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Real-world evaluation of the clinical performance and safety of apneal dx for the screening and aid in the diagnosis of obstructive sleep apnea-hypopnea syndrome in adults: a post-market clinical follow-up study

NCT ID NCT07809633

NEW Sponsor: Mitral Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 09, 2026

Summary

Sleep apnea-hypopnea syndrome (SAHS) is a frequent and largely under-diagnosed sleep-related breathing disorder. Adult prevalence is estimated between 9% and 38%. Untreated SAHS increases cardiometabolic and neurocognitive risk. Reference diagnostic methods (in-lab polysomnography and ambulatory ventilatory polygraphy) have limited capacity, which delays care. Apneal Dx is a Class IIa software as a medical device (CE-marked 10 June 2026). It measures cardiorespiratory sleep activity using the sensors of a standard smartphone worn on the chest, with no additional sensor, to screen for and aid in the diagnosis of adult obstructive sleep apnea-hypopnea syndrome at home. This study is a non-interventional, prospective, real-world post-market clinical follow-up (PMCF) of Apneal Dx used within its intended purpose in routine care. It does not add any examination, visit, randomisation or change to patient management. Data are collected from automatic device logs and optional in-app questionnaires completed by patients and healthcare professionals. The study covers France, Spain, Italy, the United Kingdom and Germany. There is no investigational site and no principal investigator.

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.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

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.

Who is studied

Adults with sleep complaints using the CE-marked Apneal Dx software as a medical device within its intended purpose, at home and in routine clinical practice, in France, Spain, Italy, Great Britain and Germany. The entire eligible active user base is solicited; no selection, sampling, stratification or quota is applied.

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: * Aged 18 years or over * Uses Apneal Dx within its intended purpose in France, Spain, Italy, the United Kingdom or Germany * Has completed at least one recording generating a night report * Has received the study information notice * Has given the in-app agreement to take part Exclusion Criteria: * Under 18 years of age * Adult under legal protection Both exclusion criteria are applied by design through an application eligibility rule.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Obstructive sleep apnea Sleep apnea syndromes Sleep apnea, obstructive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mitral SAS

    Charenton-le-Pont, 94220, France

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