Informations générales (source: ClinicalTrials.gov)

NCT02554487 Statut inconnu
Early Sleep Apnea Treatment in Stroke: A Multicenter, Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation
Interventional
  • Apnée
  • Syndromes d'apnées du sommeil
  • Syndrome d'apnées obstructives du sommeil
  • Apnée centrale du sommeil
  • Accident vasculaire cérébral
N/A
Insel Gruppe AG, University Hospital Bern (Voir sur ClinicalTrials)
août 2015
novembre 2022
13 septembre 2025
Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major importance. First because of the high occurrence rate of stroke and the fact that it is a frequent cause of long-term disability in adulthood. Second because SDB (obstructive, central and mixed forms) affects more than 50% of stroke survivors and has a detrimental effect on clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation. Therefore, it is crucial to investigate whether early treatment of SDB with Adaptive Servo-Ventilation (ASV), the treatment device of choice to treat obstructive, central and mixed forms of SDB, has a beneficial effect on the evolution of the lesion volume and on clinical stroke outcome. To this end, the investigators recruit and prospectively follow 3 groups of patients with ischemic stroke over 1 year. During the first night after hospital admission due to acute stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) > 20/h, are randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts the second night following hospital admission and ends 90 days later. Stroke patients without SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the lesion volume and stroke outcome without the additional burden of SDB. Lesion volume one day after hospital admission due to acute stroke (after potential lysis therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as patients without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by clinical scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke. Cognitive outcome is assessed during hospitalization (within the first week following stroke) and after the treatment period of 90 days by neuropsychological tests assessing attention and memory. In addition, baseline assessment of physiological parameters such as blood pressure and endothelial function/arterial stiffness are assessed during the first weeks following stroke and at the end of the treatment period, i.e. approximately 90 days following stroke.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Clinic universitaire de physiologie, sommeil et exercice, Centre Hospitalier Universitaire (CHU) de Grenoble - 38043 - Grenoble - France Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Informed consent as documented by signature

- Admission to one of the participating centers

- Age 18-85 years

- Ischemic stroke detectable by neuroimaging, affecting internal carotid artery,
anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral
artery (PCA) and/or branches thereof

- Symptom onset to admission < 24 hours

- AHI > 20/h or < 5/h

Exclusion Criteria

- Primary hemorrhagic stroke

- Secondary parenchymal haemorrhage (PH 1 and PH 2 according to ECASS; secondary
haemorrhagic infarction HI 1 and HI 2 can be included)

- Small strokes (diameter < 1.5cm)

- Coma/Stupor

- Intubation

- Clinically unstable or life threatening condition (oxygen-dependent pulmonary
disease or severe pulmonary complications, severe renal or liver insufficiency,
agitated patient, patients under blood pressure-elevating substances >24h after
stroke, patients that need decompressive craniectomy )

- Heart failure defined as known congestive heart failure (CHF) functional class NYHA
III-IV (New York Heart Association) OR CHF NYHA II and hospitalization caused by CHF
in the preceding 24 months

- OR left ventricular ejection fraction lower or equal 45% either known from preceding
imaging method or found at the routine examination (echocardiography) during
hospitalization

- Oxygen supply > 2 l/min during day and night

- Intermediate AHI value: ≥ 5/h and ≤ 20/h

- Known progressive neurological diseases (such as dementia, Parkinson's disease or
multiple sclerosis)

- Drug or alcohol abuse (>14 units alcohol / week for males, >7 units alcohol / week
for females)

- Inability to follow study procedure

- Pregnancy

- Any given contraindications to MRI or MRI-contrast agent (allergy or severe renal
impairment)

- Any given contraindications to ASV treatment

- Patients with clinical symptoms of COVID-19 infection during initial hospitalization