(162) The Acceptability and Usability of a Soft, Flexible, Wearable Device for Cough Detection in Pediatric Cystic Fibrosis Patients

Background: Cough is a common symptom in cystic fibrosis (CF), and an increase in cough is an important sign of worsening lung disease and of pulmonary exacerbation, the most common cause of hospitalization in people with CF. Objective monitoring of cough could be an important outcome measure for clinical trials, especially in children too young to do pulmonary function tests. To date, there are no accurate, objective methods to quantify the frequency, severity, and duration of cough. Devices that have been tested to measure cough are neither highly reliable nor user-friendly. We developed a mechano-acoustic sensor (MAS): a 4.8 cm x 2.8 cm (1 inch) long, thin, lightweight, stretchable, wireless device that adheres easily and securely to the skin surface and is worn at the base of the neck. The device was validated in adults being monitored for COVID-19. This study evaluated usability and acceptability to children and their parents.

Methods: In Cohort 1, a small, flexible, fully wireless accelerometer-based MAS was applied to the suprasternal notch of children with CF using gentle adhesives. Participants were asked to perform activities that included forced coughs while sitting, laying down, and performing activities such as jumping or jogging, and other pharyngolaryngeal activities such as swallowing, speaking, and throat clearing. The sessions were about 30 minutes long on average. In Cohort 2, participants were asked to test the device for longer period of wearable time (4-6 hours) in various settings, including outpatient clinics, inpatient rooms, and outside clinic/at-home environments. Upon completion, all participants from Cohorts 1 and 2 were asked to fill out the Acceptability and Usability Questionnaire, which consisted of 6 questions on a 4-point Likert scale.

Results: Cohort 1 included 21 children aged 3-18 (mean=9.25, SD=4.85) years and Cohort 2 included 12 children aged 7-18 (mean= 12.15, SD =4.42) years. From 31(94%) questionnaires returned, 35.5% of participants strongly agreed, and 61.3% agreed to the statement "I (or my child) like(s) wearing the cough sensor." Similarly, most participants found the cough sensor easy to use (74.2% strongly agreed and 25.8% agreed) and comfortable to wear (64.5% strongly agreed and 29.0% agreed). However, participants found the adhesive sticker hard to take off and the device's size being too obvious or large.

Conclusions: While both qualitative and quantitative acceptability and usability data were overall positive, we have redesigned the cough sensor for comfort and are continuing enrollment. The new sensor, 3.5cm x 1.6cm x .8cm high, is smaller and sits lower on the neck so participants can better conceal it underneath clothing (Figure 1). We are providing universal adhesive remover wipes to all participants. Future work includes long-term monitoring (1-2 weeks) of pulmonary exacerbations using the new devices and further assessing the usability and acceptability from participants.

Acknowledgements:

Funding: CFF MCCOLL20A0-I

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