Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT04780893
Status:
WITHDRAWN
Last Update Posted:
2024-01-16
First Post:
2020-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrical Vestibular Nerve Stimulation (VeNS) as a Method of Sleep Management in People With PTSD
Sponsor:
Neurovalens Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double Blind Sham Controlled, Pilot Study to Evaluate the Efficacy of Vestibular Nerve Stimulation (VeNS) for Sleep Management in People With Post- Traumatic Stress Disorder (PTSD).
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New trial opportunity in the USA.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This double blind randomized controlled study will enroll 20 subjects and will be conducted remotely. The study will be randomized for an 8-week period with a 1:1 active to sham device allocation. Primary endpoint analysis will be performed at 4 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: