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.
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 wearable device with multiple sensors that can continuously track a spectrum of physiological data and, through the Empatica Health Monitoring platform, can offer researchers 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.
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.