Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
Primary Purpose
Sleep Apnea, Stroke, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nasal CPAP (Continuous Positive Airway Pressure)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
Eligibility Criteria
Inclusion Criteria: First ever stroke Any Sleep Apnea symptom Hypertension Exclusion Criteria: Aphasia Cognitive impairment Hypersomnolence
Sites / Locations
- Hospital Universitari Sagrat Cor
Outcomes
Primary Outcome Measures
Neurologic recovering
Quality of life
Recurrences
Secondary Outcome Measures
To assess feasibility of Nasal CPAP treatment in patients with stroke.
Full Information
NCT ID
NCT00202501
First Posted
September 12, 2005
Last Updated
May 20, 2009
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
1. Study Identification
Unique Protocol Identification Number
NCT00202501
Brief Title
Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
Official Title
Usefulness of Nasal CPAP Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Stroke, Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Nasal CPAP (Continuous Positive Airway Pressure)
Primary Outcome Measure Information:
Title
Neurologic recovering
Title
Quality of life
Title
Recurrences
Secondary Outcome Measure Information:
Title
To assess feasibility of Nasal CPAP treatment in patients with stroke.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First ever stroke
Any Sleep Apnea symptom
Hypertension
Exclusion Criteria:
Aphasia
Cognitive impairment
Hypersomnolence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Parra, MD
Organizational Affiliation
Hospital Universitari Sagrat Cor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Sagrat Cor
City
Barcelona
ZIP/Postal Code
08329
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
34739082
Citation
Reynor A, McArdle N, Shenoy B, Dhaliwal SS, Rea SC, Walsh J, Eastwood PR, Maddison K, Hillman DR, Ling I, Keenan BT, Maislin G, Magalang U, Pack AI, Mazzotti DR, Lee CH, Singh B. Continuous positive airway pressure and adverse cardiovascular events in obstructive sleep apnea: are participants of randomized trials representative of sleep clinic patients? Sleep. 2022 Apr 11;45(4):zsab264. doi: 10.1093/sleep/zsab264.
Results Reference
derived
PubMed Identifier
20847081
Citation
Parra O, Sanchez-Armengol A, Bonnin M, Arboix A, Campos-Rodriguez F, Perez-Ronchel J, Duran-Cantolla J, de la Torre G, Gonzalez Marcos JR, de la Pena M, Carmen Jimenez M, Masa F, Casado I, Luz Alonso M, Macarron JL. Early treatment of obstructive apnoea and stroke outcome: a randomised controlled trial. Eur Respir J. 2011 May;37(5):1128-36. doi: 10.1183/09031936.00034410. Epub 2010 Sep 16.
Results Reference
derived
Learn more about this trial
Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
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