WithdrawnNot Applicable

Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients

Stopped: material issue

0Started 2025-10-09

Plain-language 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 and lexical processing, self-processing), and to develop a prognostic evaluation of neurocognitive and psychological disorders using an innovative non-behavioral approach.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional connectivity: weighted Symbolic Mutual Information (wSMI) measured at rest by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Trial details

NCT IDNCT06206473

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-09

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Functional connectivity: weighted Symbolic Mutual Information (wSMI) measured at rest by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

Timeframe: Baseline