Chronic insomnia
Conditions
Interventions
Control group:Standard CBT-I, a total of 6 treatments
Experimental group:HC-CBT-I, based on the standard CBT-I, adds approximately 15 minutes each time. The N1 suggestive intervention module induced by low-dose dexmedetomidine (that is, on the basis of t
Sponsors
Xiangcheng People's Hospital of Suzhou City
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Those meeting all of the following criteria can be enrolled: 1. Meet the diagnostic criteria for insomnia disorder as defined in the DSM-5, confirmed by a clinical physician (symptoms >= 3 nights/week and disease duration >= 3 months, accompanied by daytime functional impairment); 2. Age 18–65 years old, gender not limited; 3. Total score of the Insomnia Severity Index (ISI) >= 15 points; 4. Have been using 1–2 types of sedative-hypnotic drugs or sleep aids for >= 3 months, and have used the stable dosage (>= 5 nights/week) before randomization; 5. Have the cognitive and language abilities to complete cognitive behavioral therapy and follow-up assessment; 6. Voluntarily participate in this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: The following conditions disqualify an individual from being included in the study: 1. Confirmed obstructive sleep apnea (OSA); 2. Having alcohol or substance use disorder within the past 12 months, including abuse of benzodiazepines or opioids; 3. Organic brain disease or intellectual/learning disorder that affects informed consent or intervention compliance; 4. Currently undergoing systematic individual CBT/CBT-I, or having received structured CBT-I within 8 weeks; 5. Severe or unstable internal medical conditions that affect the intervention or safety (such as decompensated heart disease, active malignant tumors, advanced renal failure, etc.); 6. Major neurological diseases (such as neurodegenerative disorders, recent stroke, etc.); 7. Schizophrenia, bipolar disorder in acute phase, or acute high suicide risk; 8. Pregnant or lactating, or planning to become pregnant during the study period; 9. Severe cognitive impairment, unable to complete treatment tasks or follow-up assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia severity index;Sleep diary; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Hospital Anxiety and Depression Scale;Dosage of hypnotic drugs and reduction time;Treatment satisfaction; | — |
Countries
China
Contacts
Public ContactLi Yan
Xiangcheng People's Hospital of Suzhou City
Outcome results
None listed