Clinical Trials in Digital Medicine

mSToPS –

Using wearable sensors to detect asymptomatic atrial fibrillation

The mHealth Screening To Prevent Strokes trial is a home-based clinical research study that uses wearable sensor technology to identify people with asymptomatic atrial fibrillation (AFib). The primary objective of the trial is to determine whether screening select individuals in their homes using wearable medical devices can identify people with asymptomatic AFib more efficiently than routine care.

The study, launched in November 2015, is a novel multisectoral collaboration between Scripps Translational Science Institute (STSI), Aetna’s Innovation Labs and Healthagen Outcomes units, and Janssen Pharmaceuticals, Inc.

Study participants will undergo continuous single-lead electrocardiogram (ECG) monitoring using the ZIO® XT Patch wearable sensor, developed by iRhytm Technologies. Additionally, a subset of participants will be invited to participate in a substudy that monitors heart rate and rhythm characteristics through the Amiigo wristband monitor.

To learn more, read the news release or visit ClinicalTrials.gov.

DigMed2 –

Using wireless monitoring to understand the body’s response to meditation

The practice of meditation has been part of human society for at least 5,000 years. This long history of meditation practice has persisted with the belief in its beneficial effects on the mind and body. There is no doubt that there is a strong mind-heart connection, although it remains poorly understood, especially in a medical or biological sense.

Many of the body’s interactions are thought to be regulated by the autonomic nervous system, which evidence suggests can be influenced by meditation. Despite that, widespread acceptance of meditation as being important for improving wellness is hindered by the limited data available defining its benefits. We hope that with the Digital Medicine in Meditation research study we will help to scientifically illuminate some of the benefits of meditation. Scripps Translational Science Institute (STSI) is excited to collaborate with the Chopra Center on this project. With STSI’s experience and expertise in digital and personalized medicine we hope to offer advanced insight into the body’s response to meditation by wirelessly and unobtrusively monitoring heart and brain activity during meditation.

This study took place during the Seduction of Spirit retreat at the Chopra Center, November 3-9, 2013.

Wired for Health –

Wireless monitoring for disease wellness and prevention

The Scripps Wired for Health Study aims to evaluate the impact of using a smartphone enabled “Wireless Monitoring System” in conjunction with a disease wellness and prevention program on the healthcare costs and resource utilization of chronically ill individuals with diabetes, hypertension, and cardiac arrhythmia.

Consisting of a combination of current wireless medical devices designed for use in the management of these conditions, a smartphone, and an online software platform to analyze disease data and enable care coordination; our Wireless Monitoring System (wireless monitoring) will augment an existing outpatient Disease management program offered by Health Comp.

Comparative Effectiveness of Pocket Mobile Echocardiography vs. Transthoracic Echocardiography

A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).

The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.

GIRAFFE Study –

Genomic Risk Markers for Atrial Fibrillation Following Extended Cardiac Rhythm Monitoring

Multicenter (17 sites), nationwide study of an anticipated ~1500 individuals presenting with symptoms suggestive of, but not yet diagnosed as Afib. Receive a Zio patch for 2 weeks rhythm monitoring plus genetic testing to identify novel markers for Afib risk.

Scanadu SCOUT™ –

Scanadu Consumer Health Outcomes Study

Evaluate the real-world use of the Scanadu ScoutTM by a cohort of self-selected investors in an earlier crowdfunding campaign on Indiegogo for the Scanadu Scout™, through a prospective observational study. Using validated survey tools and through the remote tracking of frequency of use and physiological measurements from the Scanadu Scout™ device and app.

Participants will receive web-based surveys at 4 time points: baseline, 3, 12 and 18 months.

Wearable Sensors for Objective Measures of PTSD

A pilot study in collaboration with the Navy to intensively monitor sleep quality, activity and ANS function of 40 servicemen/women dx with PTSD who are already scheduled to take part in a 10 week residential treatment program using an innovative wristband sensor that continuously monitors measures of stress, activity and sleep quality. The hope is to acquire data that in the future will permit markedly improved diagnosis and treatment of PTSD sufferers.

Pilot Study of the MultiSense Patch in the Home Diagnosis of Sleep Apnea

To compare multiple biometric parameters tracked by the MultiSense™ to gold standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated sleep study will help us to make these determinations. Subjects will wear the device, which is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects will go about their normal daily activities and return the device via mail once completed.

Pilot Study of the Quanttus Device for Monitoring Patients with Heart Failure

The study proposes to utilize a novel, wearable device, Quanttus Device, developed by Quanttus, Inc which has multiple sensors embedded in a “wrist-watch” in order to explore its monitoring capabilities in individuals with congestive heart failure.

Self-Directed Biological Transformation Initiative – SBTI

This is a follow-up study of the DigMed2 study in collaboration with the Chopra Center, as well as UCSD, UCSF, Harvard and Mt.Sinai Hospital of New York. Individuals attending a “Perfect Health” retreat will undergo extensive testing and monitoring before and after the retreat in order to identify novel biomarkers of stress and its improvement. For the mobile health arm of the study individuals will wear a MultiSense wireless patch for one week before and one month after the retreat.

For further information regarding any of the studies listed, please contact us at [email protected]