Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorCharite University, Berlin, Germany
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Laboratory evidence of sedative/opiate intoxication
Active alcohol abuse
Brain surgery, cranial malformation
History of sleep-related movement disorder (symptomatic restless legs syndrome)
Trial population
50 male and female critically ill patients aged 18 years or older
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electroencephalography
Diagnostic testElectroencephalography using the Sleep-Profiler device
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
REM portion (%) during nocturnal sleep
Main Hypothesis: Intensive care patients who receive a continuous Lormetazepam infusion exhibit an electroencephalographically detectable REM portion of at least 20% during the nocturnal sleeping period bewetween 22:00 to 06:00.
Time frame
through study completion per patient, an average of 3 daysSecondary outcomes
1
Total sleep time attributed to stages N2, N3 or rapid eye movement (REM) sleep during the noctural period i.e., between the hours of 22:00 and 06:00
Total high qualitiy sleep time during nocturnal period, (sum REM,N2,N3; minutes)
Time frame
through study completion per patient, an average of 3 days2
Total minutes of all stages of sleep (including N1, AN3, NREM hypertonia) during the awake period i.e., between the hours of 06:00 and 22:00.
Total sleep time during awake period, (minutes)
Time frame
through study completion per patient, an average of 3 days3
Total and % time atypical N3 sleep (AN3) i.e. polymorphic delta or or sepsis associated encephalopathy
Total sleep time in atypical N3 (minutes; %)
Time frame
through study completion per patient, an average of 3 days4
Gamma oscillations
Hz)
Time frame
through study completion per patient, an average of 3 daysSponsors and contacts
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Source ClinicalTrials.gov