NCT05246449

Evaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP

Multi-centre, National, Randomised, Exploratory Study Evaluating the Benefit of an Individualised Treatment Plan(VitalCare) Compared to Standard of Care, in Obstructive Sleep Apnoea Patients Treated With CPAP/APAP

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

According to a stratification procedure, the objective of a personalised care plan (VitalCare) is to identify points for improvement since the early stage of the patient's pathway of CPAP/APAP treatment and to adjust patient follow-up .

Detailed description

It is a prospective, exploratory, randomised, multi-centre, open, controlled study with a 1:1 ratio of two parallel groups, with obstructive sleep apnoea patients starting CPAP/APAP therapy, and receiving by the homecare provider, either an individualised treatment plan (VitalCare) or national standard of care. This study will be conducted in 5 hospital centres in Portugal.. During a regular medical consultation, eligible patients who have signed their informed consent will be randomised by their investigator. Two study groups will be set up: 1. Standard of care group 2. VitalCare group Two medical visits in the hospital centres will be scheduled in the context of the study for all participating patients: 1. A screening/inclusion visit before CPAP/APAP initiation at home; 2. An end-of-study visit planned at 12 months (± 1 month) after CPAP/APAP initiation at home. All visits done in the hospital centres at the discretion of the investigators between patient's screening/inclusion visit and end-of-study visit will be recorded in the eCRF with the reason for the visit and change in CPAP/APAP prescription, if applicable The primary objective of this study is to evaluate adherence to CPAP/APAP treatment at 3 months in patients with individualised treatment plan (VitalCare) compared to patients with standard of care

Conditions

• Obstructive Sleep Apnoea Syndrome (OSAS)

Interventions

Type	Name	Description
OTHER	individualised treatment plan (VitalCare) and associated remote medical monitoring	VitalCare is a treatment plan to help in the personalisation of patient care.

Timeline

• Start date: 2022-02-15
• Primary completion: 2023-02-15
• Completion: 2024-06-30
• First posted: 2022-02-18
• Last updated: 2025-09-10

Locations

1 site across 1 country: Portugal