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

NCT05246449 | Completed

• 1 other identifier: ALMED-21-001
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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 .

Conditions

Obstructive Sleep Apnoea Syndrome (OSAS)

Keywords

CPAP/APAP; VitalCare; homecare provider; individualised treatment plan

Outcome Measures

Primary Outcomes (1)

• CPAP/APAP adherence evaluation

  average daily number of hours of CPAP/APAP use at 3 months

  3rd month

Secondary Outcomes (8)

• 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

• daytime sleepiness

  1st, 3rd, 6th,12th months

• Snoring and Quality of Life

  1st, 3rd, 6th,12th months

• For patients in the VitalCare group, Balachandran CPAP perception questionnaire

  1st, 3rd, 6th,12th months

Study Arms (2)

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.

Other: individualised treatment plan (VitalCare) and associated remote medical monitoring

Interventions

individualised treatment plan (VitalCare) and associated remote medical monitoring OTHER

VitalCare is a treatment plan to help in the personalisation of patient care.

VitalCare group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Liquide Santé International: lead
• Clinact: collaborator

Study Sites (1)

Hospital Distrital de Santarém

Santarém, Portugal

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 18, 2022
• Study Start: February 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: June 30, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

PT (1)