Chronic Obstructive Pulmonary DiseaseBOREALNCT05759247
Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease (BOREAL)
A study testing BORA Band (wristband) in people with Chronic Obstructive Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BORA Band (wristband)
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2023to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease
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).
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BORA Band (wristband)
- Keywords
- COPD, acute exacerbation, prevention, early detection
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BORA Band (wristband)Device
Wristband collecting patient vital signs and activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the device for early detection of AECOPD
Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study
Measured: 12 months
Secondary outcomes (8)
Relation between AECOPD and measured parameters
Correlation between measured parameters and observed AECOPD events
Measured: 12 months
Compliance
Wristband wearing duration during the follow-up period
Measured: 12 months
Description of AECOPD
Number, duration, severity of AECOPD events observed during the study
Measured: 12 months
Quality of Life CAT
Quality of life questionnaire CAT at baseline and after 6 and 12 months - CAT : COPD Assement Test, 8 items, range 0 (no impact of COPD) - 40 (worst impact of COPD)
Measured: 12 months
Quality of Life EQ5D5L
Quality of life questionnaire EQ5D5L at baseline and after 6 and 12 months - EQ5S5L : five dimensions, 5 levels each, final result expressed as a 5-digit number that describes the patient's health state (worsens with increasing score)
Measured: 12 months
Satisfaction
meCUE questionnaire after 12 months
Measured: 12 months
Symptoms - EXASCORE questionnaire
EXASCORE questionnaire at baseline and after 6 and 12 months. EXASCORE: 2 dimensions, 8 items, range 0-32 (the highest the worst)
Measured: 12 months
Symptoms - EXACT E-RS questionnaire
EXACT E-RS questionnaire at baseline and after 6 and 12 months. EXACT E-RS : 4 sections, 14 items, range 0-100 (the highest the worst)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start19 Jun 2023
- Primary completion29 Jan 2026
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Biosency, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759247
- Sponsor's protocol ID
- APHP211098
- Other IDs
- 2021-A02146-35
- Acronym
- BOREAL
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05759247
- Acronym / sponsor ID
- BOREAL / APHP211098
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, acute exacerbation, prevention, early detection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Biosency, URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 :
- Patient having given written informed consent to participate in the study
- Patient affiliated to the French social security system
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BORA Band (wristband)Wristband collecting patient vital signs and activity | Device | – |
Primary outcome
Performance of the device for early detection of AECOPD
Time frame: 12 months
Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study
8 secondary outcomes
Relation between AECOPD and measured parameters
Time frame: 12 months
Compliance
Time frame: 12 months
Description of AECOPD
Time frame: 12 months
Quality of Life CAT
Time frame: 12 months
Quality of Life EQ5D5L
Time frame: 12 months
Satisfaction
Time frame: 12 months
Symptoms - EXASCORE questionnaire
Time frame: 12 months
Symptoms - EXACT E-RS questionnaire
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas ROCHE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BORA Band (wristband) in people with Chronic Obstructive Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the device for early detection of AECOPD (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.