chronic insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria of DSM-V insomnia; 2) Age 18-65 years old; 3) Significant daytime dysfunction (i.e. ISI item 5 [daytime dysfunction] = 3); 4) Insomnia Severity Index Scale (ISI) = 15 points; 5) The patient or family members signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with severe depressive symptoms, Patient Health Questionnaire-9 (PHQ-9) = 20; 2) Patients with severe anxiety symptoms, Generalized Anxiety Scale-7 (GAD-7) = 15; 3) Combined with severe mental illness, such as manic episodes, schizophrenia; 4) Imminent suicide risk, Item 9 of Patient Health Questionnaire-9 (PHQ-9) = 2 points; 5) Patients with severe hearing impairment; 6) Patients with severe tinnitus; 7) Unsupervised or unable to take medicine as prescribed by a doctor; 8) Those who have received other clinical trials for the treatment of insomnia within 3 months; 9) Alcohol or drug dependence within one year; 10) Continuous use of benzodiazepine sedative and hypnotic drugs for the past two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index Scale (ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire-9 (PHQ-9);Pittsburgh Sleep Quality Index (PSQI);Generalized Anxiety Scale (GAD-7); | — |
Countries
China