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Completed

NCT Number: NCT04923464

A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis

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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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

Observational

Primary location

Birmingham Heartlands Hospital, Birmingham, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Forced expiratory volume in 1 second (FEV1) value greater than or equal to (≥) 30 percent predicted
  • Participants with an approved CF transmembrane conductance regulator gene (CFTR) genotype according to respective regional labels

Key Exclusion Criteria:

  • History of solid organ or hematological transplantation
  • Non-ambulatory status

Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

Primary outcomes

  1. Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device

    Time frame: From Day 1 up to Week 12

Secondary outcomes

  1. Compliance With Cough Measurement Device Measured as Percentage of Time a Participant is Wearing the Cough Measurement Device

    Time frame: From Day 1 up to Week 12

  2. Number of Steps per day and Variability in Number of Steps per day Over Time

    Time frame: From Day 1 up to Week 12

    Number of steps will be reported as mean and variability will be reported as standard deviation (SD).

  3. Number of Coughs per day and Variability in Number of Coughs per day Over Time

    Time frame: From Day 1 up to Week 12

    Number of coughs will be reported as mean and variability will be reported as SD.

  4. Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time

    Time frame: From Day 1 up to Week 12

    Time spent above sedentary physical activity will be reported as mean and variability will be reported as SD.

  5. 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 frame: From Day 1 up to Week 12

    Time spent in moderate-to-vigorous physical activity will be reported as mean and variability will be reported as SD.

  6. Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time

    Time frame: From Day 1 up to Week 12

    Time spent in continuous walking bouts will be reported as mean and variability will be reported as SD.

  7. Total Activity Count per day and Variability in Total Activity Count per day Over Time

    Time frame: From Day 1 up to Week 12

    Total activity count will be reported as mean and variability will be reported as SD.

  8. Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time

    Time frame: From Day 1 up to Week 12

    B6ME will be reported as mean and variability will be reported as SD.

  9. Sleep Efficiency and Variability in Sleep Efficiency Over Time

    Time frame: From Day 1 up to Week 12

    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.

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 4 Decentralized Pilot Study With Wearable Technology in Cystic Fibrosis Subjects 18 Years of Age and Older Taking Commercial Elexacaftor/Tezacaftor/Ivacaftor

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2021
Registry last updated
Jan 19, 2022

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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