This is a two (2)-phase, single-arm, prospective, non-significant risk, multi-center trial where each enrolled subject's data will be used for the development of MEB-001.
Study Population:
Subjects who are at least 22 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbances and sign an informed consent form (ICF) will be evaluated for participation in this study.
The selection of the population involved in the study will consider the geographic diversity needed to obtain a representative sample of the intended use population. Centers will be selected to secure geographic and clinical diversity across the USA to obtain a representative distribution of the intended patient population.
All patients undergoing PSG due to primary or secondary sleep disorders, which include, but are not limited to, Sleep-Related Movement Disorders, Sleep-Related Breathing Disorders, Intrinsic and Extrinsic Circadian Rhythm Sleep-Wake Disorders, Hypersomnia, Parasomnia, and Insomnia, will be consecutively recruited, according to the inclusion/exclusion criteria.