Sensitivity, Accuracy, and Reproducibility of Biosensing (mHealth) Devices in Monitoring of Physical Activity and Respiratory Function in Smokers with and Without Respiratory Symptoms or Chronic Obstructive Pulmonary Disease (Preprint)

BACKGROUND Chronic obstructive pulmonary disease (COPD) is a global public health problem, and continuous monitoring is essential for both its management as well as the management of other chronic diseases. Telemonitoring using mobile health (mHealth) devices has the potential to promote self-management, improve control, increase quality of life, and prevent hospital admissions. OBJECTIVE This feasibility and proof-of-concept study aims to assess utility (sensitivity, accuracy, and reproducibility) of biosensing (mHealth) devices in monitoring of physical activity and respiratory function in smokers with and without respiratory symptoms/COPD. METHODS A total of 3 cohorts, with 9 participants in each, used mHealth devices for 90 days while undergoing the current standard of care. These groups were: 9 “non-COPD,” otherwise healthy, smokers; 9 “grey zone” smokers (forced expiratory volume in 1 second/ forced vital capacity ≥0.70 after bronchodilator treatment; COPD Assessment Test ≥10); and 9 smokers diagnosed with Stage 1-3 COPD. Rates of recruitment, retention, and adherence will be measured. Overall, two mHealth devices were utilized in the study: (1) the AnaMed Original Equipment Manufacturer device (OEM) that measures distance, energy expenditure, heart rate, and heart rate variability by using photoplethysmographic method and displays the results on a watchface, smartphone or a tablet, and (2) the Air Next mobile spirometry device portable device that performs spirometric measurements (FEV1, FVC and FEV1/FVC) ratio by a turbine mechanism and displays the results on a smartphone or a tablet. The mHealth devices were compared against industry standards. Additionally, a questionnaire will be administered to assess the participants’ perceptions of the mHealth technologies used. RESULTS The AnaMed device was demonstrated as precise in measuring heart rate, and less so when measuring number of steps and meters. It is unreliable in measuring SpO2. It is easy to use, requires no significant technical support. The Air-Next Spirometer is a simple and very precise instrument for detecting obstructive airway diseases which was confirmed when compared with the industry standard. It is easy to use, which could make it especially useful non-specialized care and in-home setting and other areas. CONCLUSIONS We demonstrated that both devices, AnaMed and AirNext can provide precise measurements or heart rate and spirometric data, and it is feasible to incorporate them into a large-scale study. However, such task would require serious efforts to hire technical staff and to provide additional training for the clinical investigators to take care of technical and logistical issues, i.e. sending reminders, synching devices with smartphones, communication efforts. CLINICALTRIAL ClinicalTrials.gov NCT04081961; https://clinicaltrials.gov/ct2/show/NCT04081961