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

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: NCT01681043
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : March 25, 2015
Information provided by (Responsible Party):
Yuliya Boyko, Vejle Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Sleep Behavioral: protocol 'Quiet in the room' Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Study Start Date : September 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. total sleep time [ Time Frame: 24 hours ]
    total sleep time during 24 hour period

  2. 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

  3. N2 sleep [ Time Frame: 24 hours ]
    N2 sleep stage will be scored during sleep periods and the percent of N2 sleep will be counted

  4. N3 sleep [ Time Frame: 24 hours ]
    N3 sleep stage will be scored during sleep periods and the percent of N3 sleep will be counted

  5. REM sleep [ Time Frame: 24 hours ]
    REM sleep will be scored during sleep periods and the percent of REM sleep will be counted

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

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

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): NCT01681043

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Department of Anaesthesia and Intensive Care, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
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Responsible Party: Yuliya Boyko, MD, Vejle Hospital Identifier: NCT01681043    
Other Study ID Numbers: S-20120001
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Yuliya Boyko, Vejle Hospital: