Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753385
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2021-01-07
Brief Title:
The RECOVER sUb-study Which Leverages quaNtitative and Credible Research tOols From Verily Will providE Assessment measuRes for Depressive Episodes
Sponsor:
LivaNova
Organization:
LivaNova
Study Overview
Official Title:
The RECOVER sUb-study Which Leverages quaNtitative and Credible Research tOols From Verily Will providE Assessment measuRes for Depressive Episodes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
UNCOVER
Brief Summary:
The objective of this study is to collect both active and passive data using a wearable multi-sensor device Verily Study Watch and phone application Mood App which aims to capture mental health status in subjects participating in the RECOVER clinical trial A Prospective Multi-center Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Detailed Description:
A prospective observational exploratory study collecting passive and active behavioral environmental and physiological data via the use of an Android smartphone application and Study Watch
This sub-study is only open to sites participating in the RECOVER clinical study
All subjects participating in the RECOVER clinical trial that currently own an Android smartphone will be offered participation in this sub-study
Subjects who opt-in to the Mood App portion of the sub-study will be followed for a minimum of 12 months and a maximum of 60 months for the Mood App portion of the sub-study
Subjects who also opt-in to the use of the Study Watch portion of the sub-study will be followed for a minimum of 12 months and maximum of 24 months for the Study Watch portion of the sub-study
This sub-study is only open to sites participating in the RECOVER clinical study
All subjects participating in the RECOVER clinical trial that currently own an Android smartphone will be offered participation in this sub-study
Subjects who opt-in to the Mood App portion of the sub-study will be followed for a minimum of 12 months and a maximum of 60 months for the Mood App portion of the sub-study
Subjects who also opt-in to the use of the Study Watch portion of the sub-study will be followed for a minimum of 12 months and maximum of 24 months for the Study Watch portion of the sub-study
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