An interventional study of REM-Contingent Smartwatch Haptic Stimulation and Smartwatch Sleep Monitoring and Smart Alarm in Depression / Major Depressive Disorder and Depressed Mood, sponsored by WAKEZ HEALTH TECH ECOSYSTEM SRL. Completed at 2 sites in Romania. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by WAKEZ HEALTH TECH ECOSYSTEM SRL · Not applicable, Interventional, and Treatment
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.
This was a single-center, randomized, parallel-group superiority study conducted in adults aged 18-65 years with clinically significant depressive symptoms. A total of 208 participants were randomized in a 1:1 ratio to an active intervention group or a monitoring-only control group.
Participants used an iPhone application together with an Apple Watch companion application during sleep. The system continuously processed wrist accelerometry and photoplethysmography data and classified consecutive sleep epochs as wake, REM sleep, or non-REM sleep. In the active group, detection of probable REM sleep triggered brief vibrotactile stimulation at the wrist. The sleep-stage estimate was reassessed after each stimulation event and additional stimulation could be delivered according to a predefined escalation algorithm if REM classification persisted. The control group underwent the same sleep monitoring but did not receive REM-contingent night-time stimulation. A morning Smart Alarm haptic function was available in both groups.
The main clinical objective was to determine whether REM-contingent haptic stimulation was associated with a reduction in depressive symptom severity compared with monitoring alone. The primary outcome was the baseline-adjusted between-group difference in final Montgomery-Åsberg Depression Rating Scale (MADRS) score. The Beck Depression Inventory-II (BDI-II) served as a secondary clinical outcome and was also assessed repeatedly during the intervention period. Additional analyses evaluated wearable-derived sleep architecture, REM-related measures, intervention delivery, adherence, and tolerability. Outcome assessors were blinded to treatment allocation.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 208 is above the median of 84 across 6,869 interventional studies indexed under Depression.
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Participants used the study iPhone and Apple Watch applications for sleep monitoring and received REM-contingent vibrotactile stimulation during algorithm-identified probable REM sleep. Sleep stage was estimated in real time from wrist accelerometry and photoplethysmography. A morning Smart Alarm haptic function was also available, as in the Control arm.
Device: REM-Contingent Smartwatch Haptic Stimulation · Device: Smartwatch Sleep Monitoring and Smart Alarm
Participants used the same study iPhone and Apple Watch applications for sleep monitoring but did not receive REM-contingent night-time haptic stimulation. The same morning Smart Alarm haptic function available to the Experimental arm was also available in this group.
Device: Smartwatch Sleep Monitoring and Smart Alarm
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.
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.
Final Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Clinician-rated depressive symptom severity measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). The primary analysis compared final MADRS scores between the experimental and control groups using analysis of covariance (ANCOVA), adjusted for baseline MADRS score. Lower MADRS scores indicate lower depressive symptom severity.
Time frame: Baseline and final post-intervention assessment, within 40 days after completion of the intervention.
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Plan to share: Yes — De-identified individual participant data underlying the primary and secondary clinical outcomes will be made available as supplementary material accompanying the primary publication.
Time frame: Beginning upon publication of the primary study results and remaining available for as long as the supplementary materials accompanying the publication remain publicly accessible.
Access criteria: De-identified individual participant data underlying the primary and secondary clinical outcomes will be made publicly available as supplementary material accompanying the primary publication. No additional approval or data-use agreement will be required to access these data. Additional non-public study data will not be included in this sharing plan.
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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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