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Completed

NCT Number: NCT01681043

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

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.

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Key information

Conditions

Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesia and Intensive Care, Vejle Hospital

Vejle, 7100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

protocol 'Quiet in the room'

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 7, 2012
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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