Insomnia
Conditions
Interventions
Control group:Estazolam Tablets
Research Group:Dimdazenil Capsules
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age = 18 years and = 65 years old, gender not restricted; 2.Meets the diagnostic criteria for insomnia disorder as defined in the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), with complaints of dissatisfaction with sleep quantity or quality (including difficulty falling asleep, maintaining sleep, or waking up early and being unable to fall back asleep), causing distress or functional impairment, occurring at least 3 nights a week for more than 3 months, despite having sufficient sleep opportunities, and being unable to fall asleep easily and cannot be fully explained by other sleep-wake disorders, substance physiological effects, coexisting mental disorders, or physical diseases; 3.Not taking medication or taking sedative-hypnotic drugs other than those used in the study, accompanied by daytime functional impairment or painful experiences (drowsiness, fatigue, cognitive difficulties, difficulty concentrating, etc., one or more subjective discomfort sensations); 4.Can ensure at least 7 hours of sleep time; 5.Has the ability to read and fill out the sleep diary; 6.Has fully understood this study and voluntarily signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Anyone allergic to any excipients in Dimdazenil Capsules or Estazolam Tablets; 2.Those with obstructive sleep apnea (OSA), respiratory dysfunction or myasthenia gravis, or those with a previous history of any of these conditions; 3.GAD-7 score = 15 points or PHQ-9 score = 20 points; 4.Those with severe mental disorders; 5.Chronic pain patients; 6.Insomnia patients with severe organic diseases, clinical manifestations or history of liver or kidney damage; 7.Pregnant or lactating women; 8.Those currently participating in other clinical trials; 9.Other situations that the researcher deems unsuitable for participation in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in fatigue assessment (using the Flinders Fatigue Scale) score after 14 days of treatment compared to the baseline level; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the Epworth Sleepiness Scale score after 14 days of treatment compared to the baseline level;The change in subjective sleep latency (sSL) compared to the baseline after 14 days of treatment;The change in subjective total sleep time (sTST) compared to the baseline after 14 days of treatment;The changes in subjective sleep-wake time (sWASO) compared to the baseline after 14 days of treatment;The change in subjective sleep efficiency (sSE) compared to the baseline after 14 days of treatment;The changes in subjective sleep-wake frequency (sNAW) compared to the baseline after 14 days of treatment;The changes in insomnia severity (score on ISI scale) compared to the baseline after 14 days of treatment.;The change in the daytime functional factor score of the ISI scale (the total score of questions 3, 4, and 5) after 14 days of treatment compared to the baseline;The changes in the daytime attention and working memory function assessment (Digit Symbol Substitution Test (DSST)) scores after 14 days of treatment compared to the baseline;The change in cognitive function assessment (the Trail Making Test - Part A - TMT-A) score after 14 days of treatment compared to the baseline score; | — |
Countries
China
Contacts
Public ContactJinsheng Zeng
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed