Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction

NCT04481347 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-10-25

No results posted yet for this study

Summary

The challenge of new recommendations and better adapted practices is pushing to operate patients who are getting older and more fragile. In this context, there is an inevitable increase in the risks associated with care and in particular perioperative neurological complications, of which postoperative cognitive dysfunction (POCD) is the most common.

The interest of perioperative cerebral monitoring and in particular electroencephalography (EEG) to reduce neurological and cognitive damage in surgery has been the subject of abundant research and corresponds to a crucial issue.

From the literature and preliminary results obtained in our clinical research unit, it appears that there is also a relationship between certain characteristics of the peroperative EEG (signal strength and burst suppression) and the occurrence of postoperative cognitive dysfunction (PCOD).

In this context, quantitative analysis of the preoperative sleep EEG and the EEG obtained during general anesthesia could allow the identification of a simple to use biomarker of susceptibility or fragility. To our knowledge, there is no preoperative evaluation strategy using EEG analysis to detect a predisposition to POCD.

The main goal of this observational clinical study is to extend the traditional use of per-operative EEG with pre-operative and post-operative sleep EEG for the detection and prediction of early post-operative cognitive dysfunction.

Conditions

  • Postoperative Cognitive Dysfunction

Interventions

DEVICE

Sleep EEG recording using a DREEM® headband

Sleep EEG recording using a Dreem® headband (Rythm, Paris, France), an EEG recording device adapted to sleep conditions and completely non-invasive

OTHER

Montreal Cognitive Assessment (MoCA)

Neuropsychological assessment using the The Montreal Cognitive Assessment (MoCA) questionnaire to detect postoperative cognitive dysfunction

DEVICE

Intraoperative EEG recording using a Sedline® monitoring

Intraoperative brain function monitoring using a Sedline® module (Masimo corporation) to evaluate the state of the brain under anesthesia

Sponsors & Collaborators

  • INSERM UMR-942, Paris, France

    collaborator OTHER
  • LMS Ecole polytechnique and M3DISIM, Inria

    collaborator UNKNOWN
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Joaquim MATEO, MD · Assistance Publique - Hôpitaux de Paris

  • Fabrice VALLEE, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

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 NCT04481347 on ClinicalTrials.gov