UnknownNot Applicable

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

France30 participantsStarted 2024-06-17

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess the feasibility of early detection of acute IPF exacerbations with the Bora Care® Vital Signs Remote Monitoring Solution.

Timeframe: 1 year

Trial details

NCT IDNCT06445686

SponsorBiosency

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02

Contact for this trial

Alexis TOULLEC

02 21 65 70 01 clinical@biosency.com

View on ClinicalTrials.gov More Idiopathic Pulmonary Fibrosis trials