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Идёт набор NCT07427589

Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea

— Наблюдательное Obstructive Sleep Apnea Cardiovascular (CV) Risk

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: Continuous positive airway pressure, Mandibular advancement device, Hypoglossal nerve stimulation.
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea, Cardiovascular (CV) Risk. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this prospective study is to gain insight into the endophenotypic variation in OSA, with a focus on the underlying pathophysiological traits and the cardiovascular alterations associated with the condition. To capture the variability in OSA endophenotypes, novel metrics that extend beyond the AHI will be considered, with particular attention to the sleep-apnea-specific hypoxic burden, the sleep-apnea-specific heart rate response, and pulse wave amplitude drops (PWADs). Since the impact of treatment on cardiovascular parameters remains an important point of interest, the effects of different treatment modalities on cardiovascular changes will be investigated, including continuous positive airway pressure (CPAP), mandibular advancement devices (MADs), and hypoglossal nerve stimulation.

Вмешательства

  • Устройство Continuous positive airway pressure
    CPAP remains the most commonly used treatment modality and is considered as the gold standard for patients with OSA because of its high efficacy and noninvasive nature. CPAP therapy is indicated for patients with moderate to severe OSA (AHI ≥ 15/h) or for those with a lower AHI with symptoms of excessive daytime sleepiness. It is effective in reducing nocturnal obstructive events by delivering continuous positive airway pressure, which functions as a pneumatic splint to keep the upper airway ope
  • Устройство Mandibular advancement device
    Mandibular advancement device (MAD) has become a widely recognized non-invasive treatment alternative for patients who cannot tolerate CPAP. It is primarily indicated for mild to moderate OSA and lately also for severe OSA patients. These MADs are worn intraorally during the night and attach to both upper and lower dental arches, protrude the lower jaw to widen and reopen the upper airway.
  • Устройство Hypoglossal nerve stimulation
    Hypoglossal nerve stimulation (HNS) is a novel and unique therapeutic option for patients with moderate-to-severe OSA who cannot be treated effectively with CPAP or MAD. In contrast to traditional reconstructive procedures for OSA, which focus only on anatomical adjustments, HNS integrates a surgical implantation process with an adjustable medical device to open the upper airway through neuromodulation of the hypoglossal nerve.

Первичные конечные точки

  • Cardiovascular outcome: interventricular septum thickness [Срок оценки: 1 year]
Вторичные конечные точки (12)
  • Sleep apnea-specific hypoxic burden (SASHB) [Срок оценки: 1 year]
  • Heart rate response to a respiratory event (ΔHR) [Срок оценки: 1 year]
  • Pulse wave amplitude drops (PWADs) [Срок оценки: 1 year]
  • Cardiovascular outcome: heart rate variability [Срок оценки: 1 year]
  • Cardiovascular outcome: left ventricular ejection fraction [Срок оценки: 1 year]
  • Cardiovascular outcome: left ventricular mass [Срок оценки: 1 year]
  • Cardiovascular outcome: 24-hour ambulatory blood pressure [Срок оценки: 1 year]
  • Cardiovascular outcome: systolic and diastolic function [Срок оценки: 1 year]
  • OSA efficacy: delta apnea-hypopnea index (AHI) [Срок оценки: 1 year]
  • Oxygen desaturation index (ODI) [Срок оценки: 1 year]
  • Therapy adherence defined by the amount of hours of therapy usage per night and the number of nights per week of use [Срок оценки: 1 year]
  • Degree of snoring measured by Visual Analogue Scale (VAS) [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • AHI ≥ 15 events/hour, based on a recent (<2 years) PSG, conducted in Antwerp University Hospital
  • Patients must be 18 years or older
  • Patients must be dutch-speaking
  • Patients must be eligible for their therapy (CPAP, MAD or HNS)
  • Willing to participate after informed consent

Критерии исключения

  • Central apneas accounting for ≥25% of total apneas during baseline polysomnography
  • Patients who have received effective CPAP therapy (defined as CPAP use for ≥4 h/night) within the previous 6 months
  • Patients with prior MAD therapy
  • Uncontrolled hypertension
  • Known cardiomyopathy
  • Significant coronary arterial disease
  • Clinically significant valvular heart disease, defined as more than mild left-sided valvular disease or more than moderate right-sided valvular disease
  • Congenital heart disease
  • Participants may be excluded if, after rescoring, outcome measures do not meet predefined criteria

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 1 центр
  • Antwerp University Hospital — Antwerp

Идентификаторы

NCT: NCT07427589 · 4699 · G063725N

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗