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OpenTrials
Completed

NCT Number: NCT04489186

Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Byteflies Sensor Dot

Primary outcomes

  1. Sensor Dot usability

    Time frame: Up to 24 hours

    Assessed via user (healthcare professional and patient) surveys.

  2. Sensor Dot data quality

    Time frame: Up to 24 hours

    Evaluated by visual examination of recorded electrocardiography (ECG), bioimpedance (bioZ), and accelerometry (ACC) data.

Secondary outcomes

  1. Quality of calculated vital signs: heart rate

    Time frame: 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.

  2. Quality of calculated vital signs: respiratory rate

    Time frame: 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.

  3. Cough detection

    Time frame: Up to 24 hours

    Assess if cough events can be derived from the wearable data, as compared to self-reported outcomes.

  4. Screen for candidate digital biomarkers in CF

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Byteflies

Industry

Collaborators

  • University Hospitals Cleveland Medical Center

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2020
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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