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Study of Physiological Signals During and After COPD Exacerbations

NCT04034901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-08-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER

  • Air de Bretagne

    collaborator UNKNOWN

  • Rennes University Hospital

    collaborator OTHER

  • Centre Hospitalier Bretagne Atlantique

    collaborator OTHER

  • Centre Hospitalier de Saint-Malo

    collaborator UNKNOWN

  • Centre Hospitalier de Saint-Brieuc

    collaborator OTHER

  • Biosency

    lead INDUSTRY

Principal Investigators

  • Graziella Brinchault, M.D. · CHU Rennes

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2024-02-06
Completion
2024-02-06

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034901 on ClinicalTrials.gov