Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome

Not Applicable

Completed

• Conditions: Sleep Apnea; Stroke; Cardiovascular Disease

• Registration Number: NCT00202501
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-12
• Study Completion: 2009-03
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-20
• Last Update Posted: 2009-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• First ever stroke
• Any Sleep Apnea symptom
• Hypertension

Exclusion Criteria

• Aphasia
• Cognitive impairment
• Hypersomnolence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neurologic recovering
Recurrences
Quality of life

Secondary Outcome Measures

Name	Time	Method
To assess feasibility of Nasal CPAP treatment in patients with stroke.

Trial Locations

Locations (1)

Hospital Universitari Sagrat Cor; 🇪🇸 Barcelona, Spain