Improving Sleep Quality in ICU Patients

Phase 3

Completed

• Conditions: Intensive Care Unit Patients
• Interventions: Device: earplug and sleep mask

• Registration Number: NCT02292134
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2012-07
• Status Verified: 2013-11
• Study First Submitted: 2013-11-21
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted QC: 2014-11-14
• Last Update Submitted: 2014-11-14
• Study First Posted: 2014-11-17
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
earplug and sleep mask	earplug and sleep mask	-

Primary Outcome Measures

Name	Time	Method
Duration of sleep stage 3 and 4 (polysomnography)	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).

Secondary Outcome Measures

Name	Time	Method
Nocturnal awakenings (polysomnography)	Day 2	in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Proportion of REM sleep (polysomnography)	Day 2	in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Total sleep time (polysomnography)	Day 2	in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
Sleep time efficiency (polysomnography)	Day 2	in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).
level of anxiety and depression (HAD scale)	At day 90	comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).
Incidence of posttraumatic stress disorder syndrome	At day 90	comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).

Trial Locations

Locations (1)

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