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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnoea Syndrome (OSAS)
- Sponsor
- Air Liquide Santé International
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- CPAP/APAP adherence evaluation
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
CPAP/APAP adherence evaluation
Time Frame: 3rd month
average daily number of hours of CPAP/APAP use at 3 months
Secondary Outcomes
- adherence to CPAP/APAP(1st, 6th,12th months)
- evolution of daily Apnoea-Hypopnoea Index (AHI) and Non intentional leaks level teletransmitted by CPAP/APAP devices(1st, 3rd, 6th,12th months)
- adverse events description(through study completion, an average of 1 year)
- daytime sleepiness(1st, 3rd, 6th,12th months)
- For patients in the VitalCare group, Balachandran CPAP perception questionnaire(1st, 3rd, 6th,12th months)
- Number of contacts between home healthcare provider and patient(1st, 3rd, 6th,12th months)
- For patients in the VitalCare group, number of updates of the individualised treatment plan(1st, 3rd, 6th,12th months)
- Snoring and Quality of Life(1st, 3rd, 6th,12th months)