Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit

NCT06473415 | Recruiting

• 1 other identifier: 20019702
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  through study completion per patient, an average of 3 days

Secondary Outcomes (50)

• 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

  through study completion per patient, an average of 3 days

• 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.

  through study completion per patient, an average of 3 days

• Total and % time atypical N3 sleep (AN3) i.e. polymorphic delta or or sepsis associated encephalopathy

  through study completion per patient, an average of 3 days

• Gamma oscillations

  through study completion per patient, an average of 3 days

• Theta-Gamma Coupling

  through study completion per patient, an average of 3 days

Interventions

Electroencephalography DIAGNOSTIC_TEST

Electroencephalography using the Sleep-Profiler device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 male and female critically ill patients aged 18 years or older

You may qualify if:

• 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
• Mechanical ventilation (invasive, NIV and/or nasal high-flow \> 6h)

You may not qualify if:

• Laboratory evidence of sedative/opiate intoxication
• Active alcohol abuse
• Brain surgery, cranial malformation
• History of sleep-related movement disorder (symptomatic restless legs syndrome)
• Allergy to electrode contact material
• History of severe cognitive impairment following a stroke
• Status post cardiopulmonary resuscitation requiring/undergoing therapeutic hypothermia
• Lack of consent for the pseudonymized disease data to be stored and passed on in the context of this clinical study
• Patient is housed in an institution on 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, in which the patient fundamentally excludes participation in studies
• The patient's consent or that of the legal representative cannot be obtained in a timely manner
• Patients with a survival probability \< 24h

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Mitte, State of Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Critical Illness; Delirium; Sleep Disorders, Circadian Rhythm

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Chronobiology Disorders; Dyssomnias; Sleep Wake Disorders; Occupational Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Alawi Luetz, Prof.Dr.med

CONTACT

+4930450631208; alawi.luetz@charite.de

Laura Hancke

CONTACT

+4930450651309; laura.hancke@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 25, 2024
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)