Depression / Major Depressive DisorderNCT07891806
REM Sleep Disruption and Its Potential Uses in Depression Management
A study testing REM-Contingent Smartwatch Haptic Stimulation and Smartwatch Sleep Monitoring and Smart Alarm in people with Depression / Major Depressive Disorder and Depressed Mood, run by WAKEZ HEALTH TECH ECOSYSTEM SRL at 2 sites in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression / Major Depressive Disorder, Depressed Mood
- What is being tested?
- REM-Contingent Smartwatch Haptic Stimulation and Smartwatch Sleep Monitoring and Smart Alarm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 2 sitesRomania
- Study dates
- 1 Sep 2025to 30 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, inclusive; all genders.
- Apple ecosystem user, with iPhone as the minimum requirement.
- Clinical diagnosis of depression/major depressive disorder or clinician administered MADRS score at least 8.
- Signed informed consent.
Who cannot join
- Use of any other medication considered likely to interact with REM sleep.
- Presence of another relevant psychiatric or psychological disorder, including schizophrenia, other affective disorders, substance abuse/addiction, dementia, PTSD, or another clinically relevant disorder.
- Epilepsy.
- Chronic debilitating disease, including significant cardiac, pulmonary, hepatic, or renal disease.
- Known diagnosis of obstructive sleep apnea, REM sleep behavior disorder, or narcolepsy.
- Regular circadian-rhythm disruption, including shift work or treatment interfering with circadian rhythm or sleep cycles, such as prazosin.
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
County Emergency Clinical Hospital Cluj-Napoca
Cluj-Napoca
WakeZ Health Tech Ecosystem SRL
Cluj-Napoca
About this study
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.
Read the detailed description
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.
- Being tested
- REM-Contingent Smartwatch Haptic Stimulation, Smartwatch Sleep Monitoring and Smart Alarm
- Keywords
- REM sleep, depression, wearable devices, haptic stimulation, digital therapeutics, randomized controlled trial, sleep architecture
- Medical subject headings
- Depression, Depressive Disorder, Major, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REM-Contingent Smartwatch Haptic StimulationDevice
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 AlarmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| REM-Contingent Haptic Stimulation | Experimental | 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. Receives: Device: REM-Contingent Smartwatch Haptic Stimulation; Device: Smartwatch Sleep Monitoring and Smart Alarm |
| Monitoring-Only Control | Other | 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. Receives: Device: Smartwatch Sleep Monitoring and Smart Alarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and final post-intervention assessment, within 40 days after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Sep 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression / Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- WAKEZ HEALTH TECH ECOSYSTEM SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergency County Hospital Cluj-Napoca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891806
- Sponsor's protocol ID
- #2024-241218-002
- Other IDs
- SMIS 308944
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary clinical outcomes will be made available as supplementary material accompanying the primary publication.