chronic insomnia
Conditions
Interventions
eszopiclene group:estazolam
Sponsors
The First Affiliated Hospital of Guangdong Pharmaceutical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1). Chronic insomnia refers to the Chinese Guidelines for the Diagnosis and Treatment of Insomnia in Adults, 2017 edition, and must meet the criteria ?-? at the same time ? Presence of one or more of the following symptoms of sleep abnormality (self-reported by the patient or observed by the caregiver): (1) difficulty in falling asleep; (2) difficulty in maintaining sleep; (3) waking up earlier than desired wake-up time; and (4) unwillingness to go to bed at the appropriate time. (ii) Presence of one or more of the following daytime symptoms associated with insomnia (self-reported by the patient, or observed by a caregiver): (1) fatigue or general malaise; (2) difficulty concentrating or remembering; (3) impairment of social, family, occupational, or academic functioning; (4) irritability or agitation; (5) daytime sleepiness; (6) behavioral problems (e.g., hyperactivity, impulsivity, or aggressiveness); (7) Decreased energy and stamina; (8) Susceptibility to errors and accidents; and (9) Excessive preoccupation with sleep problems or dissatisfaction with sleep quality. (iii) Sleep abnormality symptoms and related daytime symptoms cannot be explained solely by the absence of an appropriate sleep schedule or an inappropriate sleep environment. (iv) Sleep abnormality symptoms and related daytime symptoms occur at least 3 times per week. ? Sleep abnormality symptoms and related daytime symptoms persist for at least 3 months. ? Difficulties with sleep and arousal cannot be better explained by other types of sleep disorders. 2) Any gender, age =18 years. 3) Can understand the content of the scale and actively cooperate with the treatment. 4) Agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Those who fulfill any of the following are not included for clinical observation: ? Those with sleep disorders caused by mental disorders, somatic diseases, drug or substance abuse, such as respiratory-related sleep disorders, restless legs syndrome, periodic limb movement disorders, circadian rhythm dysregulation sleep-wake disorders, persistent pain, malignant tumors, insomnia caused by stroke; ? Those with clinically diagnosed abnormal liver or kidney function, or those with aminotransferase AST or ALT greater than two times the upper limit of normal, and blood creatinine or blood urea nitrogen greater than the upper limit of normal; ? Those who have undergone surgery within 3 months, or those who are expected to undergo surgical treatment within 1 month; ? Those who have other serious diseases that lead to poor prognosis or reduced survival, such as acute infections, sepsis, malignant tumors, diseases of other important organs, other serious uncontrolled diseases of various systems; ? Females of childbearing age who have experienced pregnancy or are breastfeeding and are not using adequate contraception; ? Those who are allergic to the test drug or related ingredients; 7) Those who have participated in other clinical trials within the last 1 month; 8) Any other medical condition that, in the opinion of the investigator, may place the patient at risk or affect the results of the study, or that, in the opinion of the investigator, exists that is not appropriate for the study, including due to drug or alcohol abuse or psychiatric disorders, that would interfere with the patient's ability to comply with the protocol or follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| 7 Factors of PSQI;Insomnia severity index;Hamilton Anxiety Scale;Hamilton Depression Scale;TCM Syndrome Scale of Glycolipid Metabolism;blood glucose;Blood lipid;blood pressure;Data from Actigraphy; IL-6;TNF-a;Serum specimen metabolomics full-spectrum detection; | — |
Countries
China
Contacts
Public ContactGuo Jiao
The First Affiliated Hospital of Guangdong Pharmaceutical University
Outcome results
None listed