Abstract Rationale Cystic fibrosis (CF) is an autosomal recessive condition with morbidity and mortality primarily caused by chronic progressive pulmonary disease. Between encounters, clinicians rely on patients with CF to recognize and report symptoms concerning for a pulmonary exacerbation. Wearable devices can remotely obtain objective data such as breath sounds. This pilot study was conducted to determine the feasibility and acceptability of using a wearable biosensor to detect abnormal breath sounds in adults with CF in an ambulatory setting. Methods Patients ≥ 18 years old with CF were recruited from multiple outpatient clinics and were given the RESP Biosensor made by Strados Labs. Upon enrollment, participants performed spirometry. Each week for three months, participants were instructed to complete the Cystic Fibrosis Respiratory Symptom Diary-Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) survey and two four-hour recordings. At the end of the study, participants filled out a user experience survey and their adherence to the study protocol was determined. We used a descriptive analysis with count (%) for categorical variables and median (IQR) for continuous variables. Results Twelve participants were enrolled with a median age of 34 (26, 44) years old. Two-thirds were female (8, 67%) and three-quarters identified as White, non-Hispanic (9, 75%). Most reported at least one pulmonary exacerbation in the past year (7, 58%). Spirometry showed a median ppFEV1 80 (66, 100), ppFVC 109 (89, 114), and FEV1/FVC 68 (59, 76). Initial CFRSD-CRISS scores averaged at 8 (0, 11) indicating a low symptom burden. Participants completed 100% (98%, 100%) of weekly surveys and 86% (67%, 96%) of their expected recordings. Our cohort reported high levels of satisfaction with the wearable device with most agreeing or strongly agreeing that it was comfortable (7, 58%), easy to put on and remove (8, 67%), non-interfering with daily activities (10, 83%), and secure during use (11, 92%). The majority felt they could forget they were wearing the device (9, 75%), although one-third (4, 33%) reported the adhesive irritated their skin. Conclusion Over a three-month period, adults with CF were adherent to weekly surveys and recordings using the RESP Biosensor. The wearable device was overall well-received. Our pilot study results indicate that wearable devices are reasonable to give adults with CF who require close monitoring given their ease of use. We are currently undergoing further analysis to determine whether survey data correlates to recorded abnormal breath sounds. This abstract is funded by: Strados Labs
Sarilla et al. (Fri,) studied this question.