COPDDACRENCT04034901
Study of Physiological Signals During and After COPD Exacerbations
A study testing Monitoring of cardiorespiratory parameters with BORA Band in people with COPD and COPD Exacerbation, run by Biosency at 1 site in France.
Trial summary
Background : Acute exacerbations of COPD (Chronic Obstructive Pulmonary Disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD Exacerbation
- What is being tested?
- Monitoring of cardiorespiratory parameters with BORA Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2021to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 known or suspected to suffer from COPD
- patient admitted in pulmonology unit for COPD exacerbation
- patient accepting to use BORA Band during and after hospitalization
- patient accepting to be followed by the partner health care provider for this study (Air de Bretagne)
- patient able to understand French and express their informed consent
- patient affiliated to social security
Who cannot join
- patient is intubated
- patient already followed by a health care provider other than Air de Bretagne
- investigator assesses that the patient will have difficulties following the protocol
- patient already enrolled in another interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collecte de données Physiologiques en Continu Chez Des Patients en Insuffisance Respiratoire Pendant et après un épisode d'Exacerbation de BPCO
Background : Acute exacerbations of COPD (Chronic Obstructive Pulmonary Disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. It is therefore crucial to prevent these exacerbations from occurring.
Aim of the study : Investigate how cardiorespiratory parameters of COPD patients differ between exacerbation phases and their nominal state in order to identify predictors of COPD exacerbations.
Read more
Study design : Patients admitted at one of the investigation centers on a suspicion of COPD exacerbation will be enrolled on a voluntary basis. Enrolled patients' cardiorespiratory parameters will be monitored with a connected wrist-worn pulse oximeter (BORA Band) during the hospitalisation phase and one month after they have been discharged.
Setting : 4 investigative centers across Brittany
Patients : 50 patients will be enrolled in the study
- Conditions
- COPD, COPD Exacerbation
- Being tested
- Monitoring of cardiorespiratory parameters with BORA Band
- 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.
Monitoring of cardiorespiratory parameters with BORA BandDevice
The subjects will continuously wear a connected wrist-worn pulse oximeter which will remotely collect the following measurements :
- Activity
- Step count
- Heart rate
- Respiratory rate
- Skin temperature
- SpO2
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of cardiorespiratory parameters | Experimental | Monitoring of cardiorespiratory parameters with BORA Band Receives: Device: Monitoring of cardiorespiratory parameters with BORA Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of heart rate during and after a COPD acute exacerbation
Average heart rate in beats per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Measured: 2 months
Variation of respiratory rate during and after a COPD acute exacerbation
Average respiratory rate in cycles per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Measured: 2 months
Variation of SpO2 during and after a COPD acute exacerbation
Average SpO2 in percent during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Measured: 2 months
Variation of skin temperature during and after a COPD acute exacerbation
Average skin temperature in celcius during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Measured: 2 months
Variation of patient activity during and after a COPD acute exacerbation
Average patient activity measured in activity duration per day during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Measured: 2 months
Secondary outcomes (2)
Connected wrist-worn pulse oximeter adherence
The mean duration of bora band utilization will be measured (mean number of days and mean number of hours per day)
Measured: 2 months
Patient satisfaction
the patient satisfaction with the connected wrist-worn pulse oximeter will be assessed using a series of yes or no questions about the comfort, the acceptability, the ease of use and the size of the device.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start19 Feb 2021
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosency
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, Air de Bretagne, Rennes University Hospital, Centre Hospitalier Bretagne Atlantique, Centre Hospitalier de Saint-Malo, Centre Hospitalier de Saint-Brieuc
- Responsible party
- Sponsor
- Investigators
- Graziella Brinchault, M.D., Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034901
- Sponsor's protocol ID
- 2019-A00642-55
- Acronym
- DACRE
- Status last verified
- Aug 2024
- First submitted
- 28 Jun 2019
- Last updated
- 15 Aug 2024
- 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 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecte de données Physiologiques en Continu Chez Des Patients en Insuffisance Respiratoire Pendant et après un épisode d'Exacerbation de BPCO
- ClinicalTrials.gov ID
- NCT04034901
- Acronym / sponsor ID
- DACRE / 2019-A00642-55
- Conditions
- COPD, COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BiosencyIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, Air de Bretagne, Rennes University Hospital, Centre Hospitalier Bretagne Atlantique, Centre Hospitalier de Saint-Malo, Centre Hospitalier de Saint-Brieuc
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 26 Jul 2019 (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.
Background : Acute exacerbations of COPD (Chronic Obstructive Pulmonary Disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. It is therefore crucial to prevent these exacerbations from occurring.
Aim of the study : Investigate how cardiorespiratory parameters of COPD patients differ between exacerbation phases and their nominal state in order to identify predictors of COPD exacerbations.
Study design : Patients admitted at one of the investigation centers on a suspicion of COPD exacerbation will be enrolled on a voluntary basis. Enrolled patients' cardiorespiratory parameters will be monitored with a connected wrist-worn pulse oximeter (BORA Band) during the hospitalisation phase and one month after they have been discharged.
Setting : 4 investigative centers across Brittany
Patients : 50 patients will be enrolled in the study
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring of cardiorespiratory parameters | Experimental | Device: Monitoring of cardiorespiratory parameters with BORA BandMonitoring of cardiorespiratory parameters with BORA Band |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient known or suspected to suffer from COPD
- patient admitted in pulmonology unit for COPD exacerbation
- patient accepting to use BORA Band during and after hospitalization
- patient accepting to be followed by the partner health care provider for this study (Air de Bretagne)
- patient able to understand French and express their informed consent
Key exclusion criteria (4 listed)
- patient is intubated
- patient already followed by a health care provider other than Air de Bretagne
- investigator assesses that the patient will have difficulties following the protocol
- patient already enrolled in another interventional 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 |
|---|---|---|
| Monitoring of cardiorespiratory parameters with BORA BandThe subjects will continuously wear a connected wrist-worn pulse oximeter which will remotely collect the following measurements : * Activity * Step count * Heart rate * Respiratory rate * Skin temperature * SpO2 | Device | Monitoring of cardiorespiratory parameters |
Primary outcome
Variation of heart rate during and after a COPD acute exacerbation
Time frame: 2 months
Average heart rate in beats per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Variation of respiratory rate during and after a COPD acute exacerbation
Time frame: 2 months
Average respiratory rate in cycles per minute during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Variation of SpO2 during and after a COPD acute exacerbation
Time frame: 2 months
Average SpO2 in percent during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Variation of skin temperature during and after a COPD acute exacerbation
Time frame: 2 months
Average skin temperature in celcius during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
Variation of patient activity during and after a COPD acute exacerbation
Time frame: 2 months
Average patient activity measured in activity duration per day during and after COPD exacerbation will be assessed thanks to a wrist-worn connected pulse oximeter
2 secondary outcomes
Connected wrist-worn pulse oximeter adherence
Time frame: 2 months
Patient satisfaction
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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.
Graziella Brinchault, M.D. principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of cardiorespiratory parameters with BORA Band in people with COPD and COPD Exacerbation, run by Biosency 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 6 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: finished, as of the sponsor's last update on 15 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variation of heart rate during and after a COPD acute exacerbation (time frame: 2 months). The study lists 5 primary outcomes in all. 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 15 Aug 2024.