Stroke Clinical Trial
Official title:
Usefulness of Nasal CPAP Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
MAIN AIMS: to analyze the efficacy of nasal CPAP treatment in patients with ischemic
first-ever stroke and Sleep Apnea Syndrome (SAS) in terms of: early neurological outcome,
functional recovery, quality of life influence, stroke recurrence and survival.
SECONDARY AIMS: to evaluate the feasibility of the treatment in this type of patients at
short and long time.
DESIGN: clinical randomized case-control study.
PATIENTS: younger than 75 years with a First-Ever stroke with at least one of the following
criteria: snoring, observed apnea, Hypertension or Ischemic Cardiopathy.
MEASUREMENTS: protocol to define subtype stroke and parenchymatous and vascular location;
sleep questionnaire (including Epworth Sleepiness Scale); Respiratory Polysomnography
(RPSG). If RPSG shows an AHI > 20, with predominant obstructive events, patients will be
randomized in a CONTROL GROUP (conventional treatment) and a TREATMENT GROUP (with Nasal
CPAP). Follow up for both groups at 1, 3, 12 and 24 months will include: early neurological
outcome, body mass index (BMI), blood pressure (BP), functional recovery (Barthel
Index/Canadian Scale), quality of life (SF36), recurrences, vital status. Nasal CPAP
titration will be performed by means of an automatic system (Autoset Portable ST).
Compliance will be recorded. If a negative RPSG is obtained (AHI < 10) (NO SAS GROUP) or
with AHI < 20 (mild SAS) the usual treatment and the same follow up protocol will be
established.
STATISTICS: the sample size is initially calculated in 10 patients for each group,
considering this is part of a multicenter study including 8 centers. If no differences are
found, depending on the statistical power the investigators will consider including more
patients. The different groups will be compared for the analyzed variables with the
corresponding tests.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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