Cystic Fibrosis
Conditions
Keywords
wearable, cardiorespiratory monitoring, digital medicine
Brief 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.
Interventions
DEVICEWearable 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.
Sponsors
University Hospitals Cleveland Medical Center
Byteflies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensor Dot usability | Up to 24 hours | Assessed via user (healthcare professional and patient) surveys. |
| Sensor Dot data quality | Up to 24 hours | Evaluated by visual examination of recorded electrocardiography (ECG), bioimpedance (bioZ), and accelerometry (ACC) data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of calculated vital signs: heart rate | Up to 24 hours | Compare Sensor Dot heart rate (derived from ECG) in beats-per-minute against heart rate as measured by standard hospital equipment. |
| Quality of calculated vital signs: respiratory rate | Up to 24 hours | Compare Sensor Dot respiratory rate (derived from bioZ) in breaths-per-minute against respiratory rate as measured by standard hospital equipment. |
| Cough detection | Up to 24 hours | Assess if cough events can be derived from the wearable data, as compared to self-reported outcomes. |
| Screen for candidate digital biomarkers in CF | Up to 24 hours | 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. |
Countries
United States
Outcome results
None listed