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.
This study consists of two parts: CLINICAL TRIAL PART: This part will be conducted in depressed and age- and sex-matched healthy participants. It has a double-blind, randomized crossover design. Each participant will undergo 1 week of baseline monitoring, followed by 1 week of in-home stimulation and 1 week of placebo condition interleaved with 1 week wash-out period. The last night of each intervention week will take place in a laboratory setting. A final week of follow-up will follow the second intervention week. The following data is collected: * Single-channel EEG (at home) and high-density electroencephalogram (hdEEG) (in laboratory) * MR imaging * Daily questionnaires * Passive behavioural and physiological measurements MONITORING PART: This observational study part will be conducted in depressed participants only. Each participant will undergo 5 weeks of remote monitoring using wearable devices and smartphones. Patients not eligible for the CLINICAL TRIAL PART, or that meet an exclusion criterion at any point in the study, can be assigned to this study part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
70
Bursts of pink noise (50 ms) played during deep non-REM sleep at specific phases of sleep slow waves.
Sensory-Motor Systems Lab
Zurich, Switzerland
Depression severity
Change in Hamilton Depression Rating Score (HDRS) as compared to baseline score. The 17-item HDRS is on a scale of 0-52 with higher scores indicating more severe symptomatology.
Time frame: baseline; after first intervention week; after second intervention week
Response rate
Change in response rate in the Hamilton Depression Rating Score. Response is defined as a reduction of at least 50% compared to baseline or score \<8 points.
Time frame: after first intervention week; after second intervention week
Subjective momentary sleepiness
Compare momentary sleepiness using the Karolinska Sleepiness Scale (KSS) between the two intervention weeks. KSS scores range from 1-10 with higher scores indicating higher sleepiness.
Time frame: first intervention week; second intervention week
Electroencephalographic (EEG) topography
Change in topography of the electric brain activity (EEG) during sham and stimulation night in the laboratory. Spectral decomposition of the signal will be performed to compare single frequency bins and established frequency bands (delta, theta, alpha, sigma, beta, gamma).
Time frame: last night of first intervention week; last night of second intervention week
MR Spectroscopy
Changes in Glutamate/Glutamine (combined as Glx) in the dorsolateral prefrontal cortex as assessed by magnetic resonance spectroscopy between sham and stimulation weeks.
Time frame: after first intervention week; after second intervention week
Brain connectivity
Change in resting state functional connectivity (fMRI) between sham and stimulation weeks.
Time frame: after first intervention week; after second intervention week
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