NCT06473415 Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit
| NCT ID | NCT06473415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-12-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test the effect of continuous lormetazepam infusion on EEG patterns in critically ill patients who are given continuous infusion of lormetazepam in an intensive care unit setting. The main questions it aims to answer are: • How does the continuous infusion of lormetazepam affect EEG readings in terms of specific patterns related to sleep quality and sedation depth? Participants will be asked to: * Receive continuous infusion of lormetazepam, administered as per the guidelines and judgment of the on-duty ward physician. * Undergo up to three EEG measurements over a period of 24 hours each using the X8 Sleep Profiler RTA device. These measurements will monitor brain activity and other related signals in order to assess the sedation depth and sleep quality. * These EEG readings will be performed after at least two hours of initiation of continuous lormetazepam infusion, potentially at different stages of their ICU stay. There is no direct comparison group in this study. However, after initial data from the first 15 patients is collected, an interim analysis will be performed. This will help researchers understand the ability to measure sleep quality and defined EEG parameters in this setup, and if necessary, adapt the study design or measurement procedures for better outcomes.
Eligibility Criteria
Inclusion Criteria: * Patient capable of giving consent or additional legal guardian/authorized representative/spouse available for non-consenting patient in the intensive care unit * An expected continuous lormetazepam therapy ≥ 24 hours * Male and female patients aged ≥18 years * Expected duration of intensive care treatment ≥ 48 hours * Mechanical ventilation (invasive, NIV and/or nasal high-flow \> 6h) Exclusion Criteria: * Laboratory evidence of sedative/opiate intoxication * Active alcohol abuse * Brain surgery, cranial malformation * History of sleep-related movement disorder (symptomatic restless legs syndrome) * Allergy to electrode contact material * History of severe cognitive impairment following a stroke * Status post cardiopulmonary resuscitation requiring/undergoing therapeutic hypothermia * Lack of consent for the pseudonymized disease data to be stored and passed on in the context of this clinical study * Patient is housed in an institution on court or official order * History of sleep-related breathing disorder * Suspicion of hypoxic brain damage (including intracranial hemorrhages) * Suspicion of increased intracranial pressure * Existing power of attorney or patient's will, in which the patient fundamentally excludes participation in studies * The patient's consent or that of the legal representative cannot be obtained in a timely manner * Patients with a survival probability \< 24h * Narcolepsy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06473415 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06473415 currently recruiting?
Yes, NCT06473415 is actively recruiting participants. Contact the research team at alawi.luetz@charite.de for enrollment information.
Where is the NCT06473415 trial being conducted?
This trial is being conducted at Mitte, Germany.
Who is sponsoring the NCT06473415 clinical trial?
NCT06473415 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 50 participants.