AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases

RecruitingNAAges 18 Years - 79 YearsAllRenmin Hospital of Wuhan University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 -
๐Ÿ’Š

What it tests

  • Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion
  • Sham low-intensity focused ultrasound targeting the left stellate ganglion
๐Ÿ“

Where

7 sites
Huangshi Central Hospital
Huangshi, China
Jingzhou Central Hospital
Jingzhou, China
Renmin Hospital of Wuhan University
Wuhan, China
Wuhan Central Hospital
Wuhan, China
Wuhan Third Hospital
Wuhan, China
Xiangyang Central Hospital
Xiangyang, China
Yichang Central People's Hospital
Yichang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy