Insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. According to the 3rd edition of the Chinese Diagnostic Classification of Mental Disorders, insomnia was diagnosed; 2. Age range: 18 to 60 years old; 3. Self-assessment score of the Sleep Rating Scale (SRSS) > 23 points; 4. Normal cognitive function; 5. No use of any drugs related to sleep; 6. No neurological diseases that affect the collection of brain signals (such as epilepsy, history of brain trauma or neurodegenerative diseases), to ensure the accuracy and safety of the brain-computer interface equipment; 7. Complete scalp, without skin lesions or wounds, facilitating the placement of electrodes and signal transmission of portable electroencephalography equipment; 8. Able to understand and independently or under guidance correctly wear and use portable electroencephalography equipment, which is a basic requirement for brain-computer interface monitoring.
Exclusion criteria
Exclusion criteria: 1. Individuals with olfactory disorders or loss of smell; 2. Patients with other sleep disorders such as sleep apnea-hypopnea syndrome, restless legs syndrome, etc. 3. Those with allergies to pollen or drugs; 4. Patients with serious physical or mental disorders that are directly related to insomnia; 5. Pregnant and lactating women; 6. Individuals with a history of neurological diseases, including epilepsy, family history of epilepsy, migraines, brain trauma or unexplained loss of consciousness, to avoid interference of brain-computer interface device signals or safety risks; 7. Those with implanted cardiac pacemakers, intracranial metal implants or other electronic implants that may affect brain electrical signals; 8. Those who cannot understand the research protocol or cannot provide informed consent; 9. Those with known allergies to electrode materials, adhesives or related accessories to ensure the safe use of brain-computer interface devices; 10. Those with current or past mental illness history, which may affect the interpretation of brain-computer interface data or trial compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep latency;(Percentage of (S3 + S4) / Proportion of deep sleep);Actual sleep time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI);Pittsburgh Sleep Quality Index (PSQI); | — |
Countries
China
Contacts
The First Hospital Of Jiaxing