Chronic insomnia accompanied by anxiety and/or depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Chronic insomnia lasting more than 2 years, recurrent, and not improved after treatment with two or more different types of medications (treatment-resistant insomnia disorder, also known as refractory insomnia disorder), diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5); 2. Age over 18 years, male or female; 3. Patients with moderate to severe insomnia, with insomnia severity index (ISI) >= 15; 4. Pittsburgh Sleep Quality Index (PSQI) total score > 7; 5. Accompanied by anxiety and/or depressive states: 14-item Hamilton Anxiety Scale (HAMA) >= 14; 24-item Hamilton Depression Scale (HAMD-24) >= 21; 6. Voluntarily participating in this treatment and having signed the clinical informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals allergic to propofol; 2. Those with cardiac conduction block, severe ventricular dysfunction, severe liver or kidney dysfunction, or other serious physical illnesses; 3. Those with abnormal blood pressure, bradycardia, or poorly controlled blood sugar in diabetes; 4. Those with sleep apnea before treatment; 5. Individuals with a history of head trauma; 6. Those with a history of epilepsy, psychiatric disorders, or abnormal EEG findings; 7. Individuals with a history of alcohol or drug abuse; those who are pregnant, breastfeeding, or planning pregnancy; 8. Those with MRI contraindications, including claustrophobia or metal implants in the body; 9. Individuals with an education level below elementary school or unable to understand the content of pre- and post-treatment assessment scales.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Real-time EEG detection of changes in brain activity during propofol treatment in the prefrontal cortex;Nighttime raw EEG before and after treatment;Pittsburgh Sleep Quality Index score; | — |
Countries
China
Contacts
Liaocheng People's Hospital