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Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
Sponsor: University Hospital, Antwerp
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.
Official title: STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
209
Start Date
2024-02-23
Completion Date
2028-02
Last Updated
2025-09-15
Healthy Volunteers
No
Interventions
(Cardio)Respiratory polygraphy (NOX T3s)
This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).
Polysomnography
Polysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic.
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.
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