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Can a sleep machine keep your heart in rhythm?

NCT ID NCT04519489

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at whether using a positive airway pressure (PAP) machine at night can reduce the return of atrial fibrillation (an irregular heartbeat) in people who also have obstructive sleep apnea. About 129 participants with both conditions were assigned to receive either standard heart care plus PAP therapy or standard care alone. The goal was to see if treating sleep apnea helps keep the heart in a normal rhythm after procedures like ablation or medication.

What this could mean

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

Active substance
Positive airway pressure (PAP) therapy device (Philips DreamStation) with telemonitoring (Philips EncoreAnywhere)
What this could lead to
If successful, this could show that treating sleep apnea with PAP therapy helps prevent atrial fibrillation from coming back after standard heart rhythm treatments.
What could go wrong
The study was terminated early, so results may be incomplete. It is also unclear how well patients will stick to nightly PAP therapy, which is crucial for effectiveness.

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

129 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2021

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 to 75 years

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: * Symptomatic paroxysmal or persistent atrial fibrillation: 1. Paroxysmal: at least having one episode every month for the last recent 6 months. Each episode with symptoms lasting for over 30 minutes and at least one episode is documented (≥30 seconds episode length, documented by ECG). 2. Persistent: lasting over 7 days to 1 year persistent AF with ECG documented. * Implement a rhythm control strategy, including: 1. Ablation and restored on sinus rhythm after the procedure. 2. Underwent medical or electrical cardioversion during hospitalization and restored on sinus rhythm before enrollment. * OSA diagnosed with PSG test showing AHI≥10; * 18 ≤ Age ≤ 75; * Willing to participate in the study; * Able to provide informed consent; * Having access to smartphones and the internet, and be capable of using them. Exclusion Criteria: * BMI \> 30 kg/m2; * LVEF ≤ 40% or HF with NYHA III/ IV; * Other atrial arrhythmias, atrial flatter; * Myocardial infarction; * Hypertrophic Cardiomyopathy (HCM); * Congenital heart disease; * A clear diagnosis with heart valve diseases (including moderate-severe mitral stenosis/ insufficiency, moderate-severe aortic stenosis/ insufficiency); * Hyperthyroidism heart disease; * Other acute diseases leading to temporary AF; * In surgery perioperative period; * Accepted other cardiothoracic surgery except for ablation; * PSG test showing mainly central apneas (Cheyne-Stokes breathing); * Pulmonary diseases causing dyspnea at rest or on minimal exertion; * With other active major organ system disease that is not suitable for study participation, such as cancer, severe liver diseases, severe kidney diseases, etc.; * With significantly impaired cognitive function, having severe problems in learning, memory, perception, and problem solving, and are unable to understand or not be competent to the informed consent; * Having already accepted treatment to the sleep apnea syndrome; * Having received intervention in any other trial within 30 days prior to the planned recruitment.

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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

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

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