Ireland
--:--IST
Active, not recruiting Not applicable

Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease (BOREAL)

NCT05759247 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-06-19
Last updated
2026-04-23

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

BORA Band (wristband)

BORA Band (wristband): Wristband collecting patient vital signs and activity

Study summary

The purpose of this study is to evaluate the ability of the Bora Care remote monitoring solution to detect early acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient with COPD defined according to the SPLF recommendations, whose level of lung function in a stable state is known (measurement less than 12 months old) * Patient with at least one of the following criteria : * Hospitalized for a COPD exacerbation at the time of enrolment in the study, and having had at least one other exacerbation in the last 12 months * Followed-up and part of the active file of the site, having had at least 2 exacerbations during the last 12 months, including one with hospitalization * COPD patient with at least 2 exacerbations in the last 12 months, including one with hospitalization * Patient having given written informed consent to participate in the study * Patient affiliated to the French social security system Exclusion Criteria * Vulnerable patient (minor, protected adult, prisoner) * Patient unable to use the BoraBand tool and without access to a caregiver * Presence of a comorbidity considered unstable or very severe by the investigator * Patient already participating in another interventional research study

Primary outcome measure(s)

  • Performance of the device for early detection of AECOPD — 12 months
    Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study

Trial sites (1)

FacilityCityRegionStatus
Pneumology Department - Hôpital Cochin Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05759247 on ClinicalTrials.gov ↗ ← All trials in France