Sleep Modulation as Antidepressant Randomized Trial

NCT05685771 | Completed

• 1 other identifier: 2022-D0092
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Healthy

Keywords

Healthy; Depression; Auditory stimulation; Sleep

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline; after first intervention week; after second intervention week

Secondary Outcomes (5)

• Response rate

  after first intervention week; after second intervention week

• Subjective momentary sleepiness

  first intervention week; second intervention week

• Electroencephalographic (EEG) topography

  last night of first intervention week; last night of second intervention week

• MR Spectroscopy

  after first intervention week; after second intervention week

• Brain connectivity

  after first intervention week; after second intervention week

Study Arms (2)

Auditory stimulation first

OTHER

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).

Device: Phase-targeted auditory stimulation

Sham stimulation first

OTHER

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).

Device: Phase-targeted auditory stimulation

Interventions

Phase-targeted auditory stimulation DEVICE

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

Auditory stimulation first; Sham stimulation first

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Giulia Da Poian: lead
• ETH Zurich: collaborator
• University of Zurich: collaborator
• Psychiatric University Hospital, Zurich: collaborator

Study Sites (1)

Sensory-Motor Systems Lab

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Giulia Da Poian, PhD

  Sensory-Motor Systems Lab, IRIS, ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 17, 2023
• Study Start: April 1, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests can be submitted starting after article publication
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA)

Locations

CH (1)