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Recruiting NCT04903951

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

Phase II Interventional Stroke Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adaptive Servoventilation (ASV) therapy, Best medical treatment.
Who it may be relevant to
Registry conditions: Stroke, Sleep Apnea. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Device 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
  • Other Best medical treatment
    Best medical treatment for stroke, including rehabilitation

Primary outcome measures

  • Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke. [Time frame: 1 month after stroke]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 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™ [Time frame: Within 7 days after admission]
  • Adherence in the Servoventilation group [Time frame: After 1, 4 and 6 months]
  • Efficacy in the Servoventilation group [Time frame: After 1, 4 and 6 months]
  • Adverse events monitoring [Time frame: Through study completion, an average of 2 years]
  • Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients [Time frame: 1, 4 and 6 months after stroke]
  • Cardiovascular events evaluation 12 months after stroke in all participants. [Time frame: 12 months after stroke]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Portugal · 1 center
  • Unidade Local de Saúde de Matosinhos — Matosinhos Municipality

Identifiers

NCT: NCT04903951 · PSASV-01-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗