Patients with chronic insomnia disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 18–65 years, regardless of gender; 2) Meet the diagnostic criteria of ICSD-3 and DSM-5; 3) 7 < PSQI < 21, with HAMA score < 14 and/or HAMD score < 17; 4) No use of any psychotropic medications in the past month; 5) No acupuncture intervention received in the past month; 6) No fear of acupuncture and able to cooperate with the entire experimental procedure; 7) Willing to participate in the study, accept random grouping, and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Sleep disorders attributed to major depression, anxiety disorders, schizophrenia, or other severe mental illnesses, with HAMA score > 14 and/or HAMD score > 17; 2) Accompanied by severe or unstable cardiovascular, respiratory, hepatic, renal, hematological, or other systemic diseases, or those with comorbid organic brain disorders; 3) Other sleep disorders, or if any other sleep disorder is identified, such as obstructive sleep apnea, rapid eye movement (REM) sleep behavior disorder, or restless legs syndrome; 4) Conditions unsuitable for acupuncture treatment, such as pregnancy or lactation; 5) Individuals who have received acupuncture treatment for chronic insomnia within the past month; 6) Individuals with alcohol and/or other substance abuse or dependence; 7) Patients unable to cooperate with EEG monitoring or with contraindications for EEG (e.g., metal implants, pregnancy, and history of epilepsy); 8) Local skin damage, infection, or keloid predisposition at the acupoint sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difficulties in Emotion Regulation Scale (DERS);Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS);Fatigue Scale (FFS);Thought Control Ability Questionnaire (TCAQ);17-Item Hamilton Depression Rating Scale (HAMD-17) score;14-Item Hamilton Anxiety Rating Scale (HAMA-14) Score;Electroencephalogram (EEG); Electrocardiogram (ECG);Negative Cognitive Processing Bias Questionnaire (NCPBQ); | — |
Countries
China
Contacts
Jiangsu Province Hospital of Chinese Medicine