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Personalized sleep apnea plan aims to boost CPAP compliance

NCT ID NCT05246449

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a personalized treatment plan called VitalCare for people with obstructive sleep apnea who were starting CPAP therapy. The plan included remote monitoring and tailored follow-up to help patients use their CPAP machine more regularly. Researchers enrolled 113 participants and measured how many hours per night they used CPAP after three months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
personalized treatment plan (VitalCare) with remote monitoring
What this could lead to
If it works, this could help people with sleep apnea stick with their CPAP therapy, leading to better sleep and health.
What could go wrong
This is a small, early exploratory study. The personalized plan may not improve CPAP use for everyone, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

113 people

The number who actually took part.

Started

Feb 2022

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Distrital de Santarém

    Santarém, Portugal