Obstructive Sleep Apnoea Syndrome (OSAS)VitalCareNCT05246449
Evaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP
A study testing individualised treatment plan (VitalCare) and associated remote medical monitoring in people with Obstructive Sleep Apnoea Syndrome (OSAS), run by Air Liquide Santé International at 1 site in Portugal.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnoea Syndrome (OSAS)
- What is being tested?
- individualised treatment plan (VitalCare) and associated remote medical monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Feb 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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 .
Read the 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:
- Standard of care group
- VitalCare group
Two medical visits in the hospital centres will be scheduled in the context of the study for all participating patients:
- A screening/inclusion visit before CPAP/APAP initiation at home;
- 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)
- Being tested
- individualised treatment plan (VitalCare) and associated remote medical monitoring
- Keywords
- CPAP/APAP, VitalCare, homecare provider, individualised treatment plan
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualised treatment plan (VitalCare) and associated remote medical monitoringOther
VitalCare is a treatment plan to help in the personalisation of patient care.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group | No intervention | 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 | with patients starting their CPAP/APAP treatment and with a personalized follow-up by the homecare provider. Receives: Other: individualised treatment plan (VitalCare) and associated remote medical monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP/APAP adherence evaluation
average daily number of hours of CPAP/APAP use at 3 months
Measured: 3rd month
Secondary outcomes (8)
adherence to CPAP/APAP
daily average duration of CPAP/APAP use
Measured: 1st, 6th,12th months
evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices
Daily Apnoea-Hypopnoea Index (AHI) expressed in average daily number per hour and daily non intentional leaks level expressed in L/min as both median and 95th percentile
Measured: 1st, 3rd, 6th,12th months
daytime sleepiness
The numerical answers obtained for the 8 common daily life situations of the Epworth Sleepiness Scale (ESS) are added to calculate the ESS score each time it is collected
Measured: 1st, 3rd, 6th,12th months
Snoring and Quality of Life
The numerical answers obtained for the 5 questions of the snoring questionnaire are added to calculate the snoring score each time the questionnaire is collected. The numerical answer from 0 to 10 obtained on the Quality of Life visual analogue scale is used each time the questionnaire is collected.
Measured: 1st, 3rd, 6th,12th months
For patients in the VitalCare group, Balachandran CPAP perception questionnaire
The numerical answers obtained for the 4 questions regarding difficulty tolerating CPAP, discomfort with CPAP pressure, likelihood of wearing CPAP, and perceived health benefit are added to calculate the CPAP perception score each time it is collected.
Measured: 1st, 3rd, 6th,12th months
Number of contacts between home healthcare provider and patient
The data files extracted from the home healthcare provider database will allow to count for each study patient, the number of contacts between the home healthcare provider and the patient either i) at home, ii) remotely or iii) in care centres
Measured: 1st, 3rd, 6th,12th months
For patients in the VitalCare group, number of updates of the individualised treatment plan
The data files extracted from the home healthcare provider database will allow to count for each patient from the VitalCare group, the number of updates of the individualised treatment plan
Measured: 1st, 3rd, 6th,12th months
adverse events description
all adverse events recorded by investigators in the eCRF
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start15 Feb 2022
- Primary completion15 Feb 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnoea Syndrome (OSAS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246449
- Sponsor's protocol ID
- ALMED-21-001
- Acronym
- VitalCare
- Status last verified
- Sep 2025
- First submitted
- 27 Jan 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05246449
- Acronym / sponsor ID
- VitalCare / ALMED-21-001
- Conditions
- Obstructive Sleep Apnoea Syndrome (OSAS)
- Keywords
- CPAP/APAP, VitalCare, homecare provider, individualised treatment plan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Standard of care group
- VitalCare group
Two medical visits in the hospital centres will be scheduled in the context of the study for all participating patients:
- A screening/inclusion visit before CPAP/APAP initiation at home;
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care group | No intervention | –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 | Other: individualised treatment plan (VitalCare) and associated remote medical monitoringwith patients starting their CPAP/APAP treatment and with a personalized follow-up by the homecare provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individualised treatment plan (VitalCare) and associated remote medical monitoringVitalCare is a treatment plan to help in the personalisation of patient care. | Other | VitalCare group |
Primary outcome
CPAP/APAP adherence evaluation
Time frame: 3rd month
average daily number of hours of CPAP/APAP use at 3 months
8 secondary outcomes
adherence to CPAP/APAP
Time frame: 1st, 6th,12th months
evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices
Time frame: 1st, 3rd, 6th,12th months
daytime sleepiness
Time frame: 1st, 3rd, 6th,12th months
Snoring and Quality of Life
Time frame: 1st, 3rd, 6th,12th months
For patients in the VitalCare group, Balachandran CPAP perception questionnaire
Time frame: 1st, 3rd, 6th,12th months
Number of contacts between home healthcare provider and patient
Time frame: 1st, 3rd, 6th,12th months
For patients in the VitalCare group, number of updates of the individualised treatment plan
Time frame: 1st, 3rd, 6th,12th months
adverse events description
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individualised treatment plan (VitalCare) and associated remote medical monitoring in people with Obstructive Sleep Apnoea Syndrome (OSAS), run by Air Liquide Santé International at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP/APAP adherence evaluation (time frame: 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.