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REM Sleep Disruption and Its Potential Uses in Depression Management
Sponsor: WAKEZ HEALTH TECH ECOSYSTEM SRL
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
208
Start Date
2025-09-01
Completion Date
2025-11-30
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
REM-Contingent Smartwatch Haptic Stimulation
A pre-release iOS/watchOS system used Apple Watch accelerometry and photoplethysmography to classify consecutive 30-second epochs as wake, REM sleep, or non-REM sleep. In the experimental arm, two consecutive epochs classified as REM triggered wrist-delivered vibrotactile stimulation. Predefined haptic patterns included REM Shift L (2 Hz for 7 seconds, with a 20-second extended variant) and REM Shift M (2 Hz for 15 seconds). After each cue, the following sleep-stage estimate was reassessed; if REM persisted, additional stimulation could be delivered for up to five sets, followed by a minimum 10-minute suspension period. Stimulation was not delivered when the participant was classified as awake.
Smartwatch Sleep Monitoring and Smart Alarm
Participants in both study groups used the same pre-release iOS application and watchOS companion application for nocturnal sleep monitoring. The system collected wrist accelerometry and photoplethysmography data and generated algorithm-based sleep-stage estimates. A morning Smart Alarm was enabled by default in both groups and delivered a brief wrist haptic nudge consisting of click-type pulses at 2 Hz for 5 seconds.
Locations (2)
County Emergency Clinical Hospital Cluj-Napoca
Cluj-Napoca, Romania
WakeZ Health Tech Ecosystem SRL
Cluj-Napoca, Romania