Using sleep modulation to treat depression
Auditory Closed-loop Modulation of Slow Wave Sleep to Treat Major Depressive Disorder
This study is testing a new sleep treatment to see if it can help people with major depression feel better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT06443216 on ClinicalTrials.gov |
What this trial studies
This study aims to explore a novel approach to treating major depressive disorder by utilizing sleep neurophysiology. It involves a single-center, double-blind, randomized, sham-controlled design where participants will undergo auditory closed-loop stimulation during sleep across four nights in a sleep laboratory. The primary goal is to determine if this sleep-based treatment can significantly reduce depressive symptoms compared to a sham stimulation. Both patients with major depression and healthy controls will be included to assess the treatment's feasibility and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with major depressive disorder according to ICD-10 criteria.
Not a fit: Patients with other psychiatric disorders, unstable medical conditions, or significant sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective treatment option for patients suffering from major depressive disorder.
How similar studies have performed: While the use of sleep modulation in treating depression is an emerging field, similar studies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Geneva
- University of Geneva — Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Christoph Nissen, Prof. Dr. med.
- Email: christoph.nissen@hug.ch
- Phone: +41.22.305.45.38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.