Eye-mask and Earplugs Compared with Sleep Advice Leaflet to Improve Night Sleep Duration in Pregnancy: a Randomized Controlled Trial.

Study Objectives: To evaluate at-home use of eye-mask and earplugs (EMEP) versus sleep hygiene advice leaflet (AL) on actigraphy-derived night sleep duration in sleep-deprived pregnant women. Methods: A randomized controlled trial was conducted in the antenatal clinic of University Malaya Medical Centre from June 2021 to June 2022. Women at 34-36 weeks gestation with self-reported night sleep duration <= 6 hours were recruited. Participants wore an actigraphy device at night for seven consecutive nights (Observation/Baseline week). Only women whose actigraphy-derived night sleep duration was confirmed to be <= 360 minutes were randomized to use EMEP or AL. Actigraphy was continued for another week (Intervention week). Primary outcome was change in actigraphy-derived night sleep duration from observation to intervention week across trial arms. Secondary outcomes include participants' sleep quality, labor, and neonatal outcome. Comparisons were by Student t-test, Mann-Whitney U test, and chi-square test. Results: A total of 210 women were randomized: 105 each to EMEP and AL. The increase in night sleep duration over baseline was significantly longer with both EMEP (mean +/- SD) 23 +/- 41 minutes, p < .001, and AL 10 +/- 35 minutes, p = .007. Night sleep duration was longer by 12.9 (95% CI = 2.2 to 23.7) minutes, p = .019 with EMEP over AL. Sleep quality (Global Pittsburgh Sleep Quality Index score) was significantly improved with EMEP (mean +/- SD) -2.0 +/- 2.5, p < .001, but not with AL -0.3 +/- 2.2, p = .246. Labor and neonatal outcomes were not significantly different. Conclusion: EMEP significantly lengthened night sleep duration in sleep-deprived women in late pregnancy and is superior to AL.