Improving Sleep Quality in ICU Patients

Intensive Care Unit Patients Clinical Trial

— EARS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292134
• Other study ID #: P081115
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2013
• Last updated: November 14, 2014
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intensive Care Unit Patients

Intervention

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

Locations

Country	Name	City	State
France	Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Nocturnal awakenings (polysomnography)	in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).	Day 2	No
Secondary	Proportion of REM sleep (polysomnography)	in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).	Day 2	No
Secondary	Total sleep time (polysomnography)	in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).	Day 2	No
Secondary	Sleep time efficiency (polysomnography)	in the "protective strategy group" (earplug and sleep mask) compared to the control group (conventional strategy).	Day 2	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No