Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation?

Hua-Wei Huang, Bo-Lu Zheng, Li Jiang, Zong-Tong Lin, Guo-Bin Zhang, Ling Shen, Xiu-Ming Xi, Hua-Wei Huang, Bo-Lu Zheng, Li Jiang, Zong-Tong Lin, Guo-Bin Zhang, Ling Shen, Xiu-Ming Xi

Abstract

Introduction: Sleep deprivation is common in critically ill patients in the intensive care unit (ICU). Noise and light in the ICU and the reduction in plasma melatonin play the essential roles. The aim of this study was to determine the effect of simulated ICU noise and light on nocturnal sleep quality, and compare the effectiveness of melatonin and earplugs and eye masks on sleep quality in these conditions in healthy subjects.

Methods: This study was conducted in two parts. In part one, 40 healthy subjects slept under baseline night and simulated ICU noise and light (NL) by a cross-over design. In part two, 40 subjects were randomly assigned to four groups: NL, NL plus placebo (NLP), NL plus use of earplugs and eye masks (NLEE) and NL plus melatonin (NLM). 1 mg of oral melatonin or placebo was administered at 21:00 on four consecutive days in NLM and NLP. Earplugs and eye masks were made available in NLEE. The objective sleep quality was measured by polysomnography. Serum was analyzed for melatonin levels. Subjects rated their perceived sleep quality and anxiety levels.

Results: Subjects had shorter total sleep time (TST) and rapid eye movement (REM) sleep, longer sleep onset latency, more light sleep and awakening, poorer subjective sleep quality, higher anxiety level and lower serum melatonin level in NL night (P <0.05). NLEE had less awakenings and shorter sleep onset latency (P <0.05). NLM had longer TST and REM and shorter sleep onset latency (P <0.05). Compared with NLEE, NLM had fewer awakenings (P = 0.004). Both NLM and NLEE improved perceived sleep quality and anxiety level (P = 0.000), and NLM showed better than NLEE in perceived sleep quality (P = 0.01). Compared to baseline night, the serum melatonin levels were lower in NL night at every time point, and the average maximal serum melatonin concentration in NLM group was significantly greater than other groups (P <0.001).

Conclusions: Compared with earplugs and eye masks, melatonin improves sleep quality and serum melatonin levels better in healthy subjects exposed to simulated ICU noise and light.

Trial registration: Chinese Clinical Trial Registry ChiCTR-IPR-14005458 . Registered 10 November 2014.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Melatonin levels in healthy subjects on the baseline night and on the simulated ICU noise and light (NL) night. Serum melatonin levels were measured in all subjects on baseline and NL nights for 9 h from 20:50 to 06:00. The graph depicts the nocturnal serum melatonin concentration. Points represent mean ± SD. Solid circles, healthy subjects on the baseline night; solid triangles, healthy subjects on the NL night: *P <0.05 at 0:00, 01:00, 02:00, 03:00 and 04:00 for comparison of the baseline and the NL night.
Figure 3
Figure 3
Serum melatonin concentration time profiles for different study conditions on night 8. Serum melatonin levels were measured at the end of the study period for 9 h from 20:50 to 06:00. The graph depicts the nocturnal serum melatonin concentration. Points represent mean ± SD. Open circles, healthy subjects on simulated ICU noise and light (NL); solid circles, healthy subjects on NL plus placebo (NLP); solid triangles, healthy subjects on NL plus use of earplugs and eye masks (NLEE); solid squares, healthy subjects on NL plus melatonin (NLM): *P <0.05 at 22:00, 23:00, 0:00, 01:00, 02:00 and 03:00, respectively, for comparison between the NLM and NL nights.

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