We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes (UNCOVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04753385
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
LivaNova

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).

Condition or disease
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentage of PHQ-8 tasks [ Time Frame: Through study completion; Average 2 years ]
    Percentage of PHQ-8 tasks completed over the duration of the study

  2. Percentage of Voice Diary tasks [ Time Frame: Through study completion; Average 2 years ]
    Percentage of Voice Diary tasks completed over the duration of the study

  3. Number of ping sensor recordings [ Time Frame: Through study completion; Average 2 years ]
    Number of ping sensor recordings over the duration of the study

  4. Number of hours of watch wear time [ Time Frame: Through study completion; Average 2 years ]
    Number of hours of watch wear time over the duration of the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This sub-study is only open to sites participating in the RECOVER clinical study.

Every subject that currently owns an Android smartphone will be offered to opt-in to the sub-study.

Criteria

Inclusion Criteria:

All Subjects

  1. Current consented subject in the RECOVER clinical trial;
  2. Adult (i.e. ≥ 18 years of age, unless a resident of any U.S. state where the age of majority is 19, in which case must be ≥ 19 years of age);
  3. Able and willing to provide written informed consent for this sub-study;
  4. Able and willing to comply with all study procedures;
  5. Able to read and speak English.

Phone Application

  1. Have a personal Google user account or be willing to create and own a personal Google user account;
  2. Owns a personal Android smartphone with a data plan and is the sole user of that smartphone;
  3. Agrees to download and maintain the phone application onto personal Android smartphone for the duration of the sub-study;

Study Watch

1. Willing to comply with Study Watch wearing and recharging requirements

Exclusion Criteria:

All Subjects

1. Any condition or situation the Principal Investigator determines as inappropriate for study inclusion

Phone Application

No additional exclusion criteria for phone application

Study Watch

1. Subjects with known severe allergy to nickel or metal jewelry


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753385


Contacts
Layout table for location contacts
Contact: Shannon L Majewski (817) 771-9195 shannon.majewski@livanova.com
Contact: Jeff Way (281) 228-7394 jeffrey.way@livanova.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
LivaNova
Investigators
Layout table for investigator information
Principal Investigator: Charles Conway, MD Washington University School of Medicine
Layout table for additonal information
Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT04753385    
Other Study ID Numbers: LND300
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LivaNova:
Depression
TRD
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders