Chronic moderate to severe insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of ICSD-3 chronic insomnia; (2) 18-65 years old; (3) ISI score =15; (4) People who have taken two or more drugs to improve sleep in the past, but are still not satisfied with the current treatment; (5) Good compliance, willing to accept this therapy.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women; (2) Chronic insomnia that can be explained by the primary disease; (3) Medical history or psychiatric disorders that the investigator considers to affect the safety of the subjects or interfere with the study evaluation; (4) Abnormal electrocardiogram; (5) Planned or unplanned suicidal thoughts at the time of screening or within 6 months after screening; Or have attempted suicide in the past 10 years; (6) Clinically significant diseases (e.g., cardiovascular diseases; Respiratory diseases; Digestive system diseases; Liver function damage; Kidney disease; Nervous system diseases; Endocrine system diseases; Infectious diseases; Mental illness; History of malignancy) or chronic pain that the investigators felt might affect the safety of the subjects or interfere with the study's assessment. Subjects whose sedatives were contraindicated for safety reasons due to their occupation or activity were also excluded. (7) Currently diagnosed sleep-related breathing disorders included obstructive apnea, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder or narcolepsy; (8) Patients were lost to follow-up due to various reasons, patients withdrew from the follow-up due to other random reasons; (9) Patients with a history of alcoholism or excessive consumption of coffee or strong tea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia severity index;Hamilton Anxiety Scale;Hamilton Depression Scale; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Air Force Medical University