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Clinical Trial

REM Sleep Disruption and Its Potential Uses in Depression Management

NCT: NCT07891806 · COMPLETED

NCT IDNCT07891806
StatusCOMPLETED
Start Date2025-09-01
Completion2025-11-30
SponsorWAKEZ HEALTH TECH ECOSYSTEM SRL (INDUSTRY)
First posted
Last updated

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.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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