Development of medical device software for the screening and assessment of depression severity using data collected from a wristband-type wearable device: SWIFT study protocol.

Few biomarkers can be used clinically to diagnose and assess the severity of depression. However, a decrease in activity and sleep efficiency can be observed in depressed patients, and recent technological developments have made it possible to measure these changes. In addition, physiological changes, such as heart rate variability, can be used to distinguish depressed patients from normal persons; these parameters can be used to improve diagnostic accuracy. The proposed research will explore and construct machine learning models capable of detecting depressive episodes and assessing their severity using data collected from wristband-type wearable devices. Patients with depressive symptoms and healthy subjects will wear a wristband-type wearable device for 7 days; data on triaxial acceleration, pulse rate, skin temperature, and ultraviolet light will be collected. On the seventh day of wearing, the severity of depressive episodes will be assessed using Structured Clinical Interview for DSM-5 (SCID-5), Hamilton Depression Rating Scale (HAMD), and other scales. Data for up to five 7-day periods of device wearing will be collected from each subject. Using wearable device data associated with clinical symptoms as supervisory data, we will explore and build a machine learning model capable of identifying the presence or absence of depressive episodes and predicting the HAMD scores for an unknown data set. Our machine learning model could improve the clinical diagnosis and management of depression through the use of a wearable medical device. [https://jrct.niph.go.jp/latest-detail/jRCT1031210478], identifier [jRCT1031210478].

Informations de copyright

Copyright © 2022 Kishimoto, Kinoshita, Kikuchi, Bun, Kitazawa, Horigome, Tazawa, Takamiya, Hirano, Mimura, Liang, Koga, Ochiai, Ito, Miyamae, Tsujimoto, Sakuma, Kida, Miura, Kawade, Goto and Yoshino.

Déclaration de conflit d'intérêts

TaK was the president of i2medical LLC and has received consultant fees from Otsuka, Pfizer, and Sumitomo and speaking fee from Banyu, Eli Lilly, Sumitomo, Janssen, Novartis, Otsuka, and Pfizer. TH was a board member of i2medical LLC and had received consulting fees from FRONTEO Inc. YTa, K-cL, and NK were a board member of i2medical LLC. YO, HI, YM, and YTs were employed by Sumitomo Pharma Co., Ltd. GM has received speaking fees from Janssen, Meiji Seika Pharma, Otsuka, and Yoshitomi Yakuhin. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.