RecruitingNot ApplicableNCT06263608

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


Sponsor

University Hospital, Antwerp

Enrollment

209 participants

Start Date

Feb 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether screening and treating sleep apnea in patients with atrial fibrillation (an irregular heartbeat) can improve heart rhythm and overall outcomes. **You may be eligible if...** - You have been diagnosed with paroxysmal or persistent atrial fibrillation (AF) confirmed by an ECG - You experience symptoms from your irregular heartbeat - You are older than 18 years - You own a smartphone compatible with Fitbit and FibriCheck apps **You may NOT be eligible if...** - You have permanent atrial fibrillation or only atrial flutter - You have already been tested or treated for sleep apnea (e.g., using a CPAP machine) - You have significant memory or thinking problems - You are unable to speak or fully understand Dutch - Your heart rhythm depends on a pacemaker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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_TESTPolysomnography

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

DEVICEDevices 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.

DEVICEFitbit 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

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NCT06263608


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