Chronic InsomniaNCT04958382
Study for Evaluating the Efficacy of Ciprofol in Patients Under Narcotic Sleep With Chronic Insomnia
A study testing ciprofol and medium/long chain fat emulsion injection (C8-24Ve) in people with Chronic Insomnia, run by Sichuan Provincial People's Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- ciprofol and medium/long chain fat emulsion injection (C8-24Ve)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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:
- Any clinical study within 1 month before screening;
- Sedatives/anesthetics, and/or sedative-hypnotics within 72 h before baseline;
- Antidepressants and anxiolytics within 14 days before baseline;
- Laboratory test abnormalities at screening:
- Total bilirubin > 2 × ULN (upper limit of normal);
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) > 2 × ULN;
- Blood creatinine > 1.5 × ULN;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Insomnia
- Being tested
- ciprofol, medium/long chain fat emulsion injection (C8-24Ve)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofolDrug
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)Drug
at the infusion rate of 25-30 mL/h
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol | Experimental | Not described Receives: Drug: ciprofol |
| placebo | Placebo comparator | Not described Receives: Drug: medium/long chain fat emulsion injection (C8-24Ve) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography (PSG)
total sleep time (TST)
Measured: Day -2 to Day 90
Polysomnography (PSG)
sleep latency (SL)
Measured: Day -2 to Day 90
Polysomnography (PSG)
wake after sleep onset (WASO)
Measured: Day -2 to Day 90
Sleep log
subjective total sleep time (sTST)
Measured: Day -2 to Day 90
Sleep log
subjective sleep-onset latency (sSOL)
Measured: Day -2 to Day 90
Sleep log
subjective wake after sleep onset (sWASO)
Measured: Day -2 to Day 90
Secondary outcomes (5)
Self-rating scales
Pittsburgh Sleep Quality Index (PSQI)（0-21）
Measured: Day -2 to Day 90
Self-rating scales
Insomnia Severity Index (ISI)（0-28）
Measured: Day -2 to Day 90
Self-rating scales
PHQ-9 Depression Test Questionnaire（0-27）
Measured: Day -2 to Day 90
Self-rating scales
GAD-7 Anxiety Test Questionnaire（0-21）
Measured: Day -2 to Day 90
Self-rating scales
Epworth Somnolence Scale（0-24）;
Measured: Day -2 to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengchang Yang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958382
- Sponsor's protocol ID
- HSK3486-IIT-01
- Status last verified
- Nov 2023
- First submitted
- 24 Jun 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Single Blind, Exploratory Study for Evaluating the Efficacy of Ciprofol in Patients Under Narcotic Sleep With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT04958382
- Acronym / sponsor ID
- HSK3486-IIT-01
- Conditions
- Chronic Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol | Experimental | Drug: ciprofol |
| placebo | Placebo comparator | Drug: medium/long chain fat emulsion injection (C8-24Ve) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (27 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciprofolintravenous infusion of ciprofol at 0.12 mg/kg, followed by 0.4-1.6 mg/kg/h for maintenance | Drug | Ciprofol |
| medium/long chain fat emulsion injection (C8-24Ve)at the infusion rate of 25-30 mL/h | Drug | placebo |
Primary outcome
Polysomnography (PSG)
Time frame: Day -2 to Day 90
total sleep time (TST)
Polysomnography (PSG)
Time frame: Day -2 to Day 90
sleep latency (SL)
Polysomnography (PSG)
Time frame: Day -2 to Day 90
wake after sleep onset (WASO)
Sleep log
Time frame: Day -2 to Day 90
subjective total sleep time (sTST)
Sleep log
Time frame: Day -2 to Day 90
subjective sleep-onset latency (sSOL)
Sleep log
Time frame: Day -2 to Day 90
subjective wake after sleep onset (sWASO)
5 secondary outcomes
Self-rating scales
Time frame: Day -2 to Day 90
Self-rating scales
Time frame: Day -2 to Day 90
Self-rating scales
Time frame: Day -2 to Day 90
Self-rating scales
Time frame: Day -2 to Day 90
Self-rating scales
Time frame: Day -2 to Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ciprofol and medium/long chain fat emulsion injection (C8-24Ve) in people with Chronic Insomnia, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography (PSG) (time frame: Day -2 to Day 90). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.