Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489186
• Other study ID #: BF0001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: Byteflies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Wearable 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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Byteflies	University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensor Dot usability	Assessed via user (healthcare professional and patient) surveys.	Up to 24 hours
Primary	Sensor Dot data quality	Evaluated by visual examination of recorded electrocardiography (ECG), bioimpedance (bioZ), and accelerometry (ACC) data.	Up to 24 hours
Secondary	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
Secondary	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
Secondary	Cough detection	Assess if cough events can be derived from the wearable data, as compared to self-reported outcomes.	Up to 24 hours
Secondary	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