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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how continuous infusion of lormetazepam affects brain activity, sleep quality, and sedation depth in critically ill patients in an intensive care unit (ICU). The study focuses on patients who require sedation and are expected to receive lormetazepam continuously for at least 24 hours. It explores specific EEG patterns related to sleep stages and sedation effects to improve sedation monitoring and potentially reduce complications like delirium and cognitive damage. Participants will receive lormetazepam infusion as determined by their ICU physician. Brain activity will be monitored using up to three 24-hour EEG recordings with the X8 Sleep Profiler RTA device, starting at least two hours after beginning lormetazepam infusion. This observational pilot study does not have a comparison group but includes an interim analysis after 15 patients to assess the measurement approach and possibly adjust study procedures. During the study, patients will undergo EEG monitoring to record various sleep and brain activity parameters including REM sleep, slow wave sleep, gamma oscillations, and sedation depth. Additional clinical data such as delirium incidence, sedation scales, ventilation duration, and organ function scores will also be collected. The study aims to enroll 50 ICU patients expected to require intensive care for at least 48 hours and continuous lormetazepam infusion for 24 hours or more. The total participation spans several days with repeated EEG and clinical assessments to evaluate sedation and sleep quality in this critical setting.
CONDITIONS
Brief 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 having a legal guardian/authorized representative/spouse available
- Expected continuous lormetazepam therapy of at least 24 hours
- Male and female patients aged 18 years or older
- Expected intensive care treatment duration 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
- Undergoing therapeutic hypothermia after cardiopulmonary resuscitation
- Lack of consent for pseudonymized data storage and sharing
- 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 will excluding study participation
- Consent cannot be obtained in a timely manner
- Survival probability less than 24 hours
- Diagnosis of narcolepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Immediately after ICU admission and reevaluated daily
Participants are screened for eligibility to participate in the trial.
Daily screening during ICU stay
Duration - Approximately 3 days during ICU stay
Participants receiving continuous lormetazepam infusion undergo episodic EEG recordings to assess sleep quality and brain activity patterns.
Up to 3 EEG measurement sessions over 24 hours each
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
L
Laura Hancke
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
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