Evaluating Dreem wearable EEG headband for wake and sleep assessments in narcolepsy type 1

Music City Center 

Narcolepsy type 1 (NT1) is a neurological disorder caused by orexin deficiency and is characterized by excessive daytime sleepiness, cataplexy, hallucinations, sleep paralysis and disrupted nocturnal sleep. In-lab polysomnogaphy (PSG) and multiple sleep latency tests (MSLT) are recommended for assessments of pathological sleep for NT1 diagnosis, requiring substantial patient time and trained personnel costs. The Dreem 3S (D3S) headband is an FDA-cleared device for ambulatory EEG-based sleep staging and is operable by patients at home. The ongoing D3KAH study (NCT06531876) evaluates D3S utility in subjects with central disorders of hypersomnolence, including NT1. An interim analysis (IA) of 15 NT1 completers (as of 30 January 2025) assesed data from at-home D3S monitoring over 6 nights and a 24-hour period, and 2 nights of concurrent in-lab PSG and D3S monitoring. We present statistical methods to assess wear adherence, sleep staging performance, and explore the potential utility of repeated sleep assessment at home. All primary endpoints met pre-defined success criteria at IA. Primary, secondary, and exploratory endpoints at full readout will be presented.