Low-intensity ultrasound to calm the nerves and improve sleep after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, randomized controlled trial will enroll adults with cardiovascular disease undergoing cardiology-related surgery. Participants will receive either active low-intensity focused ultrasound targeting the left stellate ganglion or a sham procedure, daily for 3–7 days, in addition to standard care. The study will assess heart rate variability, sleep quality, serological markers, vital signs, and perioperative arrhythmias, with safety monitored closely. The design includes blinding of participants, operators, assessors, and analysts to minimize bias. The trial is led by Renmin Hospital of Wuhan University with several collaborating centers in Hubei province and is expected to begin in May 2026.

Why it matters

Who can join: the full rules

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 -

Where it's running

• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Huangshi Central Hospital
  Huangshi, Hubei, China Not yet recruiting
• Jingzhou Central Hospital
  Jingzhou, Hubei, China Not yet recruiting
• Wuhan Central Hospital
  Wuhan, Hubei, China Not yet recruiting
• Wuhan Third Hospital
  Wuhan, Hubei, China Not yet recruiting
• Xiangyang Central Hospital
  Xiangyang, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Songyun Wang, MD
• Email: wsy7982@126.com
• Phone: +86 13871262107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.