessments at 3-7 days
- Have all adverse events and arrhythmias recorded throughout the study
- May withdraw voluntarily at any time without affecting routine medical care
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
200
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Songyun Wang, MD
- Telefonní číslo: +86 13871262107
- E-mail: wsy7982@126.com
Studijní místa
-
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Hubei
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Huangshi, Hubei, Čína, 430060
- Huangshi Central Hospital
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Kontakt:
- Kai Zhang, MD
- Telefonní číslo: +86 13907230225
- E-mail: zk9620@163.com
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Jingzhou, Hubei, Čína, 430060
- Jingzhou Central Hospital
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Kontakt:
- Keping Yang, MD
- Telefonní číslo: +86 18107168679
- E-mail: 30461400@qq.com
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Wuhan, Hubei, Čína, 430060
- Renmin Hospital of Wuhan University
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Kontakt:
- Songyun Wang, MD
- Telefonní číslo: +86 13871262107
- E-mail: wsy7982@126.com
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Wuhan, Hubei, Čína, 430060
- Wuhan Central Hospital
-
Kontakt:
- Long Wang, MD
- Telefonní číslo: +86 15761600527
- E-mail: 319921605@qq.com
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Wuhan, Hubei, Čína, 430060
- Wuhan Third Hospital
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Kontakt:
- Dongsheng Li, MD
- Telefonní číslo: +86 18872288277
- E-mail: lidongsheng693@sina.com
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Xiangyang, Hubei, Čína, 430060
- Xiangyang Central Hospital
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Kontakt:
- Tongjian Zhu, MD
- Telefonní číslo: +86 15971160197
- E-mail: whuzhutongjian@126.com
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Yichang, Hubei, Čína, 430060
- Yichang Central People's Hospital
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Kontakt:
- Zhuli Guo, MD
- Telefonní číslo: +86 15271455251
- E-mail: guozhuli@yczxyy.com
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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 -
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
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Komparátor placeba: 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.
|
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
SDNN
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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LF/HF ratio
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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N2 and N3 sleep stages percentage
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
IL-1β level
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Number of atrial arrhythmias
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Pre-operative 24 hours and Post-operative 72 hours
|
Serum melatonin concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
5. května 2026
Primární dokončení (Odhadovaný)
1. dubna 2027
Dokončení studie (Odhadovaný)
1. dubna 2027
Termíny zápisu do studia
První předloženo
28. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
12. května 2026
První zveřejněno (Aktuální)
19. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
19. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. května 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- WDRY2026-K085
- 82570593 (Jiné číslo grantu/financování: National Natural Science Foundation of China (NSFC))
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Due to considerations for protecting participant privacy, undetermined data ownership, or the absence of a detailed data-sharing policy.
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Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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