NCT07891806Completed
REM Sleep Disruption and Its Potential Uses in Depression Management
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 208 (actual)
- First submitted
- 8 Oct 2026
- Start date
- Sept 2025
- Primary completion date
- Nov 2025
- Lead sponsor
- WAKEZ HEALTH TECH ECOSYSTEM SRL
- Diseases
- Depression
- NCT number
- NCT07891806
What you commit to
- Study type: Interventional
- Participants enrolled: 208
- From Sept 2025 to the primary completion date, Nov 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any other medication considered likely to interact with REM sleep.
Other illness
- 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.
Other
- Regular circadian-rhythm disruption, including shift work or treatment interfering with circadian rhythm or sleep cycles, such as prazosin.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| WakeZ Health Tech Ecosystem SRL Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| County Emergency Clinical Hospital Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.