Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Wearable device

• Registration Number: NCT04489186
• Lead Sponsor: Byteflies

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-28
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Wearable device	Single arm feasibility study with a wearable device intervention for cardiorespiratory and activity monitoring in subjects with cystic fibrosis.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States