Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: Wearable device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: The study is intended to evaluate the feasibility of a prototype wearable device for continuous cardiorespiratory monitoring in an inpatient and outpatient population with CF in preparation of a larger ambulatory clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br>Single arm feasibility study with a wearable device intervention for cardiorespiratory and activity monitoring in subjects with cystic fibrosis. | Device: Wearable device<br>* 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.<br>* Other names: Byteflies Sensor Dot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor Dot usability | Assessed via user (healthcare professional and patient) surveys. | Up to 24 hours | 
| Sensor Dot data quality | Evaluated by visual examination of recorded electrocardiography (ECG), bioimpedance (bioZ), and accelerometry (ACC) data. | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of calculated vital signs: heart rate | Compare Sensor Dot heart rate (derived from ECG) in beats-per-minute against heart rate as measured by standard hospital equipment. | Up to 24 hours | 
| Quality of calculated vital signs: respiratory rate | Compare Sensor Dot respiratory rate (derived from bioZ) in breaths-per-minute against respiratory rate as measured by standard hospital equipment. | Up to 24 hours | 
| Cough detection | Assess if cough events can be derived from the wearable data, as compared to self-reported outcomes. | Up to 24 hours | 
| Screen for candidate digital biomarkers in CF | Evaluate correlations between the recorded vital sign data (Sensor Dot) and CF severity scores derived from routine pulmonary function testing (PFT, based on Global Lung Function Initiative) and PEx. | Up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wearable, cardiorespiratory monitoring, digital medicine