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Trial record 4 of 12434 for:    sleep

Sleep Bundle for Improving Sleep in ICU Patients

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: NCT03247062
Recruitment Status : Unknown
Verified May 2017 by Pr. Bara RICOU, University Hospital, Geneva.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):
Pr. Bara RICOU, University Hospital, Geneva

Brief Summary:

Summary of the project :

Lack or disturbances of sleep are major problems in patients staying in intensive care unit (ICU) due to the particular environment. The noises, lack of circadian rhythm of light lead to progressive deafferentation. The patients are then at risk of immune deficiencies, agitation and confusion states, cognitive troubles that may be associated to increased morbidity and mortality in the short and long term. Thus, improvement of the sleep of the ICU patients may impact non only during the ICU stay but also on their future quality of life.

The sleep bundle project is a quality improvement project with a before-after design, consisting in the evaluation of a bundle of measures that may increase the quality and duration of sleep in ICU patients.

The bundle consists in the proposition of eye-mask, ear-plugs, music and/or massage to the patients in parallele to structural and organizational modifications of the service such as the decrease of the alarms sounds, changing the luminosity between day and night, etc.

The principal indicators followed will be:

  • The sleep quality of the patients
  • The continuous noise intensity in the rooms
  • The continuous light intensity in the rooms Baseline - before period: 8 weeks Implementation of the bundle with training of the team: 4 weeks After period: 8 weeks.

Condition or disease Intervention/treatment Phase
Sleep Intensive Care Unit Syndrome Other: Quality improvement - sleep bundle Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Quality improvement project - before after design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving the Quality of Sleep in ICU Patients With a "Sleep Bundle"
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : August 31, 2018

Arm Intervention/treatment
Cohort study (Before-after desgin)

Quality improvement - sleep bundle Intervention consists in a sleep bundle, an aggregate of several propositions to improve the sleep of patients.: implementation of a sleep bundle.

The entire ICU population will be observed before and after intervention.

Other: Quality improvement - sleep bundle
implementation of a sleep bundle
Other Name: A sleep bundle to improve the sleep of patients.

Primary Outcome Measures :
  1. Improvement of the quality of sleep in ICU patients measured by the Richards Campbell Sleep Questionnaire (RCSQ) [ Time Frame: 6 months ]
    Before-after design aiming at increasing the Richards Campbell Sleep Questionnaire (RCSQ) of ICU patients.

Secondary Outcome Measures :
  1. agitation episodes [ Time Frame: 6 months ]
    SAS > 6

  2. delirium [ Time Frame: 6 months ]
    CAM ICU +

  3. patient related incident [ Time Frame: 6 months ]
    unvoluntary extubation, cathéters or tube retrieval

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients (≥ 18 yo),
  • Hospitalised for ≥ 24h in ICU
  • Planned stay of more than 1 day
  • After termination of sedation
  • Glasgow ≥ 12, SAS ≥ 3-4, CAM-ICU negative

Exclusion Criteria:

  • patients with neueological disease or neurosurgery requiring neurological assessment every 4hours or more

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Responsible Party: Pr. Bara RICOU, Professor, University Hospital, Geneva Identifier: NCT03247062     History of Changes
Other Study ID Numbers: ICU Sleep - 01
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pr. Bara RICOU, University Hospital, Geneva:
agitation, sleep deprivation, bundle