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Study of Physiological Signals During and After COPD Exacerbations (DACRE)

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ClinicalTrials.gov Identifier: NCT04034901
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborators:
Slb Pharma
Air de Bretagne
Rennes University Hospital
Centre Hospitalier Bretagne Atlantique
Centre Hospitalier de Saint-Malo
Centre Hospitalier de Saint-Brieuc
Information provided by (Responsible Party):
Biosency

Brief 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. 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


Condition or disease Intervention/treatment Phase
COPD COPD Exacerbation Device: Monitoring of cardiorespiratory parameters with BORA Band Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Collecte de données Physiologiques en Continu Chez Des Patients en Insuffisance Respiratoire Pendant et après un épisode d'Exacerbation de BPCO
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Monitoring of cardiorespiratory parameters
Monitoring of cardiorespiratory parameters with BORA Band
Device: Monitoring of cardiorespiratory parameters with BORA Band

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Connected wrist-worn pulse oximeter adherence [ Time Frame: 2 months ]
    The mean duration of bora band utilization will be measured (mean number of days and mean number of hours per day)

  2. Patient satisfaction [ Time Frame: 2 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034901


Contacts
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Contact: Marie Pirotais, M.Sc. 973248810 ext +33 marie.pirotais@biosency.com
Contact: Anne-Laure Serandour, Pharm.D. 299121962 ext +33 al.serandour@slbpharma.com

Sponsors and Collaborators
Biosency
Slb Pharma
Air de Bretagne
Rennes University Hospital
Centre Hospitalier Bretagne Atlantique
Centre Hospitalier de Saint-Malo
Centre Hospitalier de Saint-Brieuc
Investigators
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Principal Investigator: Graziella Brinchault, M.D. CHU RENNES

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Responsible Party: Biosency
ClinicalTrials.gov Identifier: NCT04034901     History of Changes
Other Study ID Numbers: 2019-A00642-55
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases