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

Air Liquide

Status: Completed

Conditions: Obstructive Sleep Apnoea Syndrome (OSAS)

Treatments: Other: individualised treatment plan (VitalCare) and associated remote medical monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05246449

ALMED-21-001

Details and patient eligibility

About

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 .

Full 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

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

113 participants in 2 patient groups

Standard of care group

No Intervention group

Description:

with patients starting their regular CPAP/APAP treatment without stratification, with medical follow-up, and with standard home CPAP/APAP service provided by home healthcare,

VitalCare group

Experimental group

Description:

with patients starting their CPAP/APAP treatment and with a personalized follow-up by the homecare provider.

Treatment:

Other: individualised treatment plan (VitalCare) and associated remote medical monitoring