Eye-mask and earplugs as sleep aid on glucose metabolism in sleep-deprived pregnancy: a randomized controlled trial.

backgroundGestational diabetes is associated with short sleep duration. Both conditions are common in pregnancy, especially in later pregnancy. Eye mask and earplugs when used at home in sleep-deprived pregnancy has been shown to extend nocturnal sleep. Data is sparse on the effect of sleep aids on glucose metabolism through extending sleep. We sought to evaluate use of eye-mask and earplugs on fasting and 2-hour plasma glucose levels at routine oral glucose tolerance test (OGTT) and on actigraph-derived night sleep duration in women with sleep-deprived pregnancy.

methodsA randomized trial was conducted in a university hospital in Malaysia from July 2021 to August 2022. Sleep-deprived (≤ 7 h night sleep duration) women, on being scheduled for routine OGTT for gestational diabetes screening were enrolled. Participants were randomized to the use of eye-mask and earplugs as sleep aid or no intervention in the week prior to OGTT appointment. All participants were asked to wear the actigraph watch during night sleep in the week prior to OGTT. Pittsburgh Sleep Quality Index (PSQI) data was also obtained at enrollment and at OGTT. The primary outcome was fasting and 2-hour glucose levels at OGTT and actigraph-derived night sleep duration. Secondary outcomes were actigraph-derived wakening after sleep onset, sleep efficiency, and PSQI-derived sleep quality and self-reported night sleep duration. The t test, Mann-Whitney U test, Chi square test, and Fisher exact test were used as appropriate for the data.

results240 women were randomized; 120 to each intervention. Data on OGTT results were available from 116 to 117 participants and on actigraph-derived sleep data from 100 to 103 participants for eye-mask and earplugs vs. no intervention arms respectively. The primary outcome of fasting glucose level was mean ± standard deviation (mmol/l ) 4.4 ± 0.5 vs. 4.3 ± 0.4, mean difference (95% CI) 0.03 (-0.86 to 1.46) p = 0.611, 2-hour level was 6.3 ± 1.4 vs. 6.4 ± 1.3, mean difference (95% CI) -0.11 (-0.45 to 0.23) p = 0.536, and total night sleep duration (minutes) 347 ± 50 vs. 349 ± 47, mean difference (95% CI) -2.6 (-16.0 to 10.9) p = 0.707for eye-mask and earplugs vs. no intervention arms respectively. Secondary outcomes were also not significantly different.

conclusionOne-week use of eye-mask and earplugs as a sleep aid in women with sleep-deprived pregnancy does not decrease glucose levels at oral glucose tolerance test or extend actigraph-derived sleep duration. ETHICS OVERSIGHT: This trial was approved by the Medical Research Ethics Committee of University Malaya Medical Centre (UMMC) on July 1, 2021 (reference number MREC ID NO: 202157 - 10120). CLINICAL

trial registrationThis study was registered in ISRCTN registry on July 14, 2021, with trial identification number: ISRCTN 17,526,076, http://www.isrctn.com/ISRCTN17526076 .