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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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 30, 2014
Last verified: March 2014
  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: March 2015
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 30, 2014
Health Authority: The Regional Scientific Ethical Committee for Southern Denmark: Denmark

Keywords provided by Vejle Hospital:
Sleep

ClinicalTrials.gov processed this record on September 15, 2014