Primary insomnia or emotional disorders accompanied by insomnia symptoms
Conditions
Interventions
Dimdazenil group:Take medication at least 3 times a week
Midazolam group:Take medication at least 3 times a week
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged =18 and =65 years, of either gender; 2) A total sleep time of less than 6 hours accompanied by depressive episodes or bipolar disorder, or primary insomnia patients with a total sleep time of less than 6 hours; 3) Guarantee at least 7 hours of sleep time; 4) Have the behavioral capacity to read and complete scales and sleep diaries; 5) Voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Contraindications to Dimdazenil include allergies to any excipients of Dimdazenil, severe obstructive sleep apnea (OSA), respiratory dysfunction, or myasthenia gravis; 2) Contraindications to midazolam include allergies to any of its components, myasthenia gravis, severe cardiopulmonary dysfunction, severe liver dysfunction, or sleep apnea syndrome. 3) Patients exhibiting independent judgment, cognitive function, intellectual capacity, and behavioral abnormalities, which researchers have assessed as potentially influencing scale assessments and sleep diary completion; 4) According to the ICD-10 diagnostic criteria, the diagnosis is for other mental illnesses except for insomnia, depression, and bipolar disorder; 5) Individuals who currently have unstable physical illnesses or may compromise the safety of the trial, and are deemed unsuitable for participation by the researcher; 6) Women who are pregnant or breastfeeding; 7) Conditions that the researcher deems unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjectively recorded total sleep time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function assessment;Sleep efficiency;Sleep Awakening Time;Insomnia Severity Index;tired;Assessment of daytime attention and working memory function;Subjectively sleep latency;Somnolence;Sleep awakening frequency;EQ-5D-5L; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital Affiliated to Capital Medical University
Outcome results
None listed