Chronic Insomnia Disorder
Conditions
Interventions
Sponsors
The Affiliated Hospital of Traditional Chinese Medicine of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Chronic Insomnia Disorder (CID) Patients: 1. Meet the diagnostic criteria for chronic insomnia in the International Classification of Sleep Disorders (3rd Edition) (ICSD-3), including:At least one of the following sleep symptoms: difficulty falling asleep, difficulty maintaining sleep, early-morning awakening.At least one of the following daytime symptoms related to nighttime sleep difficulties: daytime fatigue or drowsiness, impaired attention or memory, emotional instability or irritability, lack of energy, dissatisfaction with sleep.Difficulty falling asleep cannot be solely explained by insufficient sleep opportunity (e.g., adequate sleep duration) or poor sleep environment (e.g., dark, safe, quiet, and comfortable environment). Sleep disturbance and related daytime symptoms occur at least 3 times per week for at least 3 months.Sleep difficulties cannot be better explained by another sleep disorder. 2. Right-handed, aged 18–70 years. 3. Pittsburgh Sleep Quality Index (PSQI) score >=7, Insomnia Severity Index (ISI) score >=14, Self-Rating Anxiety Scale (SAS) standard score >=70, Self-Rating Depression Scale (SDS) standard score >=73. 4. Able to complete relevant rating scales, voluntarily participate in the study, and sign the informed consent form. Healthy Subjects: 1. Right-handed, aged 18–70 years. 2. No personal or family history of neuropsychiatric diseases; personal mental and neurological diseases excluded via mental health screening scales and neurosis screening scales. 3. Insomnia excluded via sleep scales before enrollment. 4. Able to complete relevant rating scales, voluntarily participate in the study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Chronic Insomnia Disorder (CID) Patients (Exclusion Criteria): 1. History of intracranial organic lesions, craniotomy, or severe head trauma. 2. Comorbid other mental disorders, or severe systemic diseases (e.g., cardiovascular, hepatic, renal disorders). 3. Current use of anticholinergics, non-steroidal anti-inflammatory drugs (NSAIDs), hormones, or medications that inhibit brain neural activity (e.g., antipsychotics). 4. History of alcohol abuse or drug dependence. 5. Contraindications to magnetic resonance imaging (MRI), such as implanted insulin pumps or pacemakers. 6. Allergy to skin preparation, or injuries/inflammation at the stimulation site. 7. Pregnant or lactating women. 8. Participation in other clinical trials within the past 6 months. Healthy Subjects (Exclusion Criteria): 1. Contraindications to magnetic resonance imaging (MRI). 2. History of alcohol abuse or drug dependence. 3. Allergy to skin preparation, or injuries/inflammation at the stimulation site. 4. Pregnant or lactating women. 5. Participation in other clinical trials within the past 6 months.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index, ISI;Epworth sleep scale, ESS;Self-Rating Depression Scale, SDS;self-rating anxiety scale, SAS;SF-36;COMPASS-31;Mini-mental state examination, MMSE;Functional magnetic resonance imaging index (ALFF/fALFF/ReHo/FC/DTI/ASL/ICA/complex networks/SVM/brain structure index, etc.);Heart rate variability, HRV; | — |
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, PSQI; | — |
Countries
China
Contacts
Public ContactFeng Menghan
The Affiliated Hospital of Traditional Chinese Medicine of Guangzhou Medical University
Outcome results
None listed