Obstructive Sleep Apnoea Syndrome (OSAS)
Conditions
Keywords
CPAP/APAP, VitalCare, homecare provider, individualised treatment plan
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
Interventions
OTHERindividualised treatment plan (VitalCare) and associated remote medical monitoring
VitalCare is a treatment plan to help in the personalisation of patient care.
Sponsors
Clinact
Air Liquide Santé International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP/APAP adherence evaluation | 3rd month | average daily number of hours of CPAP/APAP use at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices | 1st, 3rd, 6th,12th months | 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 |
| daytime sleepiness | 1st, 3rd, 6th,12th months | 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 |
| Snoring and Quality of Life | 1st, 3rd, 6th,12th months | 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. |
| adherence to CPAP/APAP | 1st, 6th,12th months | daily average duration of CPAP/APAP use |
| Number of contacts between home healthcare provider and patient | 1st, 3rd, 6th,12th months | 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 |
| For patients in the VitalCare group, number of updates of the individualised treatment plan | 1st, 3rd, 6th,12th months | 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 |
| adverse events description | through study completion, an average of 1 year | all adverse events recorded by investigators in the eCRF |
| For patients in the VitalCare group, Balachandran CPAP perception questionnaire | 1st, 3rd, 6th,12th months | 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. |
Countries
Portugal
Outcome results
None listed