NCT04489186

Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Piloting the Clinical Value of Wearable Cardiorespiratory Monitoring for People With Cystic Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Byteflies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cystic Fibrosis (CF) is a disease without a primary cure that requires lifelong care and is characterized by pulmonary exacerbations (PEx). Wearable devices could provide a way for long-term monitoring of disease progression and early signs of PEx to intervene as early as possible, thereby improving long-term outcomes. This in-hospital feasibility study will assess the ability of Byteflies Sensor Dots to collect relevant cardiorespiratory data in people with CF and its compatibility with clinical workflows, 2) identify candidate digital biomarkers, and 3) collect user feedback from patients and healthcare providers.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DEVICE	Wearable device	Multimodal electrocardiography (ECG), bioimpedance (bioZ) and tri-axial accelerometry (ACC) monitoring with a single wearable device (Byteflies Sensor Dot) to derive heart rate, respiratory rate and actigraphy.

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2020-07-28
• Last updated: 2020-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study