A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis
NCT ID: NCT04923464
Last Updated: 2022-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2021-06-30
2021-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participants with an approved CF transmembrane conductance regulator gene (CFTR) genotype according to respective regional labels
Exclusion Criteria
* Non-ambulatory status
18 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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National Jewish Health
Denver, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center
Peoria, Illinois, United States
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Mount Sinai Beth Israel
New York, New York, United States
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
UW School of Medicine & Public Health
Madison, Wisconsin, 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
Countries
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Other Identifiers
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VX20-445-118
Identifier Type: -
Identifier Source: org_study_id
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