Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation

Recruiting · NCT06263608 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Antwerp

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Atrial Fibrillation

Interventions studied

(Cardio)Respiratory polygraphy (NOX T3s)Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)Fitbit smartwatchPolysomnography

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 is running

2 locations listed.

University Hospital of Antwerp - Edegem, Belgium
Jessa Hospital - Hasselt, Belgium

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →