Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation, Obstructive Sleep Apnea
In brief
The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population. Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction, symptom burden and alcohol consumption questionnaires twice: right after the polysomnography examination and after the 3-month treatment.
Key facts
- Study ID
- NCT06263608
- Run by
- University Hospital, Antwerp
- People needed
- 209
- Starts
- 2024-02-23
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- University Hospital of Antwerp — Edegem, Belgium (enrolling)
- Jessa Hospital — Hasselt, Belgium (enrolling)
Full record on ClinicalTrials.gov
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