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| Name | Class |
|---|---|
| University Hospitals Cleveland Medical Center | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | Single arm feasibility study with a wearable device intervention for cardiorespiratory and activity monitoring in subjects with cystic fibrosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Quality of calculated vital signs: respiratory rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica A Roesch, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
This is a device feasibility study. The results will be shared via a publication.
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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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.
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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 |
| Cough detection | Assess if cough events can be derived from the wearable data, as compared to self-reported outcomes. | Up to 24 hours |
| 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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |