NCT06443216

Sleep Modulation to Treat Depression

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Christoph Nissen · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Major Depressive Disorder
• Healthy

Interventions

Type	Name	Description
DEVICE	Auditory closed-loop stimulation	Auditory closed-loop suppression of slow wave sleep
DEVICE	Sham stimulation	No auditory stimulation

Timeline

• Start date: 2024-07-22
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-06-05
• Last updated: 2024-07-23

Locations

1 site across 1 country: Switzerland