Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202501
Status:
COMPLETED
Last Update Posted:
2009-05-21
First Post:
2005-09-12
Brief Title:
Usefulness of Nasal Continuous Positive Airway Pressure CPAP Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Organization:
Sociedad Española de Neumología y Cirugía Torácica
Study Overview
Official Title:
Usefulness of Nasal CPAP Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IndexCanadian 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
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 IndexCanadian 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None