Summary
Embrace Plus is a smartwatch with a broad range of medical-grade sensors that continuously monitors and records physiologic parameters, which are sent via Bluetooth to a dedicated mobile app (Care App), which then transfers all data to the Empatica cloud and then onto the Care Portal for review of data and digital biomarkers. The Embrace Plus has five sensors including PPG, electrodermal activity (EDA), Skin Thermometer, Accelerometer, and Gyroscope. There are several preconfigured modes, including Pulse Rate Pro, SpO2 Pro, and Actigraphy Pro, actigraphy digital biomarkers, raw accelerometry data, plus wearing detection, EDA, temperature, event markers, a hypoallergenic waterproof band, and automated continuous data transfer. There are 7 and 14 day battery options (see technical). Empatica Health Monitoring Platform, EmbracePlus watch, Empatica Care, and the Care Portal are FDA cleared (10/30/23) for retrospective review of continuous HR, SpO2 and RR (both under no motion conditions), skin temperature, electrodermal activity, and activity during sleep. It can used to analyze circadian rhyhtms but is not intended for apnea or dysrhythmia diagnosis. The dashboard allows a quick look at step counts, sleep, and other data.
Claimed Capabilities/Measurements
EmbracePlus is a medical-grade smartwatch intended for continuous health monitoring for both clinical and research uses. With a broad range of medical grade sensors, the Empatica Embrace Plus is capable of continuous physiologic data collection, access to high-quality raw data, and an extensive range of digital biomarkers and analytics. The website claims that EmbracePlus is one of the few wearables with no black box algorithms that capture high-quality, high-frequency, and continuous raw data. It claims to offer the most complete set of activity and sleep measures including raw 3-axis accelerometer data, gait speed and advanced gait analysis, stride velocity, step counts, wearing detection, sleep analusis, sleep detection, 6MWT, activity classification/ intensity/ counts, energy expenditure, MWPA, and body position. It has event marking, automated and continuous data transfer, long battery life (see technical), and can be worn on the wrist, belt, and ankle.
Mechanism
SpO2, HR, RR, temperature, motion, position.
Sensors
Ventral electrodermal activity (EDA) sensor, optical PPG, digital skin temperature, accelerometer, and gyroscope
Technical Considerations
Actigraphy Pro: 7 day battery life, 64 Hz sampling; Actigraphy optimized: 14 day battery, 32 Hz sampling rate
Publications and Related Abstracts
Citation: Gerboni G, Comunale G, Chen W, Lever Taylor J, Migliorini M, Picard R, Cruz M, Regalia G. Prospective clinical validation of the Empatica EmbracePlus wristband as a reflective pulse oximeter. Front Digit Health. 2023 Dec 4;5:1258915.
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Industry Support: Yes
Validation Study: Yes
Comparison Test(s): Blood samples analyzed by a co-oximeter
Study Summary: Three hundred seventy-three measurements were done on 15 subjects, including 30% with dark skin pigmentation using a controlled hypoxic protocol (SpO2 70-100%; Clinical trial NCT04964609). The accuracy root mean square error was 2.4%. There was a strong correlation between watch SpO2 and reference SpO2 (0.96; p<0.001) and acceptable accuracy stratifying by skin pigmentation and gender. The authors concluded it has good accuracy under no motion and high perfusion conditions in different ethnicities.
Citation: Grasser LR, Erjo T, Goodwin MS, Naim R, German RE, White J, Cullins L, Tseng WL, Stoddard J, Brotman MA. Can peripheral psychophysiological markers predict response to exposure-based cognitive behavioral therapy in youth with severely impairing irritability? A study protocol. BMC Psychiatry. 2023 Dec 11;23(1):926.
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Industry Support: Yes
Validation Study: No
Comparison Test(s): N/A
Study Summary: This is a feasibility study to evaluate if biosensing data can provide physiologic indicators to session exposures. The study describes the protocol to collect blood volume pulse (BVP; used to derive HR and HRV) and ectodermal activity (EDA) using the Empatica EmbracePlus from 40 youth (all genders; ages 8-17) undergoing six in-person exposure treatment sessions, as part of a multiple-baseline trial of exposure-based CBT for clinically impairing irritability. Clinical trial NCT02531893.
Citation: Stuyck H, Dalla Costa L, Cleeremans A, Van den Bussche E. Validity of the Empatica E4 wristband to estimate resting-state heart rate variability in a lab-based context. Int J Psychophysiol. 2022 Dec;182:105-118.
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Industry Support: No
Validation Study: Yes
Comparison Test(s): ECG
Study Summary: HR and HRV by Empatica E4 wristband was compared to ECG in 79 undergraduate students in Belgium. HR was validly estimated by the E4 with intervals as short as 10 s. Root mean square of successive differences between normal IBIs (RMSSD) and standard devision of normal interbeat interval required 30 s, 120 s or an average over multiple 10 s intervals. The authors concluded that E4 Empatica wristband can be a valuable tool in lab research to estimate HR and HRV.
Clinical Trials
Related Technologies
Fitbit watches; Fitbit trackers, Actigraph LEAP, Centrepoint watch, Fibions, Motionwatch 8, Vyvo biosense ring, motionlogger watch, Activinsights, CamNTech motionwatch, Whooop 4.0
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