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NCT Number: NCT06443216

Sleep Modulation to Treat Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Healthy Mental Disorders Mood Disorders

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Geneva

Geneva, Switzerland

Location status: Recruiting

Location contact

Christoph Nissen, Prof. Dr. med.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory closed-loop stimulation

Device

Auditory closed-loop suppression of slow wave sleep

Sham stimulation

Device

No auditory stimulation

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Nissen, Prof. Dr. med.

CONTACT

[email protected]

+41.22.305.45.38

Sponsors and collaborators

Lead sponsor

Christoph Nissen

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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