Sleep in Critically Ill Patients on Mechanical Ventilatio... | NCT02434341

Studies
Sleep in Critically Ill Patients on Mechanical Ventilation in ICU

NCT02434341

Sponsor

University of Southern Denmark

Status

Completed

Last Update Posted

Apr 28, 2016Estimated

Enrollment

33Actual

Phase

Not provided

Conditions

Polysomnographic Sleep Characteristics

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

Apr 30, 2015

First Posted Date

May 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2016

Last Update Posted Date

Apr 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuliya Boyko, Yuliya Boyko, ph.d. student, MD, University of Southern DenmarkPrincipal Investigator

Lead Sponsor

University of Southern DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
septic patients		wake septic patients on mechanical ventilation
COPD patients		wake COPD patients on mechanical ventilation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
polysomnographic sleep features		polysomnographic sleep assessment during up to 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

wake non-sedated patients
mechanical ventilation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

wake

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuliya Boyko, MD	University of Southern Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit, Odense University Hospital		Odense		5000	Denmark