Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
- Conditions
- Atrial FibrillationObstructive Sleep Apnea
- Interventions
- Device: (Cardio)Respiratory polygraphy (NOX T3s)Diagnostic Test: PolysomnographyDevice: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV)Device: Fitbit smartwatch
- Registration Number
- NCT06263608
- Lead Sponsor
- University Hospital, Antwerp
- Brief 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 and symptom burden 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 209
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Symptomatic AF patients Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) 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). Symptomatic AF patients Polysomnography 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). Symptomatic AF patients Fitbit smartwatch 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). Symptomatic AF patients (Cardio)Respiratory polygraphy (NOX T3s) 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).
- Primary Outcome Measures
Name Time Method AF burden before and after CPAP treatment During the entire duration of the study (2 periods of 3 months) The AF burden will be measured via semi-continuous FibriCheck measurements via a Fitbit smartwatch.
- Secondary Outcome Measures
Name Time Method Total sleep apnea burden On average 3 months after initiation of obstructive sleep apnea treatment The total sleep apnea burden will be measured by the CPAP/BiPAP/ASV device
Obstructive sleep apnea severity agreement between polygraphy and polysomnography Result known after polysomnography examination, on average 6 weeks after the polysomnography examination The obstructive sleep apnea severity agreement between the NOX T3s polygraphy device and the in-hospital polysomnography examination will be assessed by evaluating AHI values.
Sleep score 3 months after first and after second period of semi-continuous monitoring with Fitbit smartwatch The sleep score will be determined based on Fitbit data. The score is based on sleep duration, sleep quality, and restoration. The minimum value is 0 and the maximum value is 100. The higher the value, the better the overall sleep efficiency.
False positive rate of polygraphy Result known after polysomnography examination, on average 6 weeks after the polysomnography examination The false positive rate will be calculated using a polygraphy apnea-hypopnea index value for referral to the sleep clinic compared to polysomnography
CPAP/BiPAP/ASV compliance On average 3 months after initiation of obstructive sleep apnea treatment CPAP/BiPAP/ASV compliance will be read out from the device.
Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ) Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment The Leuven ARrhythmia Questionnaire (LARQ) will be used to assess the AF symptom profile based on six symptoms: palpitations, dyspnea, chest pain, syncope, dizziness, and fatigue. The minimum score is 0 and maximum score is 100. The higher the score, the more pronounced the symptom burden.(LARQ) before and after treatment.
Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ) Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment The Berlin Questionnaire (BQ) will be used to assess the risk of sleep apnea focusing on 3 OSA symptoms (snoring, daytime sleepiness, and obesity/hypertension). For the first two symptoms, the category is positive if 2 points or more are given. The last category is positive if the patient has obesity and/or hypertension.
Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS) Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment The Epworth Sleepiness Scale (ESS) will be used to assess the overall daytime sleepiness in eight situations. Minimum score is 0 and the maximum score is 24. The higher the score, the higher the chance for daytime sleepiness.
Polygraphy negative patients 24 hours after the one-time use of the polygraphy device The number of polygraphy-negative patients in a general AF population will be calculated.
Trial Locations
- Locations (2)
University Hospital of Antwerp
🇧🇪Edegem, Belgium
Jessa Hospital
🇧🇪Hasselt, Belgium