Objective multi-night sleep monitoring at home: variability of sleep parameters between nights and implications for the reliability of sleep assessment in clinical trials.

Study Objectives: In-laboratory polysomnography is the current gold standard for objective sleep measurements in clinical trials, but this does not capture night-to-night variability in sleep parameters. This study analyzed variability in sleep parameters recorded over multiple nights of sleep in an ecological setting using a portable sleep monitor and then estimated the minimum sample sizes required to reliably account for inter- and intra-individual variability in sleep parameters.

Methods: Participants were males who self-reported the absence of sleep disorders, and used a sleep monitoring device (Dreem Headband, Dreem, France) over multiple nights of sleep.