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Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wearable device

About this trial

This is an interventional device feasibility trial for Cystic Fibrosis focused on measuring wearable, cardiorespiratory monitoring, digital medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

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

Outcomes

Primary Outcome Measures

Sensor Dot usability

Assessed via user (healthcare professional and patient) surveys.

Sensor Dot data quality

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

Secondary Outcome Measures

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.

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.

Cough detection

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

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.

Full Information

NCT ID

NCT04489186

First Posted

July 22, 2020

Last Updated

July 27, 2020

Sponsor

Byteflies

Collaborators

University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04489186

Brief Title

Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Byteflies

Collaborators

University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

wearable, cardiorespiratory monitoring, digital medicine

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All subjects

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Wearable device

Other Intervention Name(s)

Byteflies Sensor Dot

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sensor Dot usability

Description

Assessed via user (healthcare professional and patient) surveys.

Time Frame

Up to 24 hours

Title

Sensor Dot data quality

Description

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

Time Frame

Up to 24 hours

Secondary Outcome Measure Information:

Title

Quality of calculated vital signs: heart rate

Description

Compare Sensor Dot heart rate (derived from ECG) in beats-per-minute against heart rate as measured by standard hospital equipment.

Time Frame

Up to 24 hours

Title

Quality of calculated vital signs: respiratory rate

Description

Compare Sensor Dot respiratory rate (derived from bioZ) in breaths-per-minute against respiratory rate as measured by standard hospital equipment.

Time Frame

Up to 24 hours

Title

Cough detection

Description

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

Time Frame

Up to 24 hours

Title

Screen for candidate digital biomarkers in CF

Description

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.

Time Frame

Up to 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erica A Roesch, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This is a device feasibility study. The results will be shared via a publication.

Learn more about this trial

Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

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