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This study will evaluate the performance of wearable technology in cystic fibrosis (CF) participants taking commercial Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) utilizing a fully decentralized trial design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELX/TEZ/IVA | CF participants who are currently on a stable regimen of commercially available ELX/TEZ/IVA will be evaluated for the performance of wearable technology devices. Wearable devices include a wrist-worn actigraphy sensor and an ambulatory cough monitoring system. |
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device | From Day 1 up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Cough Measurement Device Measured as Percentage of Time a Participant is Wearing the Cough Measurement Device | From Day 1 up to Week 12 | |
| Number of Steps per day and Variability in Number of Steps per day Over Time | Number of steps will be reported as mean and variability will be reported as standard deviation (SD). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply
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Participants with CF taking commercial ELX/TEZ/IVA will be enrolled in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| Yale New Haven Hospital |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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| From Day 1 up to Week 12 |
| Number of Coughs per day and Variability in Number of Coughs per day Over Time | Number of coughs will be reported as mean and variability will be reported as SD. | From Day 1 up to Week 12 |
| Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time | Time spent above sedentary physical activity will be reported as mean and variability will be reported as SD. | From Day 1 up to Week 12 |
| Time Spent in Moderate-to-Vigorous Physical Activity per day and Variability in Time Spent in Moderate-to-Vigorous Physical Activity per day Over Time | Time spent in moderate-to-vigorous physical activity will be reported as mean and variability will be reported as SD. | From Day 1 up to Week 12 |
| Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time | Time spent in continuous walking bouts will be reported as mean and variability will be reported as SD. | From Day 1 up to Week 12 |
| Total Activity Count per day and Variability in Total Activity Count per day Over Time | Total activity count will be reported as mean and variability will be reported as SD. | From Day 1 up to Week 12 |
| Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time | B6ME will be reported as mean and variability will be reported as SD. | From Day 1 up to Week 12 |
| Sleep Efficiency and Variability in Sleep Efficiency Over Time | Sleep efficiency measurements will be performed using wearable technology which include a wrist-worn actigraphy sensor. Sleep efficiency will be reported as mean and variability will be reported as SD. | From Day 1 up to Week 12 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Central Florida Pulmonary Group, P.A. | Orlando | Florida | 32803 | United States |
| Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center | Peoria | Illinois | 61637 | United States |
| Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center | Boston | Massachusetts | 02114 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Mount Sinai Beth Israel | New York | New York | 10003 | United States |
| Santiago Reyes, M.D. | Oklahoma City | Oklahoma | 73112 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| UW School of Medicine & Public Health | Madison | Wisconsin | 53792 | United States |
| Birmingham Heartlands Hospital | Birmingham | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | United Kingdom |
| St. James University Hospital | Leeds | United Kingdom |
| Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital | London | United Kingdom |
| Wythenshawe Hospital | Manchester | United Kingdom |
| Southampton General Hospital | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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