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

NCT04958382 | Unknown

• 1 other identifier: HSK3486-IIT-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Insomnia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Self-rating scales

  Day -2 to Day 90

• Self-rating scales

  Day -2 to Day 90

• Self-rating scales

  Day -2 to Day 90

• Self-rating scales

  Day -2 to Day 90

• Self-rating scales

  Day -2 to Day 90

Study Arms (2)

Ciprofol

EXPERIMENTAL

Drug: ciprofol

placebo

PLACEBO COMPARATOR

Drug: medium/long chain fat emulsion injection (C8-24Ve)

Interventions

ciprofol DRUG

intravenous infusion of ciprofol at 0.12 mg/kg, followed by 0.4-1.6 mg/kg/h for maintenance

Ciprofol

medium/long chain fat emulsion injection (C8-24Ve) DRUG

at the infusion rate of 25-30 mL/h

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• At least one of the following daytime symptoms: tiredness, short tempered, work/study/social skills decreased;
• Occurrence of the above symptoms at least 3 times per week and lasting for more than 3 months;
• Voluntarily adopt narcotic sleep and obtain the written informed consent form.

You may not qualify if:

• 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:
• 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);
• 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;
• 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);
• History of gastrointestinal disorders: gastrointestinal retention, active hemorrhage, or conditions that may lead to reflux and aspiration;
• History of blood donation or blood loss of ≥ 400 mL within 3 months before screening;
• With the following airway management risks at screening:
• History of asthma or stridor;
• Sleep apnea syndrome;
• History or family history of malignant hyperthermia;
• History of tracheal intubation failure;
• Judged by investigators to have difficult airway or judged as difficult tracheal intubation (modified Mallampati class IV) at screening;
• Receipt of any of the following medications/therapies at screening/baseline:

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Sichuan, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 12, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

CN (1)