Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment

March 24, 2015 updated by: Yuliya Boyko, Vejle Hospital

Sleep investigation in respirator treated ICU patients: the importance of intensive environment.

Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and increased mortality.

The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise, light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep quality in respirator treated ICU patients.

Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc. AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m. after randomization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, 7100
        • Department of Anaesthesia and Intensive Care, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • awake and relevant respirator treated patients with expected 2 or more respirator dags

Exclusion Criteria:

  • GCS < 11
  • cerebral hemorrhage or infarction during the current hospitalization
  • delirium
  • inotropes and/or vasopressors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 24 hour PSG under ordinary conditions
24 hour PSG in 46 patients under ordinary (routine) conditions
Active Comparator: 24 hours PSG under protocol 'Quiet in the room'
24 hour PSG in the same 46 patients with protocol 'Quiet in the room' from 10 p.m. til 6 a.m.
Behavioral: protocol 'Quiet in the room'

Protocol 'Quite in the room' between 10 p.m. and 6 a.m.

  • nurse nearby
  • no visits after 10 p.m.
  • decreased alarm sound in ventilator and monitor
  • decreased light intensity
  • no unnecessary conversations around the patient
  • medication should be limited to max 1-2 times in this time period
  • no unnecessary therapeutic or diagnostic procedures in this time period
  • earplugs and sleep masks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of arousals
Time Frame: per hour of sleep
arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted
per hour of sleep

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total sleep time
Time Frame: 24 hours
total sleep time during 24 hour period
24 hours
N1 sleep
Time Frame: 24 hours
N1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted
24 hours
N2 sleep
Time Frame: 24 hours
N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted
24 hours
N3 sleep
Time Frame: 24 hours
N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted
24 hours
REM sleep
Time Frame: 24 hours
REM sleep will be scored during sleep periods and the percent of REM sleep will be counted
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-20120001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

Clinical Trials on protocol 'Quiet in the room'

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe