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

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 .

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnoea Syndrome (OSAS)
• Intervention / Treatment: Other: individualised treatment plan (VitalCare) and associated remote medical monitoring

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

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan-Fernando Ramirez; Phone Number: +33 (0)1 39 07 63 42; Email: fralsi-ctpublication@airliquide.com

Study Locations

• Portugal
  • Santarém, Portugal
    • Recruiting
    • Hospital Distrital de Santarém
    • Contact: Gustavo REIS, Dr; Phone Number: 938878010; Email: coimbrareis@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care group; 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,
Experimental: VitalCare group; with patients starting their CPAP/APAP treatment and with a personalized follow-up by the homecare provider.	Other: individualised treatment plan (VitalCare) and associated remote medical monitoring; VitalCare is a treatment plan to help in the personalisation of patient care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP/APAP adherence evaluation	average daily number of hours of CPAP/APAP use at 3 months	3rd month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adherence to CPAP/APAP	daily average duration of CPAP/APAP use	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	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	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.	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.	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	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	1st, 3rd, 6th,12th months
adverse events description	all adverse events recorded by investigators in the eCRF	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Air Liquide Santé International
• Collaborators: Clinact

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: CPAP/APAP; VitalCare; homecare provider; individualised treatment plan
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: ALMED-21-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No