Phase 2 trial will explore safety and efficacy of new treatments for PTSD and utility of digital measures to identify PTSD subtypes and personalize care for active-duty service members and veterans
BOSTON–(BUSINESS WIRE)–Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced that they have been chosen by the United States Department of Defense (DoD) Defense Health Agency’s Posttraumatic Stress Disorder Drug Treatment Program as a technology partner for a clinical study aimed at developing new therapies to treat PTSD.
The Phase 2, randomized, double-blinded, placebo-controlled study will evaluate multiple potential pharmacotherapeutic interventions for PTSD in active-duty service members and veterans. PTSD is a mental health condition that is triggered by a traumatic event that happens to or is witnessed by an individual. Worldwide, approximately 4% of all people will experience PTSD, and according to the United States Department of Veterans Affairs, approximately 7% of all veterans will develop PTSD at some point in their lives, with those who have been deployed three times likelier to develop the condition. Symptoms may include flashbacks, nightmares, severe anxiety and uncontrolled thoughts about the event.
“We are honored to be the DoD’s choice as a technology partner for this important study. The challenges posed by PTSD are substantial, both for those who serve and for all who face traumatic life events. Growing our understanding of this condition is critical in addressing the growing mental health epidemic,” said Matteo Lai, CEO and Co-Founder of Empatica. “We are confident that the data generated by our platform will play a key role in advancing the mental health care provided to veterans and active-duty personnel, as well as to all who may suffer from PTSD.”
This study, led by the U.S. Army Medical Materiel Development Activity (USAMMDA), will examine the efficacy and safety of treatments, including those currently approved by the FDA for insomnia and depression, when used for PTSD. Participants will wear Empatica’s FDA-cleared EmbracePlus smartwatch, a powerful wearable device with multiple sensors that can continuously track a broad spectrum of physiological data and, through the Empatica Health Monitoring platform, can offer researchers unparalleled access to raw sensor data and over 100 digital measures. Researchers will use EmbracePlus to look at sleep, actigraphy and electrodermal activity (EDA) data from trial participants.
People living with PTSD are at a higher risk for sleep challenges, neurocognitive problems, substance abuse, suicide and more. Using EmbracePlus data, the researchers hope to explore the utility of digital measures to diagnose and predict PTSD subtypes, as well as monitor the effect of individual interventions on PTSD symptoms and groups of symptoms, which can unlock opportunities for personalized care, lowering the prevalence and impact of the condition.
Complete trial details are available here: https://www.clinicaltrials.gov/ct2/show/NCT05422612. Effort sponsored by the Government under Other Transactions Number W81XWH-15-9-0001; the U.S. Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding any copyright notation thereon. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.
To learn more about EmbracePlus and the Empatica Health Monitoring Platform, please visit us at https://www.empatica.com/.
Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica’s FDA-cleared platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. Its flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and the NASA-funded TRISH.
The U.S. Army Medical Materiel Development Activity, part of the U.S. Army Medical Research and Development Command, is the DoD’s premier developer of world-class military medical capabilities. USAMMDA develops, delivers, and fields critical drugs, vaccines, biologics, devices, and medical support equipment to protect and preserve the lives of Warfighters across the globe.