Effects of Lormetazepam on Sleep Quality in ICU Patients
Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit
This study tests if giving a medication called lormetazepam can improve sleep quality for patients in the ICU by looking at their brain activity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Mitte, State of Berlin) |
| Trial ID | NCT06473415 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how continuous infusion of lormetazepam affects EEG patterns related to sleep quality and sedation depth in critically ill patients. Participants will receive lormetazepam and undergo EEG measurements over a 24-hour period to monitor brain activity and assess the impact on their sleep and sedation. The study aims to provide insights into the sedative's effectiveness in improving sleep quality and managing delirium in an intensive care setting.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients aged 18 and older who are expected to receive continuous lormetazepam therapy for at least 24 hours.
Not a fit: Patients with a history of severe cognitive impairment, active alcohol abuse, or those undergoing therapeutic hypothermia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation practices and better sleep quality for critically ill patients in the ICU.
How similar studies have performed: While the use of lormetazepam in this context is relatively novel, previous studies have indicated potential benefits of benzodiazepines in managing sedation and sleep in ICU patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mitte, State of Berlin
- Charité - Universitätsmedizin Berlin — Mitte, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Alawi Luetz, Prof.Dr.med
- Email: alawi.luetz@charite.de
- Phone: +4930450631208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.