Monitoring vital signs in patients with idiopathic pulmonary fibrosis
Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)
This study is testing if using a wristband to track vital signs at home can help people with idiopathic pulmonary fibrosis catch flare-ups earlier than usual.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biosency Industry-sponsored |
| Locations | 1 site (Rennes) |
| Trial ID | NCT06445686 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of using remote monitoring devices to detect acute exacerbations of idiopathic pulmonary fibrosis (IPF) earlier. Patients will be equipped with a Bora Band® wristband to measure vital signs at home, along with a Bora Box® Gateway for real-time data uploading. Conventional clinical follow-ups will continue alongside this monitoring. The collected data will be analyzed to identify key metrics that could trigger alerts for exacerbations before patients report symptoms or consult their pulmonologist.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stable idiopathic pulmonary fibrosis who require ambulatory oxygen therapy and have not experienced recent hospitalizations or exacerbations.
Not a fit: Patients currently receiving permanent oxygen therapy or those with unstable co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and intervention for patients experiencing exacerbations of idiopathic pulmonary fibrosis.
How similar studies have performed: While remote monitoring for chronic conditions is gaining traction, this specific approach for idiopathic pulmonary fibrosis exacerbation detection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rennes
- Chru Pontchaillou — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Stéphane JOUNEAU, MD — CHRU PONTCHAILLOU Rennes
- Study coordinator: Alexis TOULLEC
- Email: clinical@biosency.com
- Phone: 02 21 65 70 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.