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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06445686
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Biosency
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stéphane JOUNEAU, MD
Principal Investigator Affiliation	CHRU PONTCHAILLOU Rennes
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Additional Details

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. To do this, they will be equipped with a Bora Band® connected wristband that measures vital signs at home, and the Bora Box® Gateway that ensures connectivity and allows automatic data uploading in real time to the Bora Connect® data visualization platform. The home healthcare provider Air de Bretagne will be involved in the study to support each patient in the use of the connected wristband. At the end of the follow-up period, the collected data will be retrospectively analysed to identify the most relevant metrics within the time series of vital signs for early detection of Idiopathic Pulmonary Fibrosis exacerbations, and to assess the feasibility of early detection of Idiopathic Pulmonary Fibrosis exacerbations using a score that could trigger an alert prior to the date the patient reports clinical signs or the date the pulmonologist is consulted for exacerbation of Idiopathic Pulmonary Fibrosis. Procedure:

- Inclusion Visit : 6-minute walk test and prescription of oxygen therapy.

- Home Installation Visit: installation of oxygen therapy by Air de Bretagne and setup of the Bora Connect® bracelet and Bora Box® Gateway.

- Follow-up Visit with the Pulmonologist at 6 months (M6): routine examinations, satisfaction questionnaire, and quality of life questionnaire.

- End of Study Visit with the Pulmonologist at 12 months (M12): routine examinations, satisfaction questionnaire, and quality of life questionnaire.

(In case of exacerbation, the follow-up will be extended by 3 months to collect post-exacerbation data.)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.