Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 2, 2025
Open Peer Review Period: Jul 2, 2025 - Aug 27, 2025
Date Accepted: Nov 26, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Use of a Wearable Device to Monitor People with Chronic Obstructive Pulmonary Disease-BREATH-TRACHER 2: Protocol for an Observational Feasibility Study
ABSTRACT
Background:
Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are a major clinical challenge, often leading to frequent emergency room visits and significantly reducing patients' quality of life. Early detection through wearable devices could facilitate timely interventions at the community level, reducing hospital admissions, and disease-related morbidity and mortality.
Objective:
This study seeks to retrospectively assess the feasibility, sensitivity, and reliability of the Frontier X2 wearable device to monitor clinically relevant physiological signals in volunteers with COPD who experience acute exacerbations.
Methods:
This is a single-center, retrospective, observational feasibility study, monitoring 30 COPD volunteers (mMRC Grades 1- 4) who had been previously hospitalized due to acute exacerbations in the past 12 months. The study will last up to 18 months, focusing on physiological changes occurring within 168 hours prior to any COPD exacerbation. Qualitative data will be gathered through self-administered questionnaires every two weeks to correlate subjective symptoms with device-captured physiological metrics, as well as a separate questionnaire on device adherence and usability.
Results:
Recruitment for this study started in June 2024 and it is anticipated that the data will be collected within 18 months of study initiation with data analysis completed by December 2025. Final results will be published in January 2026.
Conclusions:
The BREATH-TRACHER 2 study will validate the use of the Frontier X2 device in subjects with COPD in home settings. The Frontier X2 device, if successful, has the potential to transform COPD management and support proactive care leading to enhanced clinical outcomes and reduced disease mortality and morbidity. Clinical Trial: ClinicalTrials.gov NCT06419062; https://clinicaltrials.gov/study/NCT06419062
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Copyright
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