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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

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

209 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Antwerp

Lead sponsor

Jessa Hospital

Collaborator

Hasselt University

Collaborator

Universiteit Antwerpen

Collaborator