Pulse Rate/SPO2/Respiration Rate/RR-intervals/Blood Pressure/Device Position Test for Corsano CARDIOWATCH 287-2 during High Intensity Interval Training: an Evaluation Study (HIIT-OXI-NIBP-POS)

In today's world, continuous monitoring of vital signs remains a challenge, as
it generally requires patients to be connected to multiple wired sensors, which
limits their mobility. Wearable wrist devices, although gaining popularity, are
often not clinically validated or limited to monitoring one or two vital signs.
The CardioWatch Bracelet is a remote monitoring system designed to continuously
collect data in healthcare and home environments. CardioWatch 287-2 is a
CE-certified medical device under EU-MDR conditions. It is capable of
monitoring heart rate, heart rate variability (RR intervals), ECG, SpO2,
respiration, body temperature, blood pressure, activity, and sleep.

This study aims to evaluate the Corsano Cardiowatch 287-2 for heart rate, heart
rate variability (RR intervals), oxygen saturation, respiratory rate, and blood
pressure during strenuous activities such as High-Intensity Interval Training
(HIIT). Validation will be conducted for heart rate values with a root mean
squared error (RMSE) of <= 4, respiratory rate with a RMSE of <= 2 breaths per
minute (brpm), peripheral oxygen saturation with a RMSE of <= 3 percentage
points, and blood pressure according to ISO 81060-2:2018 with a RMSE of <= 5
mmHg.

This study involves adult volunteers who have provided informed consent to
participate in the research. Participants are asked to perform a High-Intensity
Interval Training on a stationary bike (LifeSpan R3i), during which heart rate,
heart rate variability, blood pressure, SpO2, and respiratory rate are
measured. This is done using both CE-marked devices considered as the gold
standard (Covidien Nellcor PM10N pulse oximeter, Bosh+Sohn Boso APBM blood
pressure monitor, Vivalink ECG patch) and the CE-marked Corsano CardioWatch
287-2. Two initialization measurements are taken before the workout, with one
measurement using the Corsano CardioWatch 287-2 at a 90-degree angle.
Participation in the study takes approximately 20 minutes, and participants
will not experience any inconvenience. The data is collected in Corsano's
certified cloud, and the results will be compared afterward. The data is fully
pseudonymized.

Participants will be asked for informed consent. If consent is granted, the
participant will be connected to the Corsano Cardiowatch 287-2, Covidien
Nellcor PM10N pulse oximeter, Bosh+Sohn Boso APBM blood pressure monitor, and
Vivalink ECG patch during a High-Intensity Interval Training (HIIT) on a
stationary bike for continuous monitoring and reference measurements. Once the
procedure is completed, the Corsano Cardiowatch 287-2 and all other devices
will be removed. There will be no follow-up.
The risks associated with this study are very low, given the non-intrusiveness
of the research device and the conventional sensors of the reference devices.
The Vivalink ECG patch may cause minor skin irritation.
Participants in the study will not receive any direct benefits from
participating in the research.