ConsciousnessCONSCIOUS-ICUNCT07048951
Episodes of (Dis)Connected Consciousness in ICU Survivors
An observational study of Consciousness and Near Death Experience, run by University of Liege at 1 site in Belgium.
Trial summary
This single-center observational study aims to describe the incidence of episodes of connected consciousness and disconnected consciousness (including near-death experience (NDE) and out-of-body experiences) in patients who survived a prolonged stay of at least 7 days in the intensive care unit (ICU) and who had at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consciousness, Near Death Experience, ICU
- What is being tested?
- The Near-Death Experience Content (NDE-C) scale, Threat perception measure and Interview about the participant's memories of the ICU
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted in the ICU
Who may be able to join
- Adult patients who survived a ≥7 days stay in the intensive care unit
- Experienced a pharmacological or non-pharmacological episode of loss of consciousness
- French speaking
Who cannot join
- Refusal
- Chronic disorder of consciousness
- Confusion or delirium
- Deafness
- Blindness
- Aphasia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Episodes of (Dis)Connected Consciousness Among Patients Who Survived a Critical Illness
This single-center observational study aims to describe the incidence of episodes of connected consciousness and disconnected consciousness (including near-death experience (NDE) and out-of-body experiences) in patients who survived a prolonged stay of at least 7 days in the intensive care unit (ICU) and who had at least one episode of pharmacological or non-pharmacological coma. The investigators are also investigating the risk factors related to these episodes of consciousness. A follow-up at six months aims to explore the long-term psychological implications of these episodes.
- Conditions
- Consciousness, Near Death Experience, ICU, Critical Illness
- Being tested
- The Near-Death Experience Content (NDE-C) scale, Threat perception measure, Interview about the participant's memories of the ICU
- Keywords
- near-death experience, out-of-body experience
- Medical subject headings
- Death, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Near-Death Experience Content (NDE-C) scaleDiagnostic test
Questionnaire to detect occurence of NDE. A NDE is identified if score > or = 27/80
Threat perception measureOther
7 items scale investigating the participant's psychological vulnerability during their stay at the ICU
Interview about the participant's memories of the ICUOther
Participants will be asked to describe any dream, hallucination, or any other unusual experience they can recall from their stay at the ICU.
Additionally, the participants will be asked to describe any memory they have of the environment of the ICU, such as the appearance of the room, medical staff, family visiting, noises, etc.
| Study group | Role | What they receive |
|---|---|---|
| Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma | Not described Receives: Diagnostic Test: The Near-Death Experience Content (NDE-C) scale; Other: Threat perception measure; Other: Interview about the participant's memories of the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of potential episodes of disconnected consciousness
Near-death experience (using the Near-Death Experience Content scale, min-max: 0-80, with ≥27/80 indicating the presence of a NDE); dream
Measured: Within the week following discharge from the ICU (max 7 days after)
Detection of potential episodes of connected consciousness
Explicit recall of environmental/external stimuli in the ICU
Measured: Within the week following discharge from the ICU (max 7 days after)
Secondary outcomes (3)
Risk factors
(Neuro)physiological marker
Measured: Within the week following discharge from the ICU (max 7 days after)
Psychological vulnerability during the stay at the ICU
Using the Threat Perception Measure, a scale that contains 7 items related to feelings and anxieties perceived by the patient, each scored from 1 to 4, ranging from 1 "Not at all", 2 "A little", 3 "Moderately", and 4 "Extremely", as well as a "don 't remember" category. Min-max: 7-28, with higher scores indicating a higher level of perceived threat
Measured: Within the week following discharge from the ICU (max 7 days after)
Psychological impact of the stay at the ICU
Any patient who stayed at least 7 days at the ICU is invited to a 6 month follow-up during which they will be presented Hospital Anxiety and Depression Scale (HADS, min-max: 0-42, with higher scores indicating a worse outcome, i.e., more severe symptoms of anxiety or depression), to assess anxiety and depression as well as the Post-Traumatic Stress Assessment Questionnaire (IES-R, min-max: 0-88, with higher scores indicating a worse outcome, i.e., more severe post-traumatic stress symptoms).
The investigators will be asking two additional questions to investigate a possible impact on the patient's beliefs.
- Question 1: "Since your stay in intensive care, have your beliefs/opinions changed regarding death?".
- Question 2: "Has your stay in intensive care modified your fear of health care institutions?
Measured: At a 6 month follow-up after discharge from the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConsciousnessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048951
- Sponsor's protocol ID
- 2024-254
- Acronym
- CONSCIOUS-ICU
- Status last verified
- Dec 2024
- First submitted
- 7 Apr 2025
- Last updated
- 3 Jul 2025
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Episodes of (Dis)Connected Consciousness Among Patients Who Survived a Critical Illness
- ClinicalTrials.gov ID
- NCT07048951
- Acronym / sponsor ID
- CONSCIOUS-ICU / 2024-254
- Conditions
- Consciousness, Near Death Experience, ICU, Critical Illness
- Keywords
- near-death experience, out-of-body experience
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Jul 2025 (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.
This single-center observational study aims to describe the incidence of episodes of connected consciousness and disconnected consciousness (including near-death experience (NDE) and out-of-body experiences) in patients who survived a prolonged stay of at least 7 days in the intensive care unit (ICU) and who had at least one episode of pharmacological or non-pharmacological coma. The investigators are also investigating the risk factors related to these episodes of consciousness. A follow-up at six months aims to explore the long-term psychological implications of these episodes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma | – | Diagnostic Test: The Near-Death Experience Content (NDE-C) scale, Other: Threat perception measure, Other: Interview about the participant's memories of the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted in the ICU
Key inclusion criteria (3 listed)
- Adult patients who survived a ≥7 days stay in the intensive care unit
- Experienced a pharmacological or non-pharmacological episode of loss of consciousness
- French speaking
Key exclusion criteria (6 listed)
- Refusal
- Chronic disorder of consciousness
- Confusion or delirium
- Deafness
- Blindness
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 |
|---|---|---|
| The Near-Death Experience Content (NDE-C) scaleQuestionnaire to detect occurence of NDE. A NDE is identified if score > or = 27/80 | Diagnostic test | Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma |
| Threat perception measure7 items scale investigating the participant's psychological vulnerability during their stay at the ICU | Other | Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma |
| Interview about the participant's memories of the ICUParticipants will be asked to describe any dream, hallucination, or any other unusual experience they can recall from their stay at the ICU. Additionally, the participants will be asked to describe any memory they have of the environment of the ICU, such as the appearance of the room, medical staff, family visiting, noises, etc. | Other | Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma |
Primary outcome
Detection of potential episodes of disconnected consciousness
Time frame: Within the week following discharge from the ICU (max 7 days after)
Near-death experience (using the Near-Death Experience Content scale, min-max: 0-80, with ≥27/80 indicating the presence of a NDE); dream
Detection of potential episodes of connected consciousness
Time frame: Within the week following discharge from the ICU (max 7 days after)
Explicit recall of environmental/external stimuli in the ICU
3 secondary outcomes
Risk factors
Time frame: Within the week following discharge from the ICU (max 7 days after)
Psychological vulnerability during the stay at the ICU
Time frame: Within the week following discharge from the ICU (max 7 days after)
Psychological impact of the stay at the ICU
Time frame: At a 6 month follow-up after discharge from the ICU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consciousness and Near Death Experience, run by University of Liege at 1 site in Belgium.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Martial, PhD (+3243233612, cmartial@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of potential episodes of disconnected consciousness (time frame: Within the week following discharge from the ICU (max 7 days after)). The study lists 2 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 3 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.