Wearable technology shows promise in assessing physical activity, cough in cystic fibrosis
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Patients receiving treatment for cystic fibrosis wore actigraphy sensors and cough monitoring systems for the majority of a 12-week period, according to a poster presented at the North American Cystic Fibrosis Conference.
“Overall, we noted high adherence to the use of an actigraphy watch and a cough sensor monitor during this 12-week study of people with cystic fibrosis on commercial Trikafta,” Andrew T. Braun, MD, MHS, assistant professor at the University of Wisconsin School of Medicine and Public Health and director of the UW Health adult cystic fibrosis program, told Healio.
In a phase 4, fully decentralized clinical trial, Braun and colleagues assessed 51 patients (mean age, 34.6 ± 11.6 years) with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor (Trikafta, Vertex Pharmaceuticals; ELX/TEZ/IVA) treatment to measure their physical activity and cough frequency captured by wearable devices over 12 weeks, according to the study abstract. At baseline, mean percentage predicted FEV1 was 68.8% ± 23%.
As Healio previously reported, the FDA approved ELX/TEZ/IVA for children aged 6 to 11 years with cystic fibrosis and certain mutations.
Researchers asked patients to wear an actigraphy sensor continuously on their wrist for 12 weeks and an ambulatory cough monitoring system for an entire day once a week.
Compliance with the actigraphy device, defined as the percentage of time patients wore it throughout the study period, served as the study’s primary outcome. Secondary outcomes included the percentage of time patients wore the cough monitoring device and the number and variability of steps and coughs per day.
In order to be included, patients had to have taken ELX/TEZ/IVA for at least 4 weeks prior to the screening, according to researchers.
Five patients discontinued the study, one of whom discontinued due to an adverse event — skin reaction from the device adhesive.
Of the other 46 patients, researchers found a high compliance with the actigraphy device at 91.3% and the cough monitoring device at 84.8%.
The average daily step count ranged between 4,400 to 5,500 steps (standard deviation [SD], 2,300-3,000 steps/day). For daily coughs, the mean ranged from 21 to 33 coughs (SD, 4.1-7 coughs/day), according to the abstract. Braun told Healio this finding was notable.
“Although our study was not primarily focused on assessing the objective cough frequency, it provides an insight into the lived experience that many patients report in our cystic fibrosis clinics,” Braun said. “This data suggests that a person with cystic fibrosis on Trikafta has a daily cough burden that is similar to healthy adults.”
When asked about future studies, Braun said the primary endpoint focus may shift.
“In this era of highly effective cystic fibrosis transmembrane conductance regulator modulators, the use of pulmonary function as a primary endpoint may be less relevant, such that patient-centered outcomes including increased activity levels and cough frequency may be useful as we evaluate new drug therapies,” Braun said.
For more information:
Andrew T. Braun, MD, MHS, can be reached at atbraun@medicine.wisc.edu.