Improving Sleep Quality in ICU Patients

NCT ID: NCT02292134

Last Updated: 2014-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Intensive Care Unit Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

earplug and sleep mask

Group Type: EXPERIMENTAL

earplug and sleep mask

Intervention Type: DEVICE

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

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

earplug and sleep mask

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Paris, , France

Countries

France

References

Demoule A, Carreira S, Lavault S, Pallanca O, Morawiec E, Mayaux J, Arnulf I, Similowski T. Impact of earplugs and eye mask on sleep in critically ill patients: a prospective randomized study. Crit Care. 2017 Nov 21;21(1):284. doi: 10.1186/s13054-017-1865-0.

Reference Type: DERIVED

PMID: 29157258 (View on PubMed)

Other Identifiers

P081115

Identifier Type: -

Identifier Source: org_study_id