Идёт набор NCT07555119

Night-to-Night Variability of Novel Physiological Parameters in Home Sleep Apnea Testing

— Наблюдательное Obstructive Apnea Diagnostic Sleep Apnea Syndrome (OSAS)

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Obstructive Apnea, Diagnostic, Sleep Apnea Syndrome (OSAS). 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: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Obstructive sleep apnea (OSA) is usually diagnosed from a single night of home sleep apnea testing using the apnea-hypopnea index (AHI). However, the AHI varies substantially from night to night, undermining diagnostic accuracy, and shows only modest correlation with symptoms. This variability further limits its usefulness for predicting cardiovascular and other complications. Besides the traditional AHI, more robust physiological markers are needed. Several emerging physiological metrics - hypoxic burden, ventilatory burden, heart rate variability, autonomic arousals, and the pulse wave amplitude drop index - capture the physiological impact of OSA more comprehensively and demonstrate stronger associations with cardiovascular risk. Despite this promise, their night-to-night variability has not been studied. A systematic evaluation of both established and novel OSA metrics across nights is essential to identify reliable, stable parameters suitable for clinical routine. This improves diagnostic precision beyond what traditional metrics can provide, enhances patient selection, reduces costs and patient harm, and may improve treatment outcomes.

Первичные конечные точки

Night-to-night variability of apnea-hypopnea index (events per hour of sleep) over 4 nights [Срок оценки: 4 nights of respiratory polygraphy]
Night-to-night variability of oxygen desaturation index (events per hour of sleep) over 10 nights [Срок оценки: 4 nights of respiratory polygraphy and 10 nights of oxymetry]
Night-to-night variability of hypoxic burden (minute x percent per hour of sleep) over 10 nights [Срок оценки: 4 nights of respiratory polygraphy and 10 nights of oxymetry]
Night-to-night variability of ventilatory burden over 4 nights [Срок оценки: 4 nights of respiratory polygraphy]
Night-to-night variability of heart rate variability over 10 nights [Срок оценки: 4 nights of respiratory polygraphy and 10 nights of oxymetry]
Night-to-night variability of pulse wave amplitude drops (events per hour) over 10 nights [Срок оценки: 4 nights of respiratory polygraphy and 10 nights of oxymetry]

Вторичные конечные точки (2)

Identification of factors contributing to and explaining variability [Срок оценки: 4 nights of respiratory polygraphy and 10 nights of oxymetry]
Correlation between physiological parameters from sleep testing and patient-reported outcome measures (PROMs) [Срок оценки: 4 nights of respiratory polygraphy and 10 nights of oxymetry]

Критерии участия

Критерии включения

Patients with suspected or diagnosed sleep-disordered breathing, irrespective of disease severity, as defined by the indications for home sleep apnea testing in the German guidelines \[15\]
No active treatment during sleep recordings or within preceding two weeks (e.g., mandibular advancement devices, positive airway pressure therapy)
Written informed consent obtained