NCT06445686 Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation.
| NCT ID | NCT06445686 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biosency |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-06-17 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Stéphane JOUNEAU, MD
PRINCIPAL INVESTIGATOR
CHRU PONTCHAILLOU Rennes
Frequently Asked Questions
Who can join the NCT06445686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06445686 currently recruiting?
Yes, NCT06445686 is actively recruiting participants. Contact the research team at clinical@biosency.com for enrollment information.
Where is the NCT06445686 trial being conducted?
This trial is being conducted at Rennes, France.
Who is sponsoring the NCT06445686 clinical trial?
NCT06445686 is sponsored by Biosency. The principal investigator is Stéphane JOUNEAU, MD at CHRU PONTCHAILLOU Rennes. The trial plans to enroll 30 participants.