Pilot evaluation and validation study of SmartCardia SA SmartWearable against PSG measurements: home based clinical trials of sleep apnea/hypopnea syndrome patients and healthy control subjects

01/10/17 to 31/03/19

The ANAPNEO project is directly funded by Smartcardia, which is a Swiss medical device company with focus on clinical quality data and validation (http://www.smartcardia.com/). Its aim is to scientifically evaluate and validate a smart, wearable device used to extract multi-faceted daily and sleep data for precision sleep medicine and prevention of sleep disorders. The project started at October of 2017 and is expected to terminate at March of 2019. The project activities include the recruitment of the following groups: a) healthy volunteers, b) patients suffering from sleep disorders such as insomnia and hyperarousal, c) patients suffering from sleep-related breathing disorders (apneas/hypopneas). Each group consists of 10 participants. Each participant is examined in two experimental phases. Each experimental face lasts 72 successive hours and includes unobtrusive monitoring of sensorial information for extracting activity and lifestyle patterns through the smartcardia sensor. These multi-faceted daily and sleep data are fused with polysomnographic data acquisition obtained during the second experimental night in order to provide reliable markers of sleep quality. The interval among the two experimental phases is 2-3 months in order to check for seasonal effects, nutrition or lifestyle alterations. 

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