Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06263608

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

Led by University Hospital, Antwerp · Updated on 2026-05-08

209

Participants Needed

2

Research Sites

205 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Antwerp

Lead Sponsor

J

Jessa Hospital

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with paroxysmal or persistent atrial fibrillation using a 12-lead ECG
  • Experience symptoms from atrial fibrillation with mEHRA score of 2a or higher
  • Age older than 18 years
  • Own a smartphone compatible with Fitbit and FibriCheck apps (recent Apple iOS or Android versions)
  • Able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed with permanent atrial fibrillation or only atrial flutter
  • Previous or recent polysomnography sleep study
  • Previous or ongoing treatment with CPAP, BiPAP, or ASV
  • Cognitive impairment
  • Unable to speak or fully understand Dutch
  • Heart rhythm depends on a pacemaker

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University Hospital of Antwerp

Edegem, Belgium

Actively Recruiting

2

Jessa Hospital

Hasselt, Belgium

Actively Recruiting

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Research Team

L

Lien Desteghe, MSc, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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