Cardiovascular diseases
Conditions
Interventions
Control Group (Sham ultrasound intervention control group):Sham ultrasound blank control intervention
Experimental Group (Low-intensity focused ultrasound stellate ganglion modulation group):Low-intensity focused ultrasound for stellate ganglion modulation intervention
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate variability;Sleep quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory markers (IL-1ß, TNF-a), sympathetic neurotransmitters (NE, NPY), sleep-related markers (BDNF, Melatonin); | — |
Countries
China
Contacts
Public ContactSongyun Wang;Hong Jiang
Renmin Hospital of Wuhan University
Outcome results
None listed