Improving Sleep Quality in ICU Patients (EARS)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Intensive Care Unit Patients

Treatments

Device: earplug and sleep mask

Study type

Interventional

Funder types

Other

Identifiers

NCT02292134

P081115

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.