Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT04489186

Run by

Byteflies

People needed

26

Starts

2018-12-01

Expected to finish

2019-12-31

Last updated by the study team

2020-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years old
• Confirmed CF diagnosis as determined by a sweat chloride ≥ 60 mmol/L or the presence of two known disease-causing mutations

You may not qualify if…

• Inability to provide written informed consent
• A known allergy to any of the used medical adhesives
• Presence of any type of electronic implanted medical device

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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