Study of Physiological Signals During and After COPD Exacerbations

NCT04034901 | Completed

• 1 other identifier: 2019-A00642-55
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; COPD Exacerbation

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  2 months

Secondary Outcomes (2)

• Connected wrist-worn pulse oximeter adherence

  2 months

• Patient satisfaction

  2 months

Study Arms (1)

Monitoring of cardiorespiratory parameters

EXPERIMENTAL

Monitoring of cardiorespiratory parameters with BORA Band

Device: Monitoring of cardiorespiratory parameters with BORA Band

Interventions

Monitoring of cardiorespiratory parameters with BORA Band DEVICE

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

Monitoring of cardiorespiratory parameters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosency: lead
• Slb Pharma: collaborator
• Air de Bretagne: collaborator
• Rennes University Hospital: collaborator
• Centre Hospitalier Bretagne Atlantique: collaborator
• Centre Hospitalier de Saint-Malo: collaborator
• Centre Hospitalier de Saint-Brieuc: collaborator

Study Sites (1)

Chru Pontchaillou

Rennes, 35000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Graziella Brinchault, M.D.

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 26, 2019
• Study Start: February 19, 2021
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)