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Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit

NCT06473415 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-06-26

No results posted yet for this study

Summary

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

  • Critical Illness
  • Delirium
  • Sleep Disorders, Circadian Rhythm

Interventions

DIAGNOSTIC_TEST

Electroencephalography

Electroencephalography using the Sleep-Profiler device

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-12-01
Completion
2024-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06473415 on ClinicalTrials.gov