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Improving Sleep Quality in ICU Patients (EARS)

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ClinicalTrials.gov Identifier: NCT02292134
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable consequence of cares.

The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep architecture and quality in ICU patients.


Condition or disease Intervention/treatment Phase
Intensive Care Unit Patients Device: earplug and sleep mask Phase 3

Detailed Description:

It is well demonstrated that sleep architecture is deeply altered in intensive care unit (ICU patients). The consequences of this alteration are multiple: neuropsychological complication such as delirium, long-term sequels such as post-traumatic stress disorders, alteration of the circadian fluctuation of various hormones with well demonstrated deleterious impact, alteration of the immune response that may promote nosocomial infections and, finally, a decrease of respiratory muscle endurance that may compromise weaning from mechanical ventilation.

Various mechanisms contribute to sleep alteration in ICU patients, including intrinsic factors linked to disease severity, factors related to therapies such as mechanical ventilation and sedation, and environmental factors. Among environmental factors, light and noise are an unavoidable consequence of cares that strongly contribute to sleep alteration in ICU patients. It is of notice that few studies have focused on strategies to protect ICU patients against noise and light such as the systematic use of earplug and sleep mask. Although the benefit of earplug and sleep mask on sleep quality has been demonstrated in healthy subjects submitted to an environment similar to ICU, it has never been evaluated in ICU patients.

The aim of the study is to evaluate the benefit of earplug and sleep mask (designated as "protective strategy) on sleep architecture and quality in ICU patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Benefit of an Individual Protection Against Noise and Light on Sleep Quality in ICU Patients
Study Start Date : July 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
Experimental: earplug and sleep mask Device: earplug and sleep mask
Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs

No Intervention: control



Primary Outcome Measures :
  1. Duration of sleep stage 3 and 4 (polysomnography) [ Time Frame: day 2 ]
    Significant change of the duration of sleep stage 3 and 4 (polysomnography) in the "protective strategy group" (earplug and sleep mask) as compared to the control group (conventional strategy).


Secondary Outcome Measures :
  1. Nocturnal awakenings (polysomnography) [ Time Frame: Day 2 ]
    in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).

  2. Proportion of REM sleep (polysomnography) [ Time Frame: Day 2 ]
    in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).

  3. Total sleep time (polysomnography) [ Time Frame: Day 2 ]
    in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).

  4. Sleep time efficiency (polysomnography) [ Time Frame: Day 2 ]
    in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).

  5. level of anxiety and depression (HAD scale) [ Time Frame: At ICU discharge, an expected average of 3 weeks ]
    participants will be followed for the duration of ICU stay, a expected average of 3 weeks. comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).

  6. level of anxiety and depression (HAD scale) [ Time Frame: At day 90 ]
    comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).

  7. Incidence of posttraumatic stress disorder syndrome [ Time Frame: At ICU discharge, an expected average of 3 weeks ]
    participants will be followed for the duration of ICU stay, a expected average of 3 weeks. comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).

  8. Incidence of posttraumatic stress disorder syndrome [ Time Frame: At day 90 ]
    comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Admission in the ICU with expected duration of stay > 48hrs.
  • Level of sedation < 4 on Ramsay scale.
  • Interruption of sedation > 12 hrs
  • Analgesia with a maximal dose of morphine < 0.01 mg/Kg/h
  • Vasopressive therapy not exceeding 0.3 mg/Kg/min for epinephrine and 10 mg/Kg/min for dopamine.
  • Informed consent by patients or next of kind.

Exclusion criteria :

  • Known sleep disorder (apnea syndrome, narcolepsy, restless leg syndrome).
  • Central nervous disease that might impact sleep architecture or the interpretation of EEG recordings.
  • Severe liver encephalopathy (stage 3 or 4)
  • Ongoing sepsis
  • Pregnancy.
  • Age < 18 yrs.
  • No health insurance.

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 ClinicalTrials.gov identifier (NCT number): NCT02292134


Locations
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France
Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02292134    
Other Study ID Numbers: P081115
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sleep quality
Sleep architecture
Intensive care unit
Light
Noise
Earplug
Sleep mask