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

Chronic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04958382
• Other study ID #: HSK3486-IIT-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Sichuan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• ciprofol
intravenous infusion of ciprofol at 0.12 mg/kg, followed by 0.4-1.6 mg/kg/h for maintenance
• medium/long chain fat emulsion injection (C8-24Ve)
at the infusion rate of 25-30 mL/h

Locations

Country	Name	City	State
China	Sichuan Provincial People's Hospital	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography (PSG)	total sleep time (TST)	Day -2 to Day 90
Primary	Polysomnography (PSG)	sleep latency (SL)	Day -2 to Day 90
Primary	Polysomnography (PSG)	wake after sleep onset (WASO)	Day -2 to Day 90
Primary	Sleep log	subjective total sleep time (sTST)	Day -2 to Day 90
Primary	Sleep log	subjective sleep-onset latency (sSOL)	Day -2 to Day 90
Primary	Sleep log	subjective wake after sleep onset (sWASO)	Day -2 to Day 90
Secondary	Self-rating scales	Pittsburgh Sleep Quality Index (PSQI)(0-21)	Day -2 to Day 90
Secondary	Self-rating scales	Insomnia Severity Index (ISI)(0-28)	Day -2 to Day 90
Secondary	Self-rating scales	PHQ-9 Depression Test Questionnaire(0-27)	Day -2 to Day 90
Secondary	Self-rating scales	GAD-7 Anxiety Test Questionnaire(0-21)	Day -2 to Day 90
Secondary	Self-rating scales	Epworth Somnolence Scale(0-24);	Day -2 to Day 90