Improving Sleep Quality in ICU Patients

Study Overview
=================
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.

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.

Official Title
-----------------
Benefit of an Individual Protection Against Noise and Light on Sleep Quality in ICU Patients

Conditions
-----------------
Intensive Care Unit Patients

Intervention / Treatment
-----------------
* Device: earplug and sleep mask


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: earplug and sleep mask<br> | Device: earplug and sleep mask<br>* Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs<br>|
| No Intervention: control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal awakenings (polysomnography) | in the protective strategy group (earplug and sleep mask) compared to the control group (conventional strategy). | Day 2 | 
| Proportion of REM sleep (polysomnography) | in the protective strategy group (earplug and sleep mask) compared to the control group (conventional strategy). | Day 2 | 
| Total sleep time (polysomnography) | in the protective strategy group (earplug and sleep mask) compared to the control group (conventional strategy). | Day 2 | 
| Sleep time efficiency (polysomnography) | in the protective strategy group (earplug and sleep mask) compared to the control group (conventional strategy). | 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). | 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). | 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). | 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). | At day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Light, Sleep quality, Sleep architecture, Intensive care unit, Noise, Earplug, Sleep mask