Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

NCT04489186 | Completed FDA Device

• 1 other identifier: BF0001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

wearable; cardiorespiratory monitoring; digital medicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Quality of calculated vital signs: heart rate

  Up to 24 hours

• Quality of calculated vital signs: respiratory rate

  Up to 24 hours

• Cough detection

  Up to 24 hours

• Screen for candidate digital biomarkers in CF

  Up to 24 hours

Study Arms (1)

All subjects

EXPERIMENTAL

Single arm feasibility study with a wearable device intervention for cardiorespiratory and activity monitoring in subjects with cystic fibrosis.

Device: Wearable device

Interventions

Wearable device 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.

Also known as: Byteflies Sensor Dot

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Confirmed CF diagnosis as determined by a sweat chloride ≥ 60 mmol/L or the presence of two known disease-causing mutations

You may not qualify if:

• 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

Sponsors & Collaborators

• Byteflies: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Erica A Roesch, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: December 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)