Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Testing and treating sleep apnea in patients with atrial fibrillation

Official title: STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation

Run by University Hospital, Antwerp · NCT06263608 · Data updated 2026-11-12

This study tests whether a new program for diagnosing and treating sleep apnea can help people with atrial fibrillation feel better and reduce their heart rhythm problems.

More Atrial Fibrillation trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment209 (estimated)
SponsorUniversity Hospital, Antwerp
Academic / other
Locations2 sites (Edegem and 1 other locations)
StatusRecruiting
StartedFebruary 23, 2024
Main results expectedFebruary 2028
Study endsFebruary 2028
Registry record updatedMay 8, 2026
Trial IDNCT06263608 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 diagnosed with paroxysmal or persistent atrial fibrillation who experience symptoms and own a compatible smartphone.

Probably not a fit

Patients with permanent atrial fibrillation, cognitive impairments, or those currently undergoing CPAP treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of a structured testing and treatment program for obstructive sleep apnea in patients diagnosed with atrial fibrillation. Participants will use the NOX T3s device for home-based respiratory polygraphy, and those diagnosed with obstructive sleep apnea will undergo further evaluation and treatment, primarily using continuous positive airway pressure (CPAP). The study also incorporates the use of a Fitbit smartwatch to monitor patients over a six-month period, assessing their symptoms and satisfaction with the treatment. The goal is to improve the recognition and management of obstructive sleep apnea in this population, potentially reducing atrial fibrillation recurrence.

Why it matters

Potential benefit: If successful, this approach could lead to better management of obstructive sleep apnea in atrial fibrillation patients, potentially reducing the frequency of AF episodes.

How similar studies have gone: Previous studies have shown promising results using similar home-based polygraphy devices for diagnosing obstructive sleep apnea, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients in whom AF (paroxysmal or persistent) is diagnosed with a 12-lead ECG
* Patients who experience symptoms of their AF (mEHRA ≥ 2a)
* Older than 18 years
* Owning a smartphone compatible with Fitbit and FibriCheck applications (i.e. recent versions of Apple iOS or Android drivers)
* Ability to sign the informed consent

Exclusion Criteria:

* Patients diagnosed with permanent AF or only atrial flutter
* Prior/recent polysomnography evaluation
* Prior/active CPAP/BiPAP/ASV treatment
* Cognitive impairment
* Inability to speak or fully understand Dutch
* Pacemaker-dependent heart rhythm

Where it's running

  • University Hospital of Antwerp
    Edegem, Belgium
    Recruiting
  • Jessa Hospital
    Hasselt, Belgium
    Recruiting

Study contacts

  • Principal investigator: Hein Heidbuchel, MD, PhD — University Hospital of Antwerp
  • Study coordinator: Lien Desteghe, MSc, PhD
  • Email: lien.desteghe@uza.be
  • Phone: +32 3 821 33 06

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.