Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6
Paris, 75013, France
NCT Number: NCT02292134
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Paris, 75013, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs
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).
Time frame: Day 2
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Time frame: Day 2
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Time frame: Day 2
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Time frame: Day 2
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
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).
Time frame: At day 90
comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
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).
Time frame: At day 90
comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
Assistance Publique - Hôpitaux de Paris
Other
Benefit of an Individual Protection Against Noise and Light on Sleep Quality in ICU Patients
Acronym: EARS
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