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
University Hospital, Antwerp
209 participants
Feb 23, 2024
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
Plain Language Summary
Simplified for easier understanding
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
This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).
Polysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic.
Devices can be used to deliver CPAP, BiPAP, or ASV treatment to open up the airways, making breathing during sleep possible.
The smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.
Locations(2)
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NCT06263608