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Идёт набор NCT06263608

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

Без фазы С лечением Atrial Fibrillation Obstructive Sleep Apnea

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: (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.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation, Obstructive Sleep Apnea. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство (Cardio)Respiratory polygraphy (NOX T3s)
    This home-based device enables the detection of obstructive sleep apnea by calculating the apnea hypopnea index (AHI).
  • Диагностический тест Polysomnography
    Polysomnography allows both sleep and respiration monitoring during an overnight stay in a dedicated sleep clinic.
  • Устройство 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.
  • Устройство Fitbit smartwatch
    The smartwatch enables the semi-continuous monitoring of the heart rhythm via the installed FibriCheck algorithm.

Первичные конечные точки

  • AF burden before and after CPAP treatment [Срок оценки: During the entire duration of the study (2 periods of 3 months)]
Вторичные конечные точки (10)
  • Obstructive sleep apnea severity agreement between polygraphy and polysomnography [Срок оценки: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination]
  • False positive rate of polygraphy [Срок оценки: Result known after polysomnography examination, on average 6 weeks after the polysomnography examination]
  • Total sleep apnea burden [Срок оценки: On average 3 months after initiation of obstructive sleep apnea treatment]
  • CPAP/BiPAP/ASV compliance [Срок оценки: On average 3 months after initiation of obstructive sleep apnea treatment]
  • Sleep score [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment]
  • Polygraphy negative patients [Срок оценки: 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 [Срок оценки: Right after the polysomnography examination and 3 months after obstructive sleep apnea treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Бельгия · 2 центра
  • University Hospital of Antwerp — Edegem
  • Jessa Hospital — Hasselt

Идентификаторы

NCT: NCT06263608 · BUN B3002023000204

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗