Testing and treating sleep apnea in patients with atrial fibrillation
STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
NA · University Hospital, Antwerp · NCT06263608
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 209 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp (other) |
| Locations | 2 sites (Edegem and 1 other locations) |
| Trial ID | NCT06263608 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with paroxysmal or persistent atrial fibrillation who experience symptoms and own a compatible smartphone.
Not a fit: Patients with permanent atrial fibrillation, cognitive impairments, or those currently undergoing CPAP treatment may not benefit from this study.
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 performed: Previous studies have shown promising results using similar home-based polygraphy devices for diagnosing obstructive sleep apnea, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Edegem and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Obstructive Sleep Apnea, Atrial fibrillation, Obstructive sleep apnea, Cardiorespiratory polygraphy, Continuous positive airway pressure, Mobile health technology