Study for Evaluating the Efficacy of Ciprofol in Patients Under Narcotic Sleep With Chronic Insomnia

A Single Center, Randomized, Single Blind, Exploratory Study for Evaluating the Efficacy of Ciprofol in Patients Under Narcotic Sleep With Chronic Insomnia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Drug: ciprofol; Drug: medium/long chain fat emulsion injection (C8-24Ve)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan, China
    • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female aged 18 (inclusive) to 70 (inclusive) years old;
2. ASA class of I-II;
3. 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;

4. Compliant with the diagnostic criteria of ICSD-3 chronic insomnia:

   1. At least one of the following chief complaints: initial insomnia, difficulty in sleep maintenance, early awakening, refusal to go to bed at an appropriate time, and difficulty in falling asleep without nursing;
   2. At least one of the following daytime symptoms: tiredness, short tempered, work/study/social skills decreased;
   3. Occurrence of the above symptoms at least 3 times per week and lasting for more than 3 months;
5. Voluntarily adopt narcotic sleep and obtain the written informed consent form.

Exclusion Criteria:

1. With contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
2. With a history of allergy or contraindications to anesthetics;

3. With a medical history or evidence of any of the followings before screening/at baseline, which may increase sedation/anesthesia risks:

   1. History of cardiovascular diseases: uncontrolled hypertension [systolic blood pressure (SBP) ≥ 170 mmHg and/or diastolic blood pressure (DBP) ≥ 105 mmHg without treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite antihypertensive treatment], severe arrhythmia, heart failure, Adams-stokes syndrome, New York Heart Association (NYHA) Class ≥ III, severe superior vena cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medical treatment, II-III degree atrioventricular block (excluding patients with pacemakers);
   2. History of respiratory system disorders: respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months before screening, and acute respiratory tract infection with obvious symptoms such as fever, wheezing, nasal obstruction, and cough within 1 week before baseline;
   3. History of neurological and psychiatric disorders: craniocerebral injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents; schizophrenia, mania, insanity, history of cognitive disorder; history of epilepsy; mental disorder suggested by Mini International Neuropsychiatric Interview (MINI);
   4. History of gastrointestinal disorders: gastrointestinal retention, active hemorrhage, or conditions that may lead to reflux and aspiration;
   5. History of blood donation or blood loss of ≥ 400 mL within 3 months before screening;

4. With the following airway management risks at screening:

   1. History of asthma or stridor;
   2. Sleep apnea syndrome;
   3. History or family history of malignant hyperthermia;
   4. History of tracheal intubation failure;
   5. Judged by investigators to have difficult airway or judged as difficult tracheal intubation (modified Mallampati class IV) at screening;

5. Receipt of any of the following medications/therapies at screening/baseline:

   1. Any clinical study within 1 month before screening;
   2. Sedatives/anesthetics, and/or sedative-hypnotics within 72 h before baseline;
   3. Antidepressants and anxiolytics within 14 days before baseline;

6. Laboratory test abnormalities at screening:

   1. Total bilirubin > 2 × ULN (upper limit of normal);
   2. Aspartate aminotransferase (AST) and alanine transaminase (ALT) > 2 × ULN;
   3. Blood creatinine > 1.5 × ULN;
7. Unable to fast for 6 h before dose administration;
8. 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);
9. 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);
10. Unable to avoid engaging in dangerous occupations requiring concentration and/or motor coordination 72 h after administration;
11. Judged by investigators to be unsuitable for participating in this trial for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: medium/long chain fat emulsion injection (C8-24Ve); at the infusion rate of 25-30 mL/h
Experimental: Ciprofol	Drug: ciprofol; intravenous infusion of ciprofol at 0.12 mg/kg, followed by 0.4-1.6 mg/kg/h for maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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）	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

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: HSK3486-IIT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No