Clinical trial NCT02292134: Improving Sleep Quality in ICU Patients
Official title: Benefit of an Individual Protection Against Noise and Light on Sleep Quality in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intensive Care Unit Patients
Keywords: Sleep quality
Sleep architecture
Intensive care unit
Light
Noise
Earplug
Sleep mask
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Duration of sleep stage 3 and 4 (polysomnography)
timeFrame: day 2
Secondary outcomes:
measure: Nocturnal awakenings (polysomnography)
timeFrame: Day 2
measure: Proportion of REM sleep (polysomnography)
timeFrame: Day 2
measure: Total sleep time (polysomnography)
timeFrame: Day 2
measure: Sleep time efficiency (polysomnography)
timeFrame: Day 2
measure: level of anxiety and depression (HAD scale)
timeFrame: At ICU discharge, an expected average of 3 weeks
measure: level of anxiety and depression (HAD scale)
timeFrame: At day 90
measure: Incidence of posttraumatic stress disorder syndrome
timeFrame: At ICU discharge, an expected average of 3 weeks
measure: Incidence of posttraumatic stress disorder syndrome
timeFrame: At day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6
Study officials:
References:
citation: Demoule A, Carreira S, Lavault S, Pallanca O, Morawiec E, Mayaux J, Arnulf I, Similowski T. Impact of earplugs and eye mask on sleep in critically ill patients: a prospective randomized study. Crit Care. 2017 Nov 21;21(1):284. doi: 10.1186/s13054-017-1865-0.