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

Qualifiers

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 design

Treatments tested in this trial

  • Electroencephalography

Treatment groups

No treatment groups listed