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

This study is currently recruiting participants.
Verified March 2013 by Vejle Hospital
Sponsor:
Information provided by (Responsible Party):
Yuliya Boyko, Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01681043
First received: August 23, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Sleep
 Behavioral: protocol 'Quiet in the room'

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • the number of arousals [ Time Frame: per hour of sleep ] [ Designated as safety issue: No ]
    arousals will be scored during the sleep periods and the index - arousals per hour of sleep - will be counted


Secondary Outcome Measures:
  • total sleep time [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    total sleep time during 24 hour period

  • N1 sleep [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    N1 sleep stage will be scored during sleep periods (dag sleep/night sleep)and the percent of N1 sleep will be counted

  • N2 sleep [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted

  • N3 sleep [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted

  • REM sleep [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    REM sleep will be scored during sleep periods and the percent of REM sleep will be counted


Estimated Enrollment: 46
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681043

Locations
Denmark
Department of Anaesthesia and Intensive Care, Vejle Hospital Recruiting
Vejle, Denmark, 7100
Contact: Yuliya Boyko, MD     +45 41128794     yuliya.boyko@slb.regionsyddanmark.dk    
Principal Investigator: Yuliya Boyko, MD            
Sponsors and Collaborators
Vejle Hospital
  More Information

No publications provided

Responsible Party: Yuliya Boyko, MD, Vejle Hospital
ClinicalTrials.gov Identifier: NCT01681043     History of Changes
Other Study ID Numbers: S-20120001
Study First Received: August 23, 2012
Last Updated: March 20, 2013
Health Authority: The Regional Scientific Ethical Committee for Southern Denmark: Denmark

Keywords provided by Vejle Hospital:
Sleep

ClinicalTrials.gov processed this record on May 21, 2013