Insomnia
Conditions
Interventions
Intervention Group:On the basis of CBT-I combined with stellate ganglion block (SGB) therapy, participants in the intervention group will additionally receive ciprofol therapy for one treatment course
Control Group:The treatment will be conducted using CBT-I combined with stellate ganglion block (SGB) therapy. Participants will complete one session of CBT-I on Day 1, Day 7, and Day 14, either onlin
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-60 years. (2) Informed Consent: The participant or their legal guardian must provide written informed consent. (3) Diagnosis: The participant must meet the diagnostic criteria for insomnia disorder according to the ICD-11 (International Classification of Diseases, 11th Revision). (4) Duration of Insomnia: The participant must have a history of insomnia disorder lasting for at least 3 months. (5) Severity of Insomnia: Participants must have a moderate to severe chronic insomnia, as determined by an Insomnia Severity Index (ISI) score of 15 or higher. (6) Normal Coagulation Function: The participant must have normal coagulation function, with no infection at the puncture site.
Exclusion criteria
Exclusion criteria: (1) Other Axis-I Psychiatric Disorders: Including but not limited to depression, bipolar disorder, schizophrenia, schizoaffective disorder, organic mental disorders, substance use disorders (except nicotine dependence), and autism spectrum disorders. (2) Axis-II Psychiatric Disorders: Including personality disorders (e.g., borderline personality disorder, antisocial personality disorder) and intellectual developmental disorders (e.g., severe intellectual disability). (3) Neurological Diseases: Such as stroke, epilepsy, brain tumors, multiple sclerosis, etc. (4) Major Medical Diseases: Including autoimmune diseases, psoriasis, systemic lupus erythematosus, inflammatory bowel diseases, rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), cancer, etc. (5) Pregnant or Lactating Women. (6) Severe Allergic Reactions within the past month. (7) Infection History within the past month (e.g., common cold within 2 weeks; influenza within 3 weeks). (8) Other Conditions Leading to Secondary Insomnia: Including obstructive sleep apnea-hypoventilation syndrome (defined as more than 30 episodes of apnea and hypoventilation during 7 hours of sleep, or apnea-hypoventilation index =5 events/hour), somatic diseases, substance abuse, etc. (9) History of Alcohol, Drug Abuse, or Psychoactive Substance Use. (10) Patients with ASA Class III or Higher Insomnia. (11) Allergy to Soy or Peanuts, or allergy to ciprofol or its excipients. (12) Contraindications for Stellate Ganglion Block (SGB): Including coagulation disorders, local skin infections, recent history of myocardial infarction, glaucoma, thyroid enlargement, cardiac conduction abnormalities, and patients who are non-compliant due to psychiatric disorders. (13) Refusal to Participate by the participant or their legal guardian.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index ;Depression Screening ;Generalized Anxiety Disorder ;Epworth Sleepiness ;Polysomnography (PSG) data;Heart Rate Variability (HRV);Cortisol (at 8:00 a.m. or 1–2 hours after waking);Melatonin (morning urine);Inflammatory marker: Interleukin-6 (IL-6); | — |
Countries
China
Contacts
Public ContactZhao Lei
Shenzhen People’s Hospital
Outcome results
None listed