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

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.