Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Byteflies

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: Wearable device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04489186

BF0001

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

All subjects

Experimental group

Description:

Single arm feasibility study with a wearable device intervention for cardiorespiratory and activity monitoring in subjects with cystic fibrosis.

Treatment:

Device: Wearable device