Acute Respiratory Distress SyndromeDeSignNCT06206473
Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients
A study testing mEEG assessment in people with Acute Respiratory Distress Syndrome and Delirium, run by University Hospital, Toulouse.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Delirium
- What is being tested?
- mEEG assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2025to 9 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome, Delirium
- Being tested
- mEEG assessment
- Keywords
- P300, N400, self-processing, semantic priming, functional connectivity
- Medical subject headings
- Respiratory Distress Syndrome, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mEEG assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients with ARDS and delirium | Experimental | 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. Receives: Other: mEEG assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity: weighted Symbolic Mutual Information (wSMI) measured at rest by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
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)
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
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
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
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
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
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
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
- 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
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
- 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)
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
- 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)
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
- 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)
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
- 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)
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
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)
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
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)
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
- 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)
Measured: Baseline
Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium
- 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start9 Oct 2025
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Why it stopped: material issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center cohort (Intensive Care Unit of the Toulouse University Hospital), prospective, longitudinal, interventional, proof of concept study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice FERRE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206473
- Sponsor's protocol ID
- RC31/22/0487
- Other IDs
- 2023-A00279-36
- Acronym
- DeSign
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients: Diagnostic and Prognostic Electrophysiological Signatures
- ClinicalTrials.gov ID
- NCT06206473
- Acronym / sponsor ID
- DeSign / RC31/22/0487
- Conditions
- Acute Respiratory Distress Syndrome, Delirium
- Keywords
- P300, N400, self-processing, semantic priming, functional connectivity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: material issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center cohort (Intensive Care Unit of the Toulouse University Hospital), prospective, longitudinal, interventional, proof of concept study
| Arm | Type | Receives |
|---|---|---|
| ICU patients with ARDS and delirium | Experimental | Other: mEEG assessmentICU 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mEEG assessmentmEEG 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. | Other | ICU patients with ARDS and delirium |
Primary outcome
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)
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice FERRE, MD principal investigator
University Hospital, Toulouse
Questions about this trial
What is this clinical trial studying?
A study testing mEEG assessment in people with Acute Respiratory Distress Syndrome and Delirium, run by University Hospital, Toulouse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity: weighted Symbolic Mutual Information (wSMI) measured at rest by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.