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Sleep in Critically Ill Patients on Mechanical Ventilation in ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02434341
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : April 28, 2016
Information provided by (Responsible Party):
Yuliya Boyko, University of Southern Denmark

Brief Summary:
15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo polysomnographic sleep monitoring up to 24 hours in order to define if there are common sleep features within the groups

Condition or disease
Polysomnographic Sleep Characteristics

Detailed Description:

It is an observational study in order to define if there are common polysomnographic sleep features within the following three groups of wake critically ill patients on mechanical ventilation in ICU: the group of septical patients, the group of patients with chronic obstructive pulmonary disease in exacerbation and the group of surgical patients without sepsis.

15 patients will be included in each group. They will undergo polysomnographic sleep monitoring during up to 24 hours.

Polysomnograms will be studies then in order to find out if there are common sleep characteristics within the homogeneous patient groups of critically ill.

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Investigation in 3 Homogeneous Groups of Wake Mechanically Ventilated Patients in ICU: 1st Group - Septical Patients; 2nd Group - COPD Patients; 3rd Group - Surgical Patients, in Order to Define Common Sleep Features Within the Groups
Study Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

septic patients
wake septic patients on mechanical ventilation
COPD patients
wake COPD patients on mechanical ventilation

Primary Outcome Measures :
  1. polysomnographic sleep features [ Time Frame: polysomnographic sleep assessment during up to 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • wake non-sedated patients
  • mechanical ventilation

Exclusion Criteria:

  • age < 18 years
  • pregnant
  • Glasgow Coma Scale < 11
  • sedated patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02434341

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Intensive Care Unit, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
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Principal Investigator: Yuliya Boyko, MD University of Southern Denmark
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Responsible Party: Yuliya Boyko, Yuliya Boyko, ph.d. student, MD, University of Southern Denmark Identifier: NCT02434341    
Other Study ID Numbers: s-20140207G
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016