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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04923464

Enrollment

Registered

2021-06-11

Start date

2021-06-30

Completion date

2021-12-20

Last updated

2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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/

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame	Description
Number of Steps per day and Variability in Number of Steps per day Over Time	From Day 1 up to Week 12	Number of steps will be reported as mean and variability will be reported as standard deviation (SD).
Number of Coughs per day and Variability in Number of Coughs per day Over Time	From Day 1 up to Week 12	Number of coughs will be reported as mean and variability will be reported as SD.
Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time	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.
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	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.
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	—
Total Activity Count per day and Variability in Total Activity Count per day Over Time	From Day 1 up to Week 12	Total activity count will be reported as mean and variability will be reported as SD.
Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time	From Day 1 up to Week 12	B6ME will be reported as mean and variability will be reported as SD.
Sleep Efficiency and Variability in Sleep Efficiency Over Time	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.
Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time	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.

Countries

United Kingdom, United States

Outcome results