Actively Recruiting
Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit
Led by Charite University, Berlin, Germany · Updated on 2024-06-26
50
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient capable of giving consent or has a legal guardian/authorized representative/spouse available for non-consenting patients in the intensive care unit
- Expected continuous lormetazepam therapy for 24 hours or longer
- Male and female patients aged 18 years or older
- Expected duration of intensive care treatment of 48 hours or longer
- Receiving mechanical ventilation (invasive, non-invasive, or nasal high-flow for more than 6 hours)
You will not qualify if you...
- Laboratory evidence of sedative or opiate intoxication
- Active alcohol abuse
- Brain surgery or cranial malformation
- History of sleep-related movement disorder such as symptomatic restless legs syndrome
- Allergy to electrode contact material
- History of severe cognitive impairment following a stroke
- Status after cardiopulmonary resuscitation requiring or undergoing therapeutic hypothermia
- Lack of consent for pseudonymized disease data storage and sharing in this study
- Patient housed in an institution by 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 excluding study participation
- Consent of patient or legal representative cannot be obtained in a timely manner
- Patients with survival probability less than 24 hours
- Narcolepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Charité - Universitätsmedizin Berlin
Mitte, State of Berlin, Germany, 10117
Actively Recruiting
Research Team
A
Alawi Luetz, Prof.Dr.med
CONTACT
L
Laura Hancke
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here