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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06376760
Eligibility Criteria:
Inclusion Criteria:
* Patients with insomnia:
1. Age of 18 - 64 years;
2. ASA physical status of I - II;
3. BMI of 15 - 30;
4. Scheduled for digestive endoscopy under intravenous anesthesia;
5. Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder;
6. 8-item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less;
* Patients with normal sleep:
1. Age of 18 - 64 years;
2. ASA physical status of I - II;
3. BMI of 15 - 30;
4. Scheduled for digestive endoscopy under intravenous anesthesia;
5. No history or evidence of insomnia.
Exclusion Criteria:
* 1\. Associated with any neurological disease; 2. Daily alcohol consumption; 3. Any contraindication to intravenous anesthetic drug, such as hypotension or shock; 4. History of allergy to any drug used in the study; 5. Pregnancy or breastfeeding; 6. Patients with sleep apnea syndrome; 7. acute upper respiratory infection; 8. Patients with psychological diseases who report suicidal thoughts; 9. Patients who need to work or take care of children/elderly people frequently at night.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT06376760
Study Brief:
Protocol Section:
NCT06376760