STAROSA Trial - Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- AF burden before and after CPAP treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: (Cardio)Respiratory polygraphy (NOX T3s) (Device)
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).
干预措施: Polysomnography (Diagnostic Test)
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).
干预措施: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) (Device)
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).
干预措施: Fitbit smartwatch (Device)
结局指标
主要结局
AF burden before and after CPAP treatment
时间窗: 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.
次要结局
- False positive rate of polygraphy(Result known after polysomnography examination, on average 6 weeks after the polysomnography examination)
- Obstructive sleep apnea severity agreement between polygraphy and polysomnography(Result known after polysomnography examination, on average 6 weeks after the polysomnography examination)
- Total sleep apnea burden(On average 3 months after initiation of obstructive sleep apnea treatment)
- CPAP/BiPAP/ASV compliance(On average 3 months after initiation of obstructive sleep apnea treatment)
- Sleep score(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)(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)(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)(Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment)
- Polygraphy negative patients(24 hours after the one-time use of the polygraphy device)
- Obstructive sleep apnea severity agreement between polygraphy and polysomnography(Result known after polysomnography examination, on average 6 weeks after the polysomnography examination)
- False positive rate of polygraphy(Result known after polysomnography examination, on average 6 weeks after the polysomnography examination)
- Total sleep apnea burden(On average 3 months after initiation of obstructive sleep apnea treatment)
- CPAP/BiPAP/ASV compliance(On average 3 months after initiation of obstructive sleep apnea treatment)
- Sleep score(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)(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)(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)(Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment)
- Polygraphy negative patients(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(Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment)