Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT06212934
Eligibility Criteria:
Inclusion Criteria:
1. Meet diagnostic criteria for short-term insomnia according to the Diagnostic and Statistical Manual of Mental Disorders Text Revision, 5th ed (DSM-V) and Chinese Adult Insomnia Diagnosis and Treatment Guide 2017，a predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms: 1)Difficulty initiating sleep. 2). Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. 3)Early-morning awakening with inability to return to sleep. 4)The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. The sleep difficulty occurs at least 3 nights per week. The duration of the sleep difficulty is 1 week to 3 months.
2. Experienced insomnia between 1 weeks and 3 months before the start of project.
3. Age: patients between 18 and 70 years old.
4. Patients who agreed to participant in this trial and assigned the informed consent.
Exclusion Criteria:
1. People with other DSM-IV Axis I, Axis II mental disorders or substance abuse/dependence;
2. Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, hypertension, digestive system, hematopoietic system, liver, kidney, or severe anxiety and depression;
3. Caused by alcohol or drugs;
4. Pregnant or lactating women;
5. Easy to combine infection and bleeding; 6.1 Patients who have used psychotropic drugs, such as antidepressants, mania drugs or other drugs used to treat psychosis, in the last month, and patients who have taken sleeping pills in the last 1 month;
7\. Those who cannot cooperate with treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06212934
Study Brief:
Protocol Section:
NCT06212934