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Pacemaker algorithm could spot sleep apnea without extra tests

NCT ID NCT02751021

Diagnosis Sponsor: University Hospital, Caen 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special algorithm in a pacemaker can accurately diagnose sleep apnea in people with heart problems. Researchers compared the pacemaker's readings to a standard overnight sleep test in 66 participants. They also looked for a link between sleep apnea severity and a hormone called aldosterone.

What this could mean

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

What this could lead to
If successful, this could offer a simpler, more accessible way to diagnose sleep apnea in people with pacemakers, without needing a separate sleep study.
What could go wrong
This is a small, completed study with only 66 participants, so results may not apply to everyone. The algorithm may not be as accurate as standard tests.

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

66 people

The number who actually took part.

Started

Jun 2016

Finished

Jun 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * indication for permanent cardiac pacing (third degree atrioventricular block, second degree atrioventricular block mobitz 2 type, symptomatic sinus node dysfunction including brady-tachy form of sick sinus syndrome or bradyarrhythmia) * Diastolic dysfunction diagnosed at the transthoracic echocardiography Exclusion Criteria: * younger than 18 years old * lack of informed consent form * impossibility to fit in the scheduled study plan * indication for cardiac resynchronization or left ventricular ejection fraction lower than 45% * indication for epicardial pacemaker, known severe sleep apnea treated by continuous positive airway pressure

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease hyperaldosteronism obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Arrhythmias, cardiac Cardiac diastolic function Hyperaldosteronism Sleep apnea

Contacts and locations

Locations

  • Caen University Hospital

    Caen, Normandy, 14000, France

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