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

Summary

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

• Atrial Fibrillation
• Obstructive Sleep Apnea

Interventions

DEVICE

(Cardio)Respiratory polygraphy (NOX T3s)

This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).

DIAGNOSTIC_TEST

Polysomnography

Polysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic.

DEVICE

Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)

Devices can be used to deliver CPAP, BiPAP, or ASV treatment to open up the airways, making breathing during sleep possible.

DEVICE

Fitbit smartwatch

The smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.

Sponsors & Collaborators

• Jessa Hospital

  collaborator OTHER

• Hasselt University

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• University Hospital, Antwerp

  lead OTHER

Principal Investigators

• Hein Heidbuchel, MD, PhD · University Hospital of Antwerp

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-23

Primary Completion

2028-02-29

Completion

2028-02-29

Countries

• Belgium

Study Locations