Zaki Milhem

WakeZ is a Cluj-Napoca (Romania) digital health startup building a wearable-first platform that turns everyday sleep into actionable mental-health signals and low-burden, sleep-time intervention. Our core hypothesis is that depression is reflected in REM-sleep dynamics (“REM disinhibition”), and that these signals can be captured at scale with consumer wearables and then modulated safely through closed-loop haptics. WakeZ runs on Apple Watch + iPhone. During the night, the watch streams accelerometry and photoplethysmography (heart-rate) signals; a polysomnography-aligned machine-learning pipeline performs epoch-level sleep staging and estimates REM features in real time. These features are used in two ways: (1) longitudinal, within-person monitoring that flags meaningful shifts in REM architecture consistent with elevated depressive-symptom burden, and (2) stage-contingent vibrotactile pulses delivered during detected REM to gently fragment REM micro-architecture without waking the user, aiming to support symptom relief while remaining passive and adherence-friendly. Our clinical program includes multi-night wearable datasets and published evidence that wearable-derived REM latency and REM proportion are strongly associated with depressive symptoms, with the two variables jointly explaining a large share of BDI variance in an adult cohort. We have also completed an at-home randomized study of REM-contingent haptics (manuscript under peer review) showing meaningful improvements in self-reported depressive symptoms versus control. WakeZ is advancing toward EU MDR Class I compliance, with privacy-by-design (GDPR-aligned pseudonymization) and a roadmap for larger prospective validation and post-market surveillance. We also offer a clinical-trial mode for sponsors and clinics, enabling remote sleep phenotyping and standardized digital endpoints. WakeZ does not provide a psychiatric diagnosis; it supports monitoring and adjunctive self-management.