Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases (US-REST)
2026年5月12日 更新者：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
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Songyun Wang, MD
- 電話番号：+86 13871262107
- メール：wsy7982@126.com
研究場所
-
-
Hubei
-
Huangshi、Hubei、中国、430060
- Huangshi Central Hospital
-
コンタクト：
- Kai Zhang, MD
- 電話番号：+86 13907230225
- メール：zk9620@163.com
-
Jingzhou、Hubei、中国、430060
- Jingzhou Central Hospital
-
コンタクト：
- Keping Yang, MD
- 電話番号：+86 18107168679
- メール：30461400@qq.com
-
Wuhan、Hubei、中国、430060
- Renmin Hospital of Wuhan University
-
コンタクト：
- Songyun Wang, MD
- 電話番号：+86 13871262107
- メール：wsy7982@126.com
-
Wuhan、Hubei、中国、430060
- Wuhan Central Hospital
-
コンタクト：
- Long Wang, MD
- 電話番号：+86 15761600527
- メール：319921605@qq.com
-
Wuhan、Hubei、中国、430060
- Wuhan Third Hospital
-
コンタクト：
- Dongsheng Li, MD
- 電話番号：+86 18872288277
- メール：lidongsheng693@sina.com
-
Xiangyang、Hubei、中国、430060
- Xiangyang Central Hospital
-
コンタクト：
- Tongjian Zhu, MD
- 電話番号：+86 15971160197
- メール：whuzhutongjian@126.com
-
Yichang、Hubei、中国、430060
- Yichang Central People's Hospital
-
コンタクト：
- Zhuli Guo, MD
- 電話番号：+86 15271455251
- メール：guozhuli@yczxyy.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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 -
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SDNN
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
IL-1β level
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Pre-operative 24 hours and Post-operative 72 hours
|
Serum melatonin concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月5日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月12日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- WDRY2026-K085
- 82570593 (その他の助成金/資金番号：National Natural Science Foundation of China (NSFC))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
Due to considerations for protecting participant privacy, undetermined data ownership, or the absence of a detailed data-sharing policy.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。