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Life sciences · Interventional Study
ClinicalTrials.gov · October 23, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07891806). This is a study registration, not published results. Lead sponsor: WAKEZ HEALTH TECH ECOSYSTEM SRL. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 208 participants (ACTUAL). Conditions: Depression / Major Depressive Disorder, Depressed Mood. Interventions: DEVICE: REM-Contingent Smartwatch Haptic Stimulation; DEVICE: Smartwatch Sleep Monitoring and Smart Alarm. Primary outcome measures: Final Montgomery-Åsberg Depression Rating Scale (MADRS) Score , Baseline and final post-intervention assessment, within 40 days after completion of the intervention.. Brief summary: This randomized study evaluated whether brief wrist vibrations delivered through an Apple Watch during algorithm-identified rapid eye movement (REM) sleep could reduce depressive symptoms over approximately four weeks. Adults with clinically significant depressive symptoms were assigned to either REM-contingent haptic stimulation or a monitoring-only control condition. Both groups used the same iPhone and Apple Watch applications and received the same morning Smart Alarm function; only the intervention group received night-time haptic stimulation during probable REM sleep. Sleep stages were estimated in real time using wrist accelerometry and photoplethysmography. Depressive symptoms were assessed using clinician-rated and self-reported measures, with the Montgomery-Åsberg Depression Rating Scale (MADRS) as the primary clinical outcome and the Beck Depression Inventory-II (BDI-II) as a secondary outcome. Sleep architecture, treatment exposure, adherence, and tolerability were also evaluated.