Skip to content

Improving Sleep Quality in ICU Patients

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02292134
Acronym
EARS
Enrollment
64
Registered
2014-11-17
Start date
2012-07-31
Completion date
2013-12-31
Last updated
2014-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Patients

Keywords

Sleep quality, Sleep architecture, Intensive care unit, Light, Noise, Earplug, Sleep mask

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.

Interventions

DEVICEearplug and sleep mask

Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of sleep stage 3 and 4 (polysomnography)day 2Significant 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

MeasureTime frameDescription
Proportion of REM sleep (polysomnography)Day 2in the protective strategy group (earplug and sleep mask) compared to the control group (conventional strategy).
Total sleep time (polysomnography)Day 2in the protective strategy group (earplug and sleep mask) compared to the control group (conventional strategy).
Nocturnal awakenings (polysomnography)Day 2in the protective strategy group (earplug and sleep mask) compared to the control group (conventional strategy).
level of anxiety and depression (HAD scale)At ICU discharge, an expected average of 3 weeksparticipants 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).
Incidence of posttraumatic stress disorder syndromeAt ICU discharge, an expected average of 3 weeksparticipants 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).
Sleep time efficiency (polysomnography)Day 2in the protective strategy group (earplug and sleep mask) compared to the control group (conventional strategy).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026