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Recruiting NCT06263608

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

No phase Interventional Atrial Fibrillation Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: (Cardio)Respiratory polygraphy (NOX T3s), Polysomnography, Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV), Fitbit smartwatch.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

Atrial fibrillation (AF) is the most prevalent arrhythmia globally. Research has shown that AF is associated with various risk factors such as hypertension, diabetes, obesity, and obstructive sleep apnea. Obstructive sleep apnea is a sleep-disordered breathing condition that is highly prevalent in AF patients, contributing to the development and progression of AF.

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.

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 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.

Primary outcome measures

  • AF burden before and after CPAP treatment [Time frame: During the entire duration of the study (2 periods of 3 months)]
Secondary outcome measures (10)
  • Obstructive sleep apnea severity agreement between polygraphy and polysomnography [Time frame: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination]
  • False positive rate of polygraphy [Time frame: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination]
  • Total sleep apnea burden [Time frame: On average 3 months after initiation of obstructive sleep apnea treatment]
  • CPAP/BiPAP/ASV compliance [Time frame: On average 3 months after initiation of obstructive sleep apnea treatment]
  • Sleep score [Time frame: 3 months after first and after second period of semi-continuous monitoring with Fitbit smartwatch]
  • Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ) [Time frame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment]
  • Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ) [Time frame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment]
  • Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS) [Time frame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment]
  • Polygraphy negative patients [Time frame: 24 hours after the one-time use of the polygraphy device]
  • Patients' alcohol consumption assessed by the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) supplemented with four additional questions related to alcohol consumption [Time frame: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 2 centers
  • University Hospital of Antwerp — Edegem
  • Jessa Hospital — Hasselt

Identifiers

NCT: NCT06263608 · BUN B3002023000204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗