Sleep for Stroke Management and Recovery Trial

Overview

Información sobre este estudio

The primary objectives of this study are to determine whether treatment of OSA with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • TIA with ABCD2 ≥ 4 or ischemic stroke within the prior 14 days.

Exclusion Criteria:

  • Individuals < 18 years old.
  • Pre-event inability to perform all of own basic ADLs.
  • Unable to obtain informed consent from subject or legally authorized representative.
  • Incarcerated.
  • Known pregnancy.
  • Current mechanical ventilation (can enroll later if this resolves) or tracheostomy.
  • Current use of positive airway pressure, or use within one month prior to stroke.
  • Anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible.
  • Severe bullous lung disease.
  • History of prior spontaneous pneumothorax or current pneumothorax.
  • Hypotension requiring current treatment with pressors (can enroll later if this resolves).
  • Other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP.
  • Massive epistaxis or previous history of massive epistaxis.
  • Cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus.
  • Recent hemicraniectomy or suboccipital craniectomy (i.e., those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure.
  • Current receipt of oxygen supplementation > 4 liters per minute.
  • Current contact, droplet, or respiratory/airborne precautions.

Eligibility last updated 8/30/21. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Oana Dumitrascu, M.D.

Abierto para la inscripción

Contact information:

Stephanie Ruiz Morales

(480) 301-4282

RuizMorales.Stephanie@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20519960

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