Evaluation of the Use of a Remote Monitoring and Follow-u... | NCT05759247

ID	Type	Description	Link
2021-A02146-35	Other Identifier	ID-RCB Number

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2023Actual

Primary Completion Date

Jan 29, 2026Actual

Completion Date

Jun 29, 2026Estimated

First Submitted Date

Jan 19, 2023

First Submission Date that Met QC Criteria

Mar 6, 2023

First Posted Date

Mar 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2026

Last Update Posted Date

Apr 23, 2026Actual

Name	Class
Biosency	INDUSTRY
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Worldwide, COPD has been increasing for 20 years with nearly 300 million patients, i.e. 4 to 10% of the adult population (7.5% in France). According to the WHO, it is now the fourth leading cause of death in the world.

Acute exacerbations of COPD (worsening of symptoms requiring an increase in treatment) represent frequent events in the course of the disease and the consequences are significant for the patient in terms of vital prognosis, deterioration of respiratory function, impact on quality life and for the health system in terms of cost. Missed diagnosis and delayed treatment are associated with impaired outcomes. The prevention and early treatment of acute exacerbations of COPD therefore have a major role in the management of COPD patients and could be facilitated by telemonitoring tools.

The purpose of the present study is to validate the interest of remote monitoring of various parameters (cardio-respiratory, environmental, symptom questionnaires) to predict and detect early the occurrence of acute exacerbations of COPD.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Name	Type	Description	Arm Group Labels	Other Names
BORA Band (wristband)	Device	Wristband collecting patient vital signs and activity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance of the device for early detection of AECOPD	Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study	12 months

Secondary Outcomes

Measure	Description	Time Frame
Relation between AECOPD and measured parameters	Correlation between measured parameters and observed AECOPD events	12 months
Compliance	Wristband wearing duration during the follow-up period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Nicolas ROCHE, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Pneumology Department - Hôpital Cochin		Paris		75014	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms