Insomnia disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient group inclusion criteria (only those who meet all of the following criteria can be enrolled) : 1.1. Aged 18-80 years old; 1.2. Right-handed; 1.3. meet the diagnostic criteria for insomnia disorder in the DSM-5; A. The chief complaint is dissatisfaction with the length or quality of sleep, accompanied by one (or more) of the following related symptoms: 1. Difficulty falling asleep; 2. Difficulty maintaining sleep, which is characterized by frequent awakenings or difficulty falling back to sleep after waking up; 3. Wake up early and can't fall back asleep; B. Sleep disturbances cause clinically significant distress or impairment of social, occupational, educational, learning, behavioral, or other important functions; C. Difficulty sleeping at least 3 nights per week; D. Difficulty sleeping for at least 3 months; E. Difficulty sleeping despite adequate sleep opportunities; F. Insomnia is not better explained by another sleep-wake disorder, nor does it occur only in the course of another sleep-wake disorder; G. Insomnia cannot be attributed to the physiological effects of a substance (e.g., abused drugs, medications); H. Co-existing mental and physical disorders do not adequately explain the insomnia complaint; 1.4.PSQI total score >5,ISI score >8; 1.5. Do not take benzodiazepine and non-benzodiazepine hypnotic drugs at least 2 weeks before the start of the experiment; 1.6. Consent to birth control during the study period (for female patients aged 18-50 years); 1.7. Agree not to receive benzodiazepine and non-benzodiazepine hypnotic drugs or other physical therapy to improve sleep (transcranial direct current, transcranial light regulation, etc.) throughout the trial period; 1.8. Obtain the informed consent signed by the patient, and the compliance is good; 2. Inclusion criteria of control group: 2.1. Aged 18-80 years old; 2.2. No symptoms or history of mental disorders and sleep disorders; 2.3. Total score of PSQI is less than or equal to 5; 2.4. Have not taken psychotropic drugs or hypnotic drugs; 2.5. Sign informed consent;
Exclusion criteria
Exclusion criteria: (a) suffering from a serious medical disease; 3.2 Patients with schizophrenia, schizoaffective disorder, persistent delusional disorder (paranoid psychosis), bipolar disorder, mental disorders caused by epilepsy, mental disorders accompanied by mental retardation, organic mental disorders; 3.3. Patients with major depressive disorder and suicidal tendencies; 3.4. Patients suffering from sleep disorders other than insomnia disorders (such as sleep apnea, restless leg syndrome, etc.); 3.5. Patients with frequent jet lag; 3.6. Patients with BMI>30; 3.4. Patients who have received physical therapy such as electroshock, transcranial magnetic stimulation or transcranial electrical stimulation within the last 3 months; 3.5. Patients with cochlear implants, cardiac pacemakers, or metal implants in the brain; 3.6. Have a history of epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting-state electroencephalogram (EEG);polysomnography (PSG);Multimodal MRI scanning;Pittsburgh Sleep Quality Index;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory;Beck Anxiety Inventory;Mini-Mental State Examination;Montreal Cognitive Assessment Scale; | — |
Countries
China
Contacts
School of Life Science and Technology, Xidian University; The Second Hospital of Hebei Medical University