Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
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|ClinicalTrials.gov Identifier: NCT00202501|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 21, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Stroke Cardiovascular Disease||Device: Nasal CPAP (Continuous Positive Airway Pressure)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Usefulness of Nasal CPAP Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||March 2009|
- Neurologic recovering
- Quality of life
- To assess feasibility of Nasal CPAP treatment in patients with stroke.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202501
|Hospital Universitari Sagrat Cor|
|Barcelona, Spain, 08329|
|Principal Investigator:||Olga Parra, MD||Hospital Universitari Sagrat Cor|