Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)

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.

Inclusion criteria

Subjects must meet ALL the following conditions to be eligible to participate in the study:

• Subject is age ≥ 22 years and ≤ 75 years.
• Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
• Subject is willing and able to provide informed consent.
• Subject has the ability to read and understand the instructions for the study.
• Subject is willing to adhere to study procedures.
• Subject is willing to undergo full night diagnostic PSG study, as prescribed.

Exclusion criteria

Subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present:

• Subject has a pacemaker.
• Subject has undergone a heart transplant.
• Subject is undergoing a full night C-PAP titration study.