Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
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Purpose
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 | Intervention |
|---|---|
|
Sleep Apnea Stroke Cardiovascular Disease |
Device: Nasal CPAP (Continuous Positive Airway Pressure) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Usefulness of Nasal CPAP Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome |
- Neurologic recovering
- Quality of life
- Recurrences
- To assess feasibility of Nasal CPAP treatment in patients with stroke.
| Enrollment: | 80 |
| Study Start Date: | September 2005 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- First ever stroke
- Any Sleep Apnea symptom
- Hypertension
Exclusion Criteria:
- Aphasia
- Cognitive impairment
- Hypersomnolence
Contacts and Locations| Spain | |
| Hospital Universitari Sagrat Cor | |
| Barcelona, Spain, 08329 | |
| Principal Investigator: | Olga Parra, MD | Hospital Universitari Sagrat Cor |
More Information
No publications provided by Sociedad Española de Neumología y Cirugía Torácica
Additional 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 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 20, 2009 |
| Health Authority: | Spain: Ministry of Health and Consumption |
Additional relevant MeSH terms:
|
Apnea Cardiovascular Diseases Sleep Apnea Syndromes Stroke Cerebral Infarction Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic |
Dyssomnias Sleep Disorders Nervous System Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 21, 2013