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This is a single center, randomized, single blind, exploratory clinical study.About 30 patients with chronic insomnia are planned to be enrolled in this study and randomized into two groups by a ratio of 4:1 (Figure 1), with group 1 (24 subjects) for ciprofol and group 2 (6 subjects) for placebo (fat emulsion). Cognitive behavioral therapy (CBT) will be given to these patients during the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ciprofol | Drug | intravenous infusion of ciprofol at 0.12 mg/kg, followed by 0.4-1.6 mg/kg/h for maintenance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography (PSG) | total sleep time (TST) | Day -2 to Day 90 |
| Polysomnography (PSG) | sleep latency (SL) | Day -2 to Day 90 |
| Polysomnography (PSG) | wake after sleep onset (WASO) | Day -2 to Day 90 |
| Sleep log | subjective total sleep time (sTST) | Day -2 to Day 90 |
| Sleep log | subjective sleep-onset latency (sSOL) | Day -2 to Day 90 |
| Sleep log | subjective wake after sleep onset (sWASO) | Day -2 to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-rating scales | Pittsburgh Sleep Quality Index (PSQI)(0-21) | Day -2 to Day 90 |
| Self-rating scales | Insomnia Severity Index (ISI)(0-28) |
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Inclusion Criteria:
Male or female aged 18 (inclusive) to 70 (inclusive) years old;
ASA class of I-II;
With chronic insomnia refractory to conventional drugs in the past 3 months (benzodiazepine receptor agonists and other drugs). Other drugs: melatonin, melatonin receptor agonists, and traditional Chinese medicine;
Compliant with the diagnostic criteria of ICSD-3 chronic insomnia:
Voluntarily adopt narcotic sleep and obtain the written informed consent form.
Exclusion Criteria:
With contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
With a history of allergy or contraindications to anesthetics;
With a medical history or evidence of any of the followings before screening/at baseline, which may increase sedation/anesthesia risks:
With the following airway management risks at screening:
Receipt of any of the following medications/therapies at screening/baseline:
Laboratory test abnormalities at screening:
Unable to fast for 6 h before dose administration;
With a history of smoking, drug abuse and/or positive urine drug screening results, or positive breath alcohol test results at baseline and/or a history of alcohol abuse within 3 months before screening. Alcohol abuse is defined as an average of > 2 units of alcohol consumed per day (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol, or 150 mL of wine);
Pregnant or breastfeeding females; women of child-bearing potential or men who are unwilling to use contraception during the trial; or patients who are planning pregnancy within 1 month after the trial (including male patients);
Unable to avoid engaging in dangerous occupations requiring concentration and/or motor coordination 72 h after administration;
Judged by investigators to be unsuitable for participating in this trial for any reason.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Sichuan | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
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| medium/long chain fat emulsion injection (C8-24Ve) | Drug | at the infusion rate of 25-30 mL/h |
|
| Day -2 to Day 90 |
| Self-rating scales | PHQ-9 Depression Test Questionnaire(0-27) | Day -2 to Day 90 |
| Self-rating scales | GAD-7 Anxiety Test Questionnaire(0-21) | Day -2 to Day 90 |
| Self-rating scales | Epworth Somnolence Scale(0-24); | Day -2 to Day 90 |
| D001523 |
| Mental Disorders |