Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy

Diagnosing hypersomnia conditions (including narcolepsy type 1 \[NT1\], narcolepsy type 2 \[NT2\], and idiopathic hypersomnia \[IH\]) and differentiating them from other conditions is often challenging as symptoms including excessive daytime sleepiness, daytime napping, and disturbed nocturnal sleep are nonspecific and current diagnostic tests are limited. Unfortunately, patients with hypersomnia often demonstrate a discrepancy between self-reported sleep duration and quantitative assessment. This complicates both diagnosis and management, as objective sleep assessment is typically not available over multiple periods. A more natural approach would be to monitor sleep and wakefulness serially and with monitoring, including assessment of total sleep time, rapid eye movement (REM) latency, daytime sleep attacks, daytime sleep/nap duration, and consolidated/non-consolidated nocturnal sleep. This validation study evaluates the ability of Dreem 3S to capture multiple days of continuous sleep and wake measures in subjects with hypersomnia, particularly in NT1. Primary outcomes will include usability of Dreem 3S by patients with hypersomnia, patient compliance with longitudinal data collection using Dreem 3S at-home, and fidelity of sleep staging of Dreem 3S data to synchronously recorded gold-standard nocturnal PSG and MSLT. Dreem 3S is an FDA cleared class II medical device, under the OLZ/OLV (PSG devices) product codes for home sleep staging in patients with disturbed sleep.