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

Launched by BIOSENCY · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients with Idiopathic Pulmonary Fibrosis (IPF) by using a remote monitoring device called Bora Care®. The main goal is to see if this device can help doctors detect when a patient's condition worsens (called an acute exacerbation) earlier than usual. Participants in the study will continue to receive their regular medical check-ups, but they will also use this monitoring device to track their vital signs, which can provide important information about their health.

To be eligible for this trial, participants need to be over 18 years old, have been diagnosed with IPF, and have stable health without any recent hospitalizations or flare-ups. It's particularly aimed at those who may need extra support, like patients who experience low oxygen levels during physical activity. The study is currently recruiting participants, and those who join can expect to use the Bora Care® device while still receiving their usual medical care. This trial offers a potential new way to monitor and improve health outcomes for people living with IPF.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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 Band® 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

Trial Officials