Assessing the Symptomatic Benefit of Slow-wave Activity Reduction Using Wearables and Sensor-based Characterization of Depression: a Randomized, Counter-balanced Crossover Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Giulia Da Poian
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Depression severity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Giulia Da Poian
Principle Investigator
ETH Zurich
Eligibility Criteria
Inclusion Criteria
- •Male and female adults aged 18-55 years
- •Motivated, no aversion against technology
- •Able to give informed consent as documented by signature, and to follow the technical instructions
- •Able to understand and speak German or English as required for the interview (HDRS) and to answer the questionnaires
- •Diagnosis 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 period
- •Bipolar disorder or psychotic symptoms in the history
- •Relevant disease or medication that could present a risk for the participant or that could influence study findings
- •Known sleep apnea (diagnosed or ESS ≥10 points) or periodic limb movement syndrome
- •Known alcoholism or drug abuse
- •Diagnosed hearing impairment/presbycusis
- •Irregular 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/operations
- •Known epilepsy or for any reason, intracranial space-occupying lesions or (infectious or autoimmune) inflammatory diseases of the central nervous system
- •Shift workers
Outcomes
Primary Outcomes
Depression severity
Time Frame: baseline; after first intervention week; after second intervention week
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.
Secondary Outcomes
- Subjective momentary sleepiness(first intervention week; second intervention week)
- Response rate(after first intervention week; after second intervention week)
- MR Spectroscopy(after first intervention week; after second intervention week)
- Electroencephalographic (EEG) topography(last night of first intervention week; last night of second intervention week)
- Brain connectivity(after first intervention week; after second intervention week)