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Completed

NCT Number: NCT02292134

Improving 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

earplug and sleep mask

Device

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

Primary outcomes

  1. Duration of sleep stage 3 and 4 (polysomnography)

    Time frame: 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 outcomes

  1. Nocturnal awakenings (polysomnography)

    Time frame: Day 2

    in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).

  2. Proportion of REM sleep (polysomnography)

    Time frame: Day 2

    in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).

  3. Total sleep time (polysomnography)

    Time frame: Day 2

    in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).

  4. Sleep time efficiency (polysomnography)

    Time frame: Day 2

    in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).

  5. level of anxiety and depression (HAD scale)

    Time frame: At ICU discharge, an expected average of 3 weeks

    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).

  6. level of anxiety and depression (HAD scale)

    Time frame: At day 90

    comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).

  7. Incidence of posttraumatic stress disorder syndrome

    Time frame: At ICU discharge, an expected average of 3 weeks

    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).

  8. Incidence of posttraumatic stress disorder syndrome

    Time frame: At day 90

    comparison between the "protective strategy group" (earplug and sleep mask) and the control group (conventional strategy).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EARS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 17, 2014
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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