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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00202501
Other study ID # PI030184
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated May 20, 2009
Start date September 2005
Est. completion date March 2009

Study information

Verified date May 2009
Source Sociedad Española de Neumología y Cirugía Torácica
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health and Consumption
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 2009
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- First ever stroke

- Any Sleep Apnea symptom

- Hypertension

Exclusion Criteria:

- Aphasia

- Cognitive impairment

- Hypersomnolence

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Nasal CPAP (Continuous Positive Airway Pressure)


Locations

Country Name City State
Spain Hospital Universitari Sagrat Cor Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurologic recovering
Primary Quality of life
Primary Recurrences
Secondary To assess feasibility of Nasal CPAP treatment in patients with stroke.
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