Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

Официальное название

A Single-center, Randomized, Open Label, Parallel Arm, Prospective Study to Evaluate the Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

Обзор

To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.

Подробное описание

Single-center, randomized, open label, parallel arm, prospective study in patients with sleep apnea after first-ever stroke.

The study will consist of screening, baseline assessment, interventional period (consisting of a treatment period and follow-up visits), and a follow-up phone call.

Patients will be randomly assigned to ASV (active) or control groups, within 4 days after the PSG II and will start the respective intervention in the same day.

Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated. Patients assigned to control group will receive best medical treatment for stroke alone, including rehabilitation.

Вмешательства

• Устройство Adaptive Servoventilation (ASV) therapy
  Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated
• Другое Best medical treatment
  Best medical treatment for stroke, including rehabilitation

Первичные конечные точки

• Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke. [Срок оценки: 1 month after stroke]

Вторичные конечные точки (8)

• Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) at 4 and 6 months after stroke. [Срок оценки: 4 and 6 months after stroke]
• Change from baseline in National Institutes of Health Stroke Scale (NIHSS) to measure improvement in neurological parameters at month 1, 4 and 6 after stroke. [Срок оценки: 1, 4 and 6 months after stroke]
• Type II full polysomnography (PSG II) within 7 days of stroke symptoms onset in all patients with AHI >5 as assessed by ApneaLink™ [Срок оценки: Within 7 days after admission]
• Adherence in the Servoventilation group [Срок оценки: After 1, 4 and 6 months]
• Efficacy in the Servoventilation group [Срок оценки: After 1, 4 and 6 months]
• Adverse events monitoring [Срок оценки: Through study completion, an average of 2 years]
• Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients [Срок оценки: 1, 4 and 6 months after stroke]
• Cardiovascular events evaluation 12 months after stroke in all participants. [Срок оценки: 12 months after stroke]

Критерии участия

Критерии включения

• Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
• Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
• Admission to the hospital within 48 h of stroke symptoms onset.
• Ischemic first stroke diagnosis.
• NIHSS ≥2 at screening.
• Sleep apnea with AHI ≥15.

Критерии исключения

• CSA with Left Ventricular Ejection Fraction ⩽45%.
• Ventilation treatment for sleep apnea diagnosis, prior to stroke.
• Risk of aspiration.
• Nasogastric feeding tube.
• Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
• Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).
• Cardiorespiratory distress.
• Advanced chronic lung disease requiring supplemental oxygen.
• Concomitant central nervous system diseases such as dementia or multiple sclerosis.
• Uncontrolled psychosis or agitation.
• Glasgow Coma Scale (GCS) score <10 at screening.
• Anosognosia, global or Wernicke aphasia.
• Insufficient upper limbs function to use a mask and no overnight caregiver to help.
• Inability to attend to the rehabilitation program of the hospital.
• Pregnant and breast-feeding women.
• Participation in another clinical study (except a standard-of-care registry).
• Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Португалия · 1 центр

• Unidade Local de Saúde de Matosinhos — Matosinhos Municipality

Идентификаторы

NCT: NCT04903951 · PSASV-01-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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