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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
Sponsor:
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea




Primary Outcome Measures :
  1. Neurologic recovering
  2. Quality of life
  3. Recurrences

Secondary Outcome Measures :
  1. To assess feasibility of Nasal CPAP treatment in patients with stroke.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First ever stroke
  • Any Sleep Apnea symptom
  • Hypertension

Exclusion Criteria:

  • Aphasia
  • Cognitive impairment
  • Hypersomnolence

Information from the National Library of Medicine

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


Locations
Spain
Hospital Universitari Sagrat Cor
Barcelona, Spain, 08329
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Olga Parra, MD Hospital Universitari Sagrat Cor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PII Sueño SEPAR
ClinicalTrials.gov Identifier: NCT00202501     History of Changes
Other Study ID Numbers: PI030184
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 21, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Stroke
Apnea
Cardiovascular Diseases
Sleep Apnea Syndromes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders