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