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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (2)

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