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

NCT06445686 | Recruiting

• 1 other identifier: 2023-A02063-42
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis; Remote monitoring; Exacerbation; Prevention

Outcome Measures

Primary Outcomes (1)

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

  Correlation between changes in time series of vital signs (heart rate, respiratory rate) in patients in the days prior to diagnosis of exacerbation of Idiopathic Pulmonary Fibrosis and onset of exacerbation of Idiopathic Pulmonary Fibrosis.

  1 year

Secondary Outcomes (5)

• Identify relevant metrics in the signals collected by the Bora Care® solution for early detection of medical events.

  1 year

• Assess compliance with the use of the Bora Care® bracelet by patients.

  1 year

• Assess patient satisfaction and reassurance provided by the remote monitoring solution

  1 year

• Assess the satisfaction and adherence of healthcare professionals to the remote monitoring solution.

  1 year

• Assess side effects related to the Bora Care® device.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Idiopathic Pulmonary Fibrosis with indication for ambulatory oxygen therapy (Sp02 (peripheral oxygen saturation) ≤ 88% in ambient air during 6-minute walk test)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosency: lead
• Rennes University Hospital: collaborator
• Air de Bretagne: collaborator
• Association Fibroses Pulmonaires France: collaborator

Study Sites (1)

Chru Pontchaillou

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stéphane JOUNEAU, MD

  CHRU PONTCHAILLOU Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis TOULLEC

CONTACT

02 21 65 70 01; clinical@biosency.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 6, 2024
• Study Start: June 17, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)