insomnia associated with Metabolic dysfunction-associated steatotic liver disease
Conditions
Interventions
Electroacupuncture group:electroacupuncture
Sham acupuncture group:sham acupuncture
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 70 years old (inclusive), gender unrestricted; 2. Meeting the Western medical diagnostic criteria for MASLD; 3. Diagnosed with MASLD using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), with MRI-PDFF = 5%; 4. Meeting the diagnostic criteria for chronic insomnia as stipulated in ICSD-3; 5. Having continuously and stably used sedative-hypnotic drugs for more than 3 months or never having used such drugs; 6. Pittsburgh Sleep Quality Index (PSQI) score > 7; 7. No severe cognitive or mental disorders, and able to understand and complete the scale assessment; 8. The patient agrees to participate in this clinical study, voluntarily signs the informed consent form, and agrees to participate in all visits, examinations, and treatments as required by the research protocol.
Exclusion criteria
Exclusion criteria: 1. Through medical history and laboratory tests, there is suspicion of other causes of liver and biliary diseases, including but not limited to: hepatitis B or C virus infection, alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, liver cirrhosis, primary sclerosing cholangitis, Wilson's disease, alpha-1 antitrypsin deficiency, liver cancer (or with a family history of liver cancer), etc.; 2. There are clinical evidences suggesting the presence of liver cirrhosis or liver decompensation; 3. Severe renal insufficiency, defined as serum creatinine (Scr) = 178 µmol/L, or estimated glomerular filtration rate (eGFR) < 60 ml/min; 4. Have severe primary diseases in the cardiovascular, cerebrovascular, urinary, and hematopoietic systems, malignant tumors, other severe comorbidities, or mental disorders; 5. Have type 1 diabetes or uncontrolled type 2 diabetes, defined as HbA1c = 9.5%, or have adjusted hypoglycemic drugs within 2 months before enrollment, or have experienced severe hypoglycemic events in the past; 6. Have thyroid diseases, including hyperthyroidism, hypothyroidism, and subclinical hypothyroidism; 7. Have untreated sleep disorders other than chronic insomnia, such as obstructive sleep apnea, narcolepsy, restless legs syndrome, periodic limb movement disorder, delayed sleep phase syndrome, or central sleep apnea syndrome, as well as irregular sleep patterns or shift work; 8. Have severe depression, severe anxiety, schizophrenia, or other severe mental disorders; 9. Have a history of drug or alcohol dependence; 10. Have received acupuncture treatment in the past; 11. Have skin lesions or infections; 12. Have implanted cardiac pacemakers/defibrillators or other implantable electronic devices, or have metal implants in the body that may be affected by current; 13. Pregnant and lactating women, and women who refuse to maintain the contraceptive measures recognized by the researchers throughout the study and have the possibility of pregnancy; 14. Have participated in other clinical trials in the past 3 months; 15. Cannot follow the doctor's advice to implement lifestyle interventions; 16.The researcher deems there are other conditions that make the patient unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Beck Anxiety Inventory;Beck Depression Inventory-II;Fatigue Severity Scale;Epworth Sleepiness Scale;FibroScan;Liver and kidney function;blood lipids; Fasting Plasma Glucose;Homeostasis Model Assessment of Insulin Resistance; | — |
Countries
China
Contacts
Public ContactLingying Huang
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed