Refractory insomnia
Conditions
Interventions
Intervention Group:Titrated sedation with Ciprofol injection
Sponsors
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–65 years, regardless of gender. 2.American Society of Anesthesiologists (ASA) physical status classification I-?I. 3.Meeting the diagnostic criteria for chronic insomnia disorder in the International Classification of Sleep Disorders, 3rd Edition (ICSD-3), with an Insomnia Severity Index (ISI) score >=15 in the recent 2 weeks. 4.Meeting the diagnostic criteria for depressive disorders in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), with a 21-item Hamilton Depression Rating Scale (HAMD-21) score >=18. 5.Poor therapeutic response to >=1 benzodiazepine receptor agonist within 3 months prior to enrollment (excluding melatonin receptor agonists, antidepressants, anxiolytics and other psychotropic drugs). 6.Voluntarily receiving intravenous anesthetic treatment and providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other mental disorders: bipolar disorder, schizophrenia, schizoaffective disorder, organic mental disorders, substance use disorders (excluding nicotine dependence), autism spectrum disorders, etc.; 2. Personality disorders (borderline, antisocial, etc.) and intellectual developmental disorders (severe intellectual disability); 3. Neurological diseases: stroke, epilepsy, brain tumors, Parkinson's disease, Alzheimer's disease, multiple sclerosis, etc.; 4. Severe systemic medical diseases: autoimmune diseases, psoriasis, systemic lupus erythematosus, inflammatory bowel disease, rheumatoid arthritis, type 1 diabetes mellitus, chronic obstructive pulmonary disease, malignant tumors, etc.; 5. Pregnant or lactating women; 6. History of severe allergic reaction within the recent 1 month; 7. History of infection within the recent 3 months; minor cold: within 2 weeks; influenza: within 3 weeks; severe pneumonia: within 3 months; 8. Receiving immunosuppressive or immunomodulatory therapy, including glucocorticoids; 9. Administration of therapeutic doses of antioxidants or omega-3 supplements within the recent 3 months (fish oil intake >2 g/day); 10. Surgical history within the recent 3 months; 11. Frequent use of analgesic drugs; 1–2 doses within 1 week: excluded; 1–2 doses within 2 weeks: excluded; 12. Other diseases causing secondary insomnia (excluding depression): obstructive sleep apnea-hypopnea syndrome (defined as >=30 episodes of apnea and hypopnea during 7 hours of sleep per night, or apnea-hypopnea index >=5 events/hour), somatic diseases, drug abuse, etc.; 13. History of alcohol abuse, drug abuse or psychoactive substance use; 14. Patients with potential allergy to anesthetics: known allergy to eggs, soybean products, opioids and their antidotes, propofol, etc.; contraindications to propofol, opioids and their antidotes; 15. BMI 28, or baseline blood pressure 3; 17. Inability to complete psychological assessments; 18. Refusal to participate by the subject or legal guardian.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index Scale;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Polysomnography; | — |
Countries
China
Contacts
Public ContactLi Jing.Li Manwei
Sichuan Provincial People's Hospital, Sichuan Provincial Mental Health Center
Outcome results
None listed