A Phase 3 interventional study of earplug and sleep mask in Intensive Care Unit Patients, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-17.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria :
Device: earplug and sleep mask
Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs
Duration of sleep stage 3 and 4 (polysomnography)
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
Nocturnal awakenings (polysomnography)
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Time frame: Day 2
Proportion of REM sleep (polysomnography)
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Time frame: Day 2
Total sleep time (polysomnography)
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Time frame: Day 2
Sleep time efficiency (polysomnography)
in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Time frame: Day 2
level of anxiety and depression (HAD scale)
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 ICU discharge, an expected average of 3 weeks
level of anxiety and depression (HAD scale)
comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
Time frame: At day 90
Incidence of posttraumatic stress disorder syndrome
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 ICU discharge, an expected average of 3 weeks
Incidence of posttraumatic stress disorder syndrome
comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
Time frame: At day 90
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris