Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases (US-REST)
2026년 5월 12일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Songyun Wang, MD
- 전화번호: +86 13871262107
- 이메일: wsy7982@126.com
연구 장소
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Hubei
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Huangshi, Hubei, 중국, 430060
- Huangshi Central Hospital
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연락하다:
- Kai Zhang, MD
- 전화번호: +86 13907230225
- 이메일: zk9620@163.com
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Jingzhou, Hubei, 중국, 430060
- Jingzhou Central Hospital
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연락하다:
- Keping Yang, MD
- 전화번호: +86 18107168679
- 이메일: 30461400@qq.com
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Wuhan, Hubei, 중국, 430060
- Renmin Hospital of Wuhan University
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연락하다:
- Songyun Wang, MD
- 전화번호: +86 13871262107
- 이메일: wsy7982@126.com
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Wuhan, Hubei, 중국, 430060
- Wuhan Central Hospital
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연락하다:
- Long Wang, MD
- 전화번호: +86 15761600527
- 이메일: 319921605@qq.com
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Wuhan, Hubei, 중국, 430060
- Wuhan Third Hospital
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연락하다:
- Dongsheng Li, MD
- 전화번호: +86 18872288277
- 이메일: lidongsheng693@sina.com
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Xiangyang, Hubei, 중국, 430060
- Xiangyang Central Hospital
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연락하다:
- Tongjian Zhu, MD
- 전화번호: +86 15971160197
- 이메일: whuzhutongjian@126.com
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Yichang, Hubei, 중국, 430060
- Yichang Central People's Hospital
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연락하다:
- Zhuli Guo, MD
- 전화번호: +86 15271455251
- 이메일: guozhuli@yczxyy.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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 -
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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SDNN
기간: 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.
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Pre-operative 24 hours and Post-operative 72 hours
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Total sleep duration
기간: Pre-operative 24 hours and Post-operative 72 hours
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Total sleep time measured by wearable sleep monitor; Unit: hours; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
|
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SDANN
기간: 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.
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Pre-operative 24 hours and Post-operative 72 hours
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SDNN Index
기간: 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.
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Pre-operative 24 hours and Post-operative 72 hours
|
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RMSSD
기간: 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.
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Pre-operative 24 hours and Post-operative 72 hours
|
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pNN50
기간: 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.
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Pre-operative 24 hours and Post-operative 72 hours
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LF power
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Low frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
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Pre-operative 24 hours and Post-operative 72 hours
|
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HF power
기간: Pre-operative 24 hours and Post-operative 72 hours
|
High frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
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Pre-operative 24 hours and Post-operative 72 hours
|
|
TP
기간: 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
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Ratio of low frequency to high frequency power; Unit: ratio; Measurement device: wearable Holter monitors.
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Pre-operative 24 hours and Post-operative 72 hours
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Wakefulness percentage
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Percentage of time awake during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
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Insomnia percentage
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Percentage of time with insomnia symptoms during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
|
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REM sleep percentage
기간: 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.
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Pre-operative 24 hours and Post-operative 72 hours
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N1 sleep stage percentage
기간: Pre-operative 24 hours and Post-operative 72 hours
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Percentage of N1 sleep stage during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
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N2 and N3 sleep stages percentage
기간: Pre-operative 24 hours and Post-operative 72 hours
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Combined percentage of N2 and N3 sleep stages during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
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Sleep efficiency
기간: Pre-operative 24 hours and Post-operative 72 hours
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Ratio of total sleep time to time in bed; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
IL-1β level
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Serum IL-1β concentration; Unit: pg/mL.
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Pre-operative 24 hours and Post-operative 72 hours
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Norepinephrine (NE) level
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Serum norepinephrine concentration; Unit: pg/mL.
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Pre-operative 24 hours and Post-operative 72 hours
|
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Brain-derived neurotrophic factor (BDNF) level
기간: 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
|
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Pittsburgh Sleep Quality Index (PSQI) score
기간: Pre-operative 24 hours and Post-operative 72 hours
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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.
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Pre-operative 24 hours and Post-operative 72 hours
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Number of atrial arrhythmias
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Measurement: count of atrial arrhythmia episodes.
Measurement device: wearable Holter monitors.
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Pre-operative 24 hours and Post-operative 72 hours
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Duration of atrial arrhythmias
기간: Pre-operative 24 hours and Post-operative 72 hours
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Measurement: Duration of atrial arrhythmia episodes.
Measurement device: wearable Holter monitors.
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Pre-operative 24 hours and Post-operative 72 hours
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TNF-α level
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Serum TNF-α concentration; Unit: pg/mL.
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Pre-operative 24 hours and Post-operative 72 hours
|
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Neuropeptide Y (NPY) level
기간: 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
|
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Melatonin level
기간: Pre-operative 24 hours and Post-operative 72 hours
|
Serum melatonin concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 5일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2027년 4월 1일
연구 등록 날짜
최초 제출
2026년 4월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- WDRY2026-K085
- 82570593 (기타 보조금/기금 번호: National Natural Science Foundation of China (NSFC))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
Due to considerations for protecting participant privacy, undetermined data ownership, or the absence of a detailed data-sharing policy.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .