Sleep Modulation as Antidepressant Randomized Trial

The goal of this clinical trial is to learn about the effects of phase-targeted auditory stimulation in depressed patients and healthy controls.The main questions it aims to answer are:Is auditory down-phase stimulation efficient in improving depression symptoms as compared to sham stimulation?Can mood and other outcomes be prospectively estimated by multi-parametric passive data?Participants will perform auditory stimulation using a wearable device at home and provide data on their phone usage and activity.Researchers will compare depressed patients and healthy participants to see if auditory down-phase stimulation effects them differently.

Inclusion Criteria:Male and female adults aged 18-55 yearsMotivated, no aversion against technologyAble to give informed consent as documented by signature, and to follow the technical instructionsAble to understand and speak German or English as required for the interview (HDRS) and to answer the questionnairesDiagnosis of depression according to DSM-5 criteria (depressed) OR no diagnosis of depression AND no depressive episode in the history (healthy)≥17 points in Hamilton Depression Rating Score (HDRS, corresponding to at least moderate-mild depression, depressed) OR <8 points in HDRS (healthy)Stable or no pharmacological antidepressant therapy, no acute suicidal tendency (depressed)Exclusion Criteria:Pregnant or lactating women, women planning to get pregnant during the study periodBipolar disorder or psychotic symptoms in the historyRelevant disease or medication that could present a risk for the participant or that could influence study findingsKnown sleep apnea (diagnosed or ESS ≥10 points) or periodic limb movement syndromeKnown alcoholism or drug abuseDiagnosed hearing impairment/presbycusisIrregular intake of centrally depressing or stimulating medication known to alter sleep EEG (e.g., benzodiazepines)History of traumatic brain injury (except for concussion) or neurosurgical procedures/operationsKnown epilepsy or for any reason, intracranial space-occupying lesions or (infectious or autoimmune) inflammatory diseases of the central nervous systemShift workersInability to follow the procedures of the study, e.g., due to language problems, dementia, etc.Skin diseases/skin problems (in the face/ear/chest area) or allergies that could be aggravated by electrode applicationConditions that may interfere with the MRI (e.g., MR unsafe cardiac pacemaker or a defibrillator, MR unsafe metal in or near the head, spinal cord, eyes, or in the chest)Indications of sleep apnea (Apnea Hypopnea Index >15/h) or periodic limb movement syndrome (PLMS index >15/h) in the screening nightLow stimulation efficiency (<500 stimulations detected by the device) in the screening night or in 3 subsequent home recording nights, e.g., due to very little deep sleepParticipation in another clinical trial during the study period