Improving Sleep Quality in ICU Patients (EARS)

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

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Patients
• Intervention / Treatment: Device: earplug and sleep mask

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
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

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Estimate): November 17, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Intensive care unit; Sleep quality; Light; Noise; Sleep architecture; Earplug; Sleep mask
• Other Study ID Numbers: P081115