About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Patients diagnosed with permanent AF or only atrial flutter
Prior/recent polysomnography evaluation
Prior/active CPAP/BiPAP/ASV treatment
Cognitive impairment
Trial design
Treatments tested in this trial
- (Cardio)Respiratory polygraphy (NOX T3s)
- Polysomnography
- Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)
- Fitbit smartwatch
Treatment groups
Sponsors and collaborators
University Hospital, Antwerp
Lead sponsor
Jessa Hospital
Collaborator
Hasselt University
Collaborator
Universiteit Antwerpen
Collaborator