Sleep Modulation to Treat Depression

July 22, 2024 updated by: Christoph Nissen

Auditory Closed-loop Modulation of Slow Wave Sleep to Treat Major Depressive Disorder

Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The planned study is a single-centre, doubled-blind, randomized, sham controlled, repeated measures within-subject (stimulation and sham) study including patients with major depression and healthy controls, across four sleep laboratory nights (adaptation, baseline, stimulation and sham in counterbalanced order). The investigators will test the primary hypothesis that auditory-closed loop suppression of slow wave sleep will improve depressive clinical symptomatology compared to sham stimulation.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Recruiting
        • University of Geneva
        • Contact:
          • Christoph Nissen, Prof. Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Written informed consent
  • MDD according to ICD-10 criteria (F32.1/2, F33.1/2; i.e. unipolar depression) for patient group

Exclusion Criteria:

  • Relevant psychiatric disorders (other than MDD for the patient group), such as organic psychiatric disorders, lifetime history of substance dependency or current substance abuse (smoking will be allowed for recruitment reasons), schizophrenia or other psychotic disorders, affective disorders including bipolar disorder, borderline personality disorder, autism or other severe psychiatric disorders
  • Known pregnancy
  • Unstable medical conditions, such as unstable cardiovascular or metabolic disorders, etc.
  • Relevant neurological disorders, including epilepsy, stroke, etc.
  • Organic sleep disorders including relevant sleep apnea (AHI>15/h), periodic limb movement disorder (PLMS index>5/h), Restless-Legs-Syndrome (RLS), narcolepsy, circadian rhythm disorder or shift work/ jet lag
  • Intake of medication affecting the central nervous system (other than antidepressants and lithium in patients); patients receiving benzodiazepines or (es)ketamine will not be included
  • Current brain stimulation treatment, such as electroconvulsive therapy (ECT), TMS or deep brain stimulation
  • Contraindications for tDCS or TMS studies, including but not limited to metal in the head/ brain or epilepsy
  • Hearing impairment or tinnitus (auditory stimulation study)
  • Inability to follow the procedures of the study (for example due to language problems)
  • Left-handedness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Patients with major depressive disorder according to ICD-10 criteria
Device: Auditory closed-loop stimulation
Auditory closed-loop suppression of slow wave sleep
Device: Sham stimulation
No auditory stimulation
Experimental: Healthy Group
Healthy controls
Device: Auditory closed-loop stimulation
Auditory closed-loop suppression of slow wave sleep
Device: Sham stimulation
No auditory stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Åsberg Depression Rating Scale
Time Frame: Up to three weeks

Measure of the severity of depressive symptomatology

The scores range between 0 to 60. The higher the score, the more symptamology of depression the subjects presents.
Up to three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christoph Nissen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01804

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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