Sleep Modulation to Treat Depression

Last updated: July 22, 2024
Sponsor: Christoph Nissen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression (Major/severe)

Depression

Depression (Adult And Geriatric)

Treatment

Auditory closed-loop stimulation

Sham stimulation

Clinical Study ID

NCT06443216
2023-01804
  • Ages 30-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent

  • MDD according to ICD-10 criteria (F32.1/2, F33.1/2; i.e. unipolar depression) forpatient group

Exclusion

Exclusion Criteria:

  • Relevant psychiatric disorders (other than MDD for the patient group), such asorganic psychiatric disorders, lifetime history of substance dependency or currentsubstance abuse (smoking will be allowed for recruitment reasons), schizophrenia orother 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 limbmovement 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 thanantidepressants and lithium in patients); patients receiving benzodiazepines or (es)ketamine will not be included

  • Current brain stimulation treatment, such as electroconvulsive therapy (ECT), TMS ordeep brain stimulation

  • Contraindications for tDCS or TMS studies, including but not limited to metal in thehead/ brain or epilepsy

  • Hearing impairment or tinnitus (auditory stimulation study)

  • Inability to follow the procedures of the study (for example due to languageproblems)

  • Left-handedness

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Auditory closed-loop stimulation
Phase:
Study Start date:
July 22, 2024
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • University of Geneva

    Geneva,
    Switzerland

    Active - Recruiting

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