Heart rate variability (HRV) was measured using a T-shirt wearable device attached to a transmitter in front of the T-shirt. The HRV data were transferred and recorded on a smartphone using Bluetooth. At the same time, life events, such as abdominal symptoms, defecation, eating, and awakening or sleep, were recorded in real time using a smartphone application software during HRV recording.
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Our study has two critical strengths. First, we could perform real-time recording of life events and ANS activities using a wearable device and newly developed smartphone application software. Previous studies have only evaluated ANS activity during visceral pain perception by increasing colonic pressure using balloon inflation or sigmoidoscopy. The limitation of previous methods is that they are artificial conditions and could not evaluate ANS activity under physiological conditions of natural defecation with abdominal pain. As a strength of our study, we could evaluate ANS activity under natural conditions by simultaneously measuring HRV, life events, and symptoms. Real-time recording enables an accurate evaluation of the association between them. Second, as HRV was measured with a T-shirt-type wearable device, subjects felt less uncomfortable during the measurement. In most previous studies evaluating the ANS in patients with IBS, an ECG and a device that attaches a cord to the chest were used, which were considered to increase stress. Compared to healthy subjects, patients with IBS show exacerbated symptoms [33] and an increased stress response [34] due to added stress; therefore, it is important to reduce discomfort during measurement to accurately evaluate the ANS.
We thank Mizuho Nakao, Makoto Harada, Katsumi Takai, Koji Kotani (NTT DATA KANSAI Corporation), Yoshiaki Seko, Takao Nakano, Masahiro Takeda, Tetsuya Ogihara, Masayoshi Sasano, Hideyuki Numata, and Yoshifumi Semoto (NTT DATA MSE Corporation) for providing technical support in the development of the smartphone application software and software for the RR interval power spectral analysis.
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Note: Some benefit plans may exclude coverage of consumer wearable or personal mobile devices (such as a smart phone, smart watch, or other personal tracking devices), including any software or applications. DTC applications are generally excluded from benefit plan coverage.
These types of software are addressed by this document when they operate on a mobile device, have received FDA clearance or approval, are clinician-prescribed, and when the intent of the MSA is to evaluate, diagnose or treat an illness, injury, disease or its symptoms.
Korot and colleagues (2021) studied the Home Vision Monitor in a cohort study of 417 individuals to evaluate uptake and engagement of the application but no published studies have evaluated clinically meaningful outcomes related to use of the software.
Insulia was evaluated in a 13-month RCT which enrolled a total of 191 participants with inadequately controlled type 2 diabetes who were randomized into three groups: group 1 (standard care, n=63), group 2 (interactive voice response system, n=64) and group 3 (Diabeo-BI app software, n=64). At 4 months follow-up, HbA1c reduction was significantly higher in the telemonitoring groups (p
reSET and reSET-O are mobile device software applications intended to increase retention of individuals with opioid use disorder (OUD) and substance use disorder in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment, for individuals 18 years or older who are currently under the supervision of a clinician.
Mobile application (mobile app): Software application that can be executed (run) on a mobile platform (i.e., a handheld commercial off the-shelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform but is executed on a server. 2ff7e9595c
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