Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443216
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-22
Brief Title:
Sleep Modulation to Treat Depression
Sponsor:
Christoph Nissen
Organization:
University of Geneva Switzerland
Study Overview
Official Title:
Auditory Closed-loop Modulation of Slow Wave Sleep to Treat Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None