1117 Oral Microemulsion Gel Shows Improvements in Objective and Perceived Sleep

Abstract Introduction More empirical research is needed on the effectiveness of ingestible consumer sleep products. This study investigated the effects of a gel-delivered sleep supplement on both objectively measured and perceived sleep in a non-clinical sample of adults. Methods Healthy adults (58% male, ages 40-73, mean age=56) with difficulty falling asleep or staying asleep participated in a 6-week field study, using a pre-post intervention design. During the 3-week baseline period, participants tracked their sleep at home without intervention. During the 3-week intervention period, 30-minutes before bedtime, participants ingested a gel including a blend of melatonin, L-Theanine, magnesium, calcium, vitamin B6, L-Glycine, 5-HTP, lemon balm extract, and GABA. Sleep was measured objectively using a PSG-validated, non-contact biomotion device, SleepScore Max, every night and by daily and pre-post self-report. Multilevel regression and paired t-tests were used to test for statistical significance. Results There were 822 nights of tracked sleep across 26 participants. Compared to baseline sleep, objective sleep measurements showed decreased sleep onset latency (p=.019); increased deep sleep, both in duration (p.001) and proportion of the night (p=.001); fewer awakenings (p=.003); decreased wake after sleep onset, both in duration (p.001) and proportion of the night (p=.001); and increased sleep efficiency (p.001) and sleep maintenance (p=.001). Improvements also were observed in SleepScore (p=.010), a measure of overall sleep quality, and BodyScore (p=.005), a measure of deep sleep. Self-report measures revealed improvements in a variety of outcomes compared to baseline: feeling adequately sleepy during bedtime more nights per week (p=.014); feeling it was easier to fall asleep (p.033); falling asleep in the preferred amount of time more nights per week (p=.006); feeling better able to sleep through the night without waking (p=.023); perceiving better overall sleep quality (p=.014); feeling satisfied with sleep more days per week (p=.007); and feeling well rested more days per week (p=.048). Conclusion In this sample of healthy adults, both objectively measured sleep and self-reported sleep improved when using the gel compared to baseline sleep without intervention. Support (if any) HealthyCell