Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
NCT ID: NCT06263608
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
209 participants
INTERVENTIONAL
2024-02-23
2028-02-29
Brief Summary
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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.
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Detailed Description
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Despite the high prevalence of obstructive sleep apnea in AF patients (about 62%), it often goes underrecognized and underdiagnosed. Lack of symptom reporting and easily accessible screening tools and strategies contribute to this underdiagnosis. The standard diagnostic method is through polysomnography, which, while effective, has drawbacks such as high costs, labor intensity, and time-consuming nature, making it challenging to use as a screening tool. (Cardio)respiratory polygraphy devices, such as the NOX-T3s, are gaining interest for obstructive sleep apnea detection due to their user-friendly nature, comfort, convenience, and home useability. A previous validation study showed that the NOX-T3s polygraphy device had high accuracy, sensitivity, and specificity and was also the most user-friendly for obstructive sleep apnea detection in AF patients.
Besides the screening, retrospective research has shown that obstructive sleep apnea treatment with the gold standard method, continuous positive airway pressure (CPAP), positively influences AF recurrence through improved antiarrhythmic therapy. Current literature suggests early obstructive sleep apnea diagnosis, followed by early CPAP treatment, could reduce AF recurrence. However, prospective studies supporting this are lacking. Therefore, additional information on the heart rhythm of AF patients, monitored in a (semi)-continuous manner before and after treatment initiation, would be valuable to investigate if treatment (mostly CPAP) leads to a reduction in AF events.
However, implementing a care pathway using the NOX T3s for structured obstructive sleep apnea testing and the Fitbit Versa smartwatch with the FibriCheck algorithm for the follow-up of AF recurrence in standard clinical care in an AF population still needs to be evaluated.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Symptomatic AF patients
Eligible participants will use the NOX T3s polygraphy device for one night at home. If they have a positive obstructive sleep apnea diagnosis, they will be referred to a polysomnography examination, and subsequently treatment. Participants will also receive 3 to 6 months of semi-continuous heart rhythm monitoring with the Fitbit smartwatch (depending on whether they get treatment after obstructive sleep apnea diagnosis via polysomnography).
(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.
Interventions
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(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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior/recent polysomnography evaluation
* Prior/active CPAP/BiPAP/ASV treatment
* Cognitive impairment
* Inability to speak or fully understand Dutch
* Pacemaker-dependent heart rhythm
18 Years
ALL
No
Sponsors
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Jessa Hospital
OTHER
Hasselt University
OTHER
Universiteit Antwerpen
OTHER
University Hospital, Antwerp
OTHER
Responsible Party
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Principal Investigators
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Hein Heidbuchel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Antwerp
Locations
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University Hospital of Antwerp
Edegem, , Belgium
Jessa Hospital
Hasselt, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BUN B3002023000204
Identifier Type: -
Identifier Source: org_study_id
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