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.

Comparison of the systemic availability of fluticasone propionate in healthy volunteers and patients with asthma.

Objectives: The aim of this analysis was to compare the systemic exposure to inhaled fluticasone propionate (FP) after administration of either single or repeated dose regimens via dry powder and metered-dose inhalers in patients with asthma and healthy volunteers.

Background: The pharmacokinetics of FP, a topically active glucocorticoid administered by inhalation for the treatment of asthma and rhinitis, are well characterised in healthy volunteers. As asthma is characterised by pathophysiological changes in the lung, it may be inappropriate to use data from studies in healthy volunteers to predict the deposition and absorption of FP in patients with asthma.