Status:
COMPLETED
Evaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP
Lead Sponsor:
Air Liquide Santé International
Collaborating Sponsors:
Clinact
Conditions:
Obstructive Sleep Apnoea Syndrome (OSAS)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 treatme...
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 recei...
Eligibility Criteria
Inclusion
- Patient diagnosed with Obstructive Sleep Apnoea Syndrome (OSAS) who is newly prescribed CPAP or APAP therapy at inclusion
- Patient agreeing to the collection of data from their CPAP/APAP device via teletransmission
- Patient equipped with a device compatible with the ResMed telemonitoring data platform
- Patient who has signed the informed consent form for the study
Exclusion
- Obese patient presenting hypoventilation
- Patient at risk of other sleep disorders (e.g. severe insomnia)
- Patient with physical, mental or cognitive inability to use all components of the remote medical monitoring project and individualised treatment plan, as determined by the investigator wishing to include the patient
- Patient with severe COPD (FEV1 ≤ 50% predicted or modified Medical Research Council (mMRC) dyspnoea scale \> 2)
- Patient with severe Chronic Heart Failure (NYHA stage III or IV)
- Patient's refusal of CPAP/APAP treatment support
- Previous CPAP/APAP treatment for Sleep Apnoea
- Patient with ongoing Mandibular Advancement Device (MAD) or in the 12 previous months
- Patient with no permanent place of residence
- Patient participating in another drug or device study within the previous 30 days
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT05246449
Start Date
February 15 2022
End Date
June 30 2024
Last Update
September 10 2025
Active Locations (1)
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1
Hospital Distrital de Santarém
Santarém, Portugal