Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

NCT04489186 — Not applicable, Completed, 26 participants, Byteflies

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

Registry	NCT04489186
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, device feasibility
Enrollment	26 (Actual)
Sponsor	Byteflies (Industry); collaborators: University Hospitals Cleveland Medical Center
Conditions	Cystic Fibrosis
Interventions	Wearable device (Device)
Dates	start 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 in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
All subjects	Experimental	Device: Wearable device	Single arm feasibility study with a wearable device intervention for cardiorespiratory and activity monitoring in subjects with cystic fibrosis.

Wearable device (Device), also known as Byteflies Sensor Dot: 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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University Hospitals Cleveland Medical Center	Cleveland, Ohio	United States

+Investigators

Erica A Roesch, MD, Principal investigator, University Hospitals Cleveland Medical Center