Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called lormetazepam, which helps with sleep and sedation, affects brain activity in critically ill patients in the intensive care unit (ICU). Researchers will look at special readings from the brain, known as EEGs, to see how lormetazepam impacts sleep quality and how deeply patients are sedated. Participants will receive lormetazepam continuously for at least 24 hours and will have their brain activity measured up to three times over a 24-hour period. This study aims to gather information that could help improve care for patients who have trouble sleeping while in the ICU.

To be eligible for this trial, participants must be at least 18 years old, able to give consent or have someone to assist them if they can't, and expected to receive lormetazepam therapy for at least a day. They should also be in the ICU for at least two days and may be on a ventilator. Participants can expect to receive the medication as prescribed by their doctor and will undergo brain activity tests after starting the medication. Importantly, this study will not involve a comparison group, but researchers will analyze data from the first 15 patients to refine the study as needed for better results.

Gender

ALL

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