Clinical trial NCT05246449: Evaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnoea Syndrome (OSAS)
Keywords: CPAP/APAP
VitalCare
homecare provider
individualised treatment plan
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: Clinact
First posted: 2022-02-18
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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

Eligibility criteria: 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

Primary outcomes:
measure: CPAP/APAP adherence evaluation
timeFrame: 3rd month
Secondary outcomes:
measure: adherence to CPAP/APAP
timeFrame: 1st, 6th,12th months
measure: evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices
timeFrame: 1st, 3rd, 6th,12th months
measure: daytime sleepiness
timeFrame: 1st, 3rd, 6th,12th months
measure: Snoring and Quality of Life
timeFrame: 1st, 3rd, 6th,12th months
measure: For patients in the VitalCare group, Balachandran CPAP perception questionnaire
timeFrame: 1st, 3rd, 6th,12th months
measure: Number of contacts between home healthcare provider and patient
timeFrame: 1st, 3rd, 6th,12th months
measure: For patients in the VitalCare group, number of updates of the individualised treatment plan
timeFrame: 1st, 3rd, 6th,12th months
measure: adverse events description
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Santarém
country: Portugal
facility: Hospital Distrital de Santarém
Study officials:
References: