Actively Recruiting

Age: 18Years +
All Genders
NCT06445686

Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation.

Led by Biosency · Updated on 2024-08-15

30

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

B

Biosency

Lead Sponsor

R

Rennes University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of this study is to assess the feasibility of early detection of acute exacerbations of idiopathic pulmonary fibrosis by the remote monitoring of vital signs. The main question the study aims to answer is: Could a remote monitoring device allow for earlier detection of exacerbations with individualized monitoring and continuous data collection? All patients will receive conventional clinical follow-up based on their health status and clinical recommendations. At the same time, they will benefit from the Bora Care® medical remote monitoring device.

CONDITIONS

Official Title

Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years of age, ideally 50% male and 50% female
  • Patient with IPF with a known level of respiratory function (EFR and blood gas less than 3 months)
  • Stable patient, i.e. without hospitalisation or exacerbation in the last 3 months
  • Patient desaturating at 6MW in ambient air (AA) and requiring ambulatory oxygen therapy (SpO2 AA  88%)
  • Patient not receiving walking or permanent oxygen therapy at baseline
  • Informed patient who has signed consent
  • Patient affiliated to a social security scheme
  • Patient not monitored by a home healthcare provider other than Air de Bretagne.
Not Eligible

You will not qualify if you...

  • Vulnerable patient
  • Patient receiving ambulatory or permanent oxygen therapy at baseline
  • Patient already seen with another healthcare provider (e.g. OSAS)
  • Patient unable to use the Bora Band4 tool and without access to a caregiver
  • Presence of co-morbidity considered unstable or very severe by the investigator
  • Patient protected, under guardianship or incapable of giving free and informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chru Pontchaillou

Rennes, France, 35000

Actively Recruiting

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Research Team

A

Alexis TOULLEC

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. | DecenTrialz