Delirium SymptomsNCT02801318
Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery
A study testing Polysomnography in people with Delirium Symptoms, run by Poitiers University Hospital.
Trial summary
Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU), mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been described in ICU patients and is considered as a risk factor for delirium but its role is still unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium Symptoms
- What is being tested?
- Polysomnography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Mar 2018
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients who had a cardiac surgery with extracorporeal circulation.
- Patients who were extubated at Day 0.
- Patients without any operation or anesthetic complication.
- Patients who speak French.
- Patients without TNC at Day 1.
- Patients who had completed the questionnaires before operation.
Who cannot join
- Age < 18 years old.
- Delirium at Day 1.
- Central nervous system pathology or psychiatric pathology known and treated.
- Concomitant use of neuropsychiatric treatment before surgery that interferes with sleep.
- Clinical condition alteration before polysomnography exam.
- Continue sedation required before Day 3 polysomnography exam.
- Agitation or clinical alteration that did not allow Day 3 polysomnography exam.
Trial locations and contacts
No sites are listed yet.
Solène QUENTIN-PALOS, PH contact
About this study
Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU), mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been described in ICU patients and is considered as a risk factor for delirium but its role is still unknown. It is therefore essential to identify whether sleep deprivation and more specifically REM sleep alterations could facilitate occurence of delirium in ICU.
- Conditions
- Delirium Symptoms
- Being tested
- Polysomnography
- Keywords
- Patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Polysomnography | Other | Not described Receives: Procedure: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
significant difference of REM sleep quantity in polysomnography at day 3
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Primary completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium SymptomsStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801318
- Sponsor's protocol ID
- DELI-SLEEP
- Status last verified
- Oct 2016
- First submitted
- 16 Jul 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02801318
- Acronym / sponsor ID
- DELI-SLEEP
- Conditions
- Delirium Symptoms
- Keywords
- Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Primary completion
- Mar 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- 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.
Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU), mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been described in ICU patients and is considered as a risk factor for delirium but its role is still unknown. It is therefore essential to identify whether sleep deprivation and more specifically REM sleep alterations could facilitate occurence of delirium in ICU.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polysomnography | Other | Procedure: Polysomnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who had a cardiac surgery with extracorporeal circulation.
- Patients who were extubated at Day 0.
- Patients without any operation or anesthetic complication.
- Patients who speak French.
- Patients without TNC at Day 1.
Key exclusion criteria (7 listed)
- Age < 18 years old.
- Delirium at Day 1.
- Central nervous system pathology or psychiatric pathology known and treated.
- Concomitant use of neuropsychiatric treatment before surgery that interferes with sleep.
- Clinical condition alteration before polysomnography exam.
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 |
|---|---|---|
| Polysomnography | Procedure or surgery | Polysomnography |
Primary outcome
significant difference of REM sleep quantity in polysomnography at day 3
Time frame: Day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
Related trials for Delirium Symptoms
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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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.
Solène QUENTIN-PALOS, PH contact
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography in people with Delirium Symptoms, run by Poitiers University Hospital.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Solène QUENTIN-PALOS, PH (0549443159), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant difference of REM sleep quantity in polysomnography at day 3 (time frame: Day 3). 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 12 Oct 2016.