Impact of earplugs and eye mask on sleep in critically ill patients: a prospective randomized study

Alexandre Demoule, Serge Carreira, Sophie Lavault, Olivier Pallanca, Elise Morawiec, Julien Mayaux, Isabelle Arnulf, Thomas Similowski, Alexandre Demoule, Serge Carreira, Sophie Lavault, Olivier Pallanca, Elise Morawiec, Julien Mayaux, Isabelle Arnulf, Thomas Similowski

Abstract

Background: Poor sleep is common in intensive care unit (ICU) patients, where environmental factors contribute to reduce and fragment sleep. The objective of this study was to evaluate the impact of earplugs and eye mask on sleep architecture in ICU patients.

Methods: A single-center randomized controlled trial of 64 ICU patients was conducted from July 2012 to December 2013. Patients were randomly assigned to sleep with or without earplugs and an eye mask from inclusion until ICU discharge. Polysomnography was performed on the first day and night following inclusion. The primary outcome was the proportion of stage N3 sleep over total sleep time. Secondary outcomes were other descriptors of sleep and major outcome variables.

Results: In the intervention group, nine (30%) patients did not wear earplugs all night long. The proportion of N3 sleep was 21 [7-28]% in the intervention group and 11 [3-23]% in the control group (p = 0.09). The duration of N3 sleep was higher among the patients in the intervention group who wore earplugs all night long than in the control group (74 [32-106] vs. 31 [7-76] minutes, p = 0.039). The number of prolonged awakenings was smaller in the intervention group (21 [19-26] vs. 31 [21-47] in the control group, p = 0.02). No significant difference was observed between the two groups in terms of clinical outcome variables.

Conclusions: Earplugs and eye mask reduce long awakenings and increase N3 duration when they are well tolerated.

Trial registration: ClinicalTrials.gov, NCT02292134 . Registered on 21 Nov 2013.

Keywords: Delirium; Earplugs; Eye mask; Intensive care; Polysomnography; Sleep.

Conflict of interest statement

Ethics approval and consent to participate

Human research ethics committee approval for the study was provided by the Comité de Protection des Personnes - Ile de France 6. Patients or their next of kin gave informed consent.

Consent for publication

Not applicable.

Competing interests

AD reports receiving personal fees from Maquet; grants, personal fees, and nonfinancial support from Covidien; personal fees from MSD; grants and nonfinancial support from Philips; nonfinancial support from Dräger; grants and personal fees from ResMed; and personal fees from Fisher & Paykel (all outside the submitted work). IA reports receiving personal fees from UCB Pharma outside the submitted work. TS reports receiving personal fees from Almirall France, personal fees from AstraZeneca France and corporate personal fees from Boehringer Ingelheim France, personal fees from GlaxoSmithKline France, personal fees from Invacare, personal fees from Mundipharma, personal fees and nonfinancial support from Novartis France, personal fees from Pfizer France, grants and personal fees from Pierre Fabre Médicaments, personal fees from Takeda, personal fees from Teva Pharma, and personal fees from Lungpacer Medical Inc., all outside the submitted work. The other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flowchart

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