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Completed
NCT07891806
REM Sleep Disruption and Its Potential Uses in Depression Management
Conditions: Depression / Major Depressive Disorder, Depressed Mood
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 208
Sponsor: WAKEZ HEALTH TECH ECOSYSTEM SRL
Location: County Emergency Clinical Hospital Cluj-Napoca Cluj-Napoca
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.
Eligibility Criteria
Inclusion criteria
1. Age 18-65 years, inclusive; all genders.
2. Apple ecosystem user, with iPhone as the minimum requirement.
3. Clinical diagnosis of depression/major depressive disorder or clinician administered MADRS score at least 8.
4. Signed informed consent.
Exclusion Criteria:
1. Use of any other medication considered likely to interact with REM sleep.
2. Presence of another relevant psychiatric or psychological disorder, including schizophrenia, other affective disorders, substance abuse/addiction, dementia, PTSD, or another clinically relevant disorder.
3. Epilepsy.
4. Chronic debilitating disease, including significant cardiac, pulmonary, hepatic, or renal disease.
5. Known diagnosis of obstructive sleep apnea, REM sleep behavior disorder, or narcolepsy.
6. Regular circadian-rhythm disruption, including shift work or treatment interfering with circadian rhythm or sleep cycles, such as prazosin.
Source: ClinicalTrials.gov (NCT07891806). StuddyBuddy aggregates publicly available trial information.