Pilot evaluation of a consumer wearable device to assess sleep in a clinical polysomnography trial of suvorexant for treating insomnia in patients with Alzheimer's disease.

Abstract

The orexin receptor antagonist suvorexant was previously reported to significantly improve total sleep time (TST), by 28min per night versus placebo after 4weeks, in a sleep laboratory polysomnography (PSG) study of patients with Alzheimer's disease and insomnia. The study included an exploratory evaluation of a consumer-grade wearable "watch" device for assessing sleep that we report on here. Participants who met diagnostic criteria for both probable Alzheimer's disease dementia and insomnia were randomized to suvorexant 10-20mg (N=142) or placebo (N=143) in a double-blind, 4-week trial. Patients were provided with a consumer-grade wearable watch device (Garmin vívosmart® HR) to be worn continuously. Overnight sleep laboratory PSG was performed on three nights: screening, baseline and Night 29 (last dose). Watch treatment effects were assessed by change-from-baseline in watch TST at Week 4 (average TST per night). We also analysed Night 29 data only, with watch data restricted to the PSG recording time. In the 193 participants included in the Week 4 watch analysis (suvorexant=97, placebo=96), the suvorexant-placebo difference in watch TST was 4min (p=.622). In patients with usable data for both assessments at the baseline and Night 29 PSG (suvorexant=57, placebo=50), the watch overestimated TST compared to PSG (e.g., placebo baseline=412min for watch and 265min for PSG) and underestimated change-from-baseline treatment effects: the suvorexant-placebo difference was 20min for watch TST (p=.405) and 35min for PSG TST (p=.057). These findings show that the watch was less sensitive than PSG for evaluating treatment effects on TST.