Sleep Modulation as Antidepressant Randomized Trial

NCT ID: NCT05685771

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-07-25

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.

Conditions

Depression; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Auditory stimulation first

This study group receives auditory stimulation in the first intervention week (second week of trial) and sham stimulation in the second intervention week (fourth week of trial).

Group Type: OTHER

Phase-targeted auditory stimulation

Intervention Type: DEVICE

Bursts of pink noise (50 ms) played during deep non-REM sleep at specific phases of sleep slow waves.

Sham stimulation first

This study group receives sham stimulation in the first intervention week (second week of trial) and auditory stimulation in the second intervention week (fourth week of trial).

Group Type: OTHER

Phase-targeted auditory stimulation

Intervention Type: DEVICE

Bursts of pink noise (50 ms) played during deep non-REM sleep at specific phases of sleep slow waves.

Interventions

Phase-targeted auditory stimulation

Bursts of pink noise (50 ms) played during deep non-REM sleep at specific phases of sleep slow waves.

Intervention Type: DEVICE

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
• Inability 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 application
• Conditions 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 night
• Low 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 sleep
• Participation in another clinical trial during the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ETH Zurich

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

Psychiatric University Hospital, Zurich

OTHER

Sponsor Role: collaborator

Giulia Da Poian

OTHER

Sponsor Role: lead

Responsible Party

Giulia Da Poian

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Giulia Da Poian, PhD

Role: PRINCIPAL_INVESTIGATOR

Sensory-Motor Systems Lab, IRIS, ETH Zurich

Locations

Sensory-Motor Systems Lab

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2022-D0092

Identifier Type: -

Identifier Source: org_study_id