Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients (DeSign)

June 24, 2026 updated by: University Hospital, Toulouse

Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients: Diagnostic and Prognostic Electrophysiological Signatures

Early cognitive assessment of critically-ill acute respiratory distress syndrome (ARDS) patients with delirium using a multidimensional electrophysiological evaluation battery (mEEG) to identify and characterize the neural correlates of cognitive dysfunctions associated with delirium (vigilance, attention, semantic and lexical processing, self-processing), and to develop a prognostic evaluation of neurocognitive and psychological disorders using an innovative non-behavioral approach.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Delirium is an altered mental status associated with specific manifestations such as reduced ability to direct, focus, maintain and shift attention (DSM V criteria). The vulnerability of critically-ill ARDS patients explains the high incidence of delirium (up to 80%) in this setting. Delirium is an independent predictor of post-traumatic stress disorder, long term cognitive decline and mortality. To reduce this medical and social burden, a more complete description of delirium is needed both in terms of cognitive impairments and long term neurological and neuropsychological impact. Actually, it could be argued that the current exclusive behavioral assessment of these patients is insufficient in terms of diagnosis and prognostic assessment. In recent years, the study of consciousness has made major progress thanks to the use of innovative electrophysiological exploration methods. This work has notably allowed the development of new non-behavioral tools for the exploration of brain function in brain damaged patients in response to complex auditory stimulations (multidimensional electrophysiological battery, mEEG). In this context, the investigator team has recently demonstrated alterations in cognitive functions related to language- and self-processing in ARDS patients with severe acute respiratory syndrome (SARS)-CoV2 infection. These electrophysiological cognitive alterations were particularly marked in COVID-19 patients with delirium. Further studies are needed to disentangle the cognitive impact specifically related to delirium from that related to a severe form of COVID-19. The primary objective of this study is to identify diagnostic electrophysiological signatures of cognitive dysfunctions associated with the acute phase of delirium in critically-ill ARDS patients using a multidimensional electrophysiological assessment (mEEG) recording at rest and during auditory stimulation (first visit, V1). Secondary objectives are to characterize the impact of intensive care unit (ICU)-related delirium on neurocognitive and psychological dysfunctions observed at 6 months (second visit, V2), in order to explore the prognostic predictive value of electrophysiological data acquired during the acute phase of delirium.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients admitted to the intensive care unit with ARDS (according to Berlin criteria)
  • Delirium (according to Confusion Assessment Method (CAM)-ICU criteria)
  • Membership of a social security scheme
  • Signed consent of the referring person
  • Discontinuation of any sedative agent for ≥ 72 hours

Exclusion Criteria:

  • Pre-existing psychotic disorders
  • Pre-existing cognitive deficits (short Informant Questionnaire on Cognitive Decline in the Elderly (short IQCODE) ≥ 3,4)
  • Recent ICU admission (> 5 days of ICU hospitalization within 6 months prior to current ICU admission)
  • Patients whose delirium cannot be reliably assessed due to blindness, deafness or inability to speak French
  • Patients whose life expectancy is unlikely to exceed 24 hours
  • Pregnant ans breastfeeding women
  • Patients under court protection
  • Patients who have already participated in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICU patients with ARDS and delirium
ICU patients with ARDS and delirium will be assessed twice: in the acute phase of ICU-related delirium (V1) using an mEEG battery (electrophysiological acquisition at rest and during complex cognitive stimulation), and 6 months ± 2 weeks later (V2) using a multi-domain clinical neurocognitive and psychological assessment battery.
Other: mEEG assessment
mEEG assessment (V1) will be performed at the patient's bed within 72 hours of the diagnosis of delirium. The mEEG recording, which lasts approximately 2 hours, will be performed by one of the investigators with expertise in electrophysiological acquisition. This non-invasive assessment consists of placing an EEG net on the scalp of the participants and earphones through which the auditory stimuli will be delivered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional connectivity: weighted Symbolic Mutual Information (wSMI) measured at rest by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
Analysis of data from the multidimensional electrophysiological battery (mEEG) at rest during the acute phase of delirium: continuous value (between 0 and 1) of weighted Symbolic Mutual Information (wSMI)
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
Analysis of data from the multidimensional electrophysiological battery (mEEG) during auditory stimulation at the acute phase of delirium: subject's own name effect (subject's own name vs other first name) measured by spatio-temporal
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
Analysis of data from the multidimensional electrophysiological battery (mEEG) during auditory stimulation at the acute phase of delirium: local effect (local deviant tone vs local standard tone) measured by spatio-temporal clustering by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
Analysis of data from the multidimensional electrophysiological battery (mEEG) during auditory stimulation at the acute phase of delirium: global effect (global deviant tone vs global standard tone) measured by spatio-temporal clustering by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
• Analysis of data from the multidimensional electrophysiological battery (mEEG) during auditory stimulation at the acute phase of delirium: semantic effect (semantic unrelated words vs semantic related words) measured by spatio-temporal clustering by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
• Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 amplitude to subject's own name stimuli (microvolts)
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
• Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 amplitude to local deviant tones (microvolts)
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
• Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 amplitude to global deviant tones (microvolts)
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
• Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : N400 amplitude to semantic unrelated words (microvolts)
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 latency to subject's own name stimuli (milliseconds)
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 latency to local deviant tones (milliseconds)
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
• Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 latency to global deviant tones (milliseconds)
Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
Time Frame: Baseline
• Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : N400 latency to semantic unrelated words (milliseconds)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fabrice FERRE, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/22/0487
  • 2023-A00279-36 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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