NCT02801318

Brief 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. It is therefore essential to identify whether sleep deprivation and more specifically REM sleep alterations could facilitate occurence of delirium in ICU.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

First QC Date

July 16, 2015

Last Update Submit

October 10, 2016

Conditions

Keywords

Patient

Outcome Measures

Primary Outcomes (1)

  • significant difference of REM sleep quantity in polysomnography at day 3

    Day 3

Study Arms (1)

Polysomnography

OTHER
Procedure: Polysomnography

Interventions

Polysomnography

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Solène QUENTIN-PALOS, PH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

June 15, 2016

Primary Completion

March 1, 2018

Last Updated

October 12, 2016

Record last verified: 2016-10