Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Peripheral Vascular Disease, Neurology, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | May 2011 |
| End Date: | April 2014 |
The goal of this study is to develop a novel study design to safely and ethically conduct a
long-term randomized controlled trial among patients at high risk for both sleep apnea and
cardiovascular events that will examine whether effective positive airway pressure(PAP)
therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke
have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular
events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular
death)in the first year post event, despite current prevent strategies. Therefore, the
treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular
outcomes in this high risk population.
long-term randomized controlled trial among patients at high risk for both sleep apnea and
cardiovascular events that will examine whether effective positive airway pressure(PAP)
therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke
have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular
events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular
death)in the first year post event, despite current prevent strategies. Therefore, the
treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular
outcomes in this high risk population.
The proposed study is a randomized controlled trial among patients with transient ischemic
attack (TIA) and minor stroke, comparing strategies for the diagnosis and treatment of sleep
apnea with usual care over 6-12 months at 2 sites (Yale University School of Medicine and
Indiana University School of Medicine). Patients with TIA and minor stroke will be randomly
assigned to either usual care or a diagnosis and treatment approach that includes ambulatory
polysomnography and initiation of autotitrating CPAP for sleep apnea in a 1:2
(control:intervention) randomization scheme. Intervention patients with sleep apnea will
receive either a standard CPAP treatment intervention or an enhanced protocol designed to
increase long-term CPAP adherence. The primary outcomes will include: (a) the impact of CPAP
on pathophysiologic markers in the following domains of cardiovascular risk: inflammation
(CRP, Il-6), heightened sympathetic activity/parasympathetic withdrawal (plasma
catecholamines and heart rate variability (HRV)), insulin resistance (HOMA-IR, HbA1C),
endothelial injury (flow mediated vasodilation), and atherosclerosis (carotid intima-media
thickness); and (b) long-term (6-12 month) CPAP adherence.
attack (TIA) and minor stroke, comparing strategies for the diagnosis and treatment of sleep
apnea with usual care over 6-12 months at 2 sites (Yale University School of Medicine and
Indiana University School of Medicine). Patients with TIA and minor stroke will be randomly
assigned to either usual care or a diagnosis and treatment approach that includes ambulatory
polysomnography and initiation of autotitrating CPAP for sleep apnea in a 1:2
(control:intervention) randomization scheme. Intervention patients with sleep apnea will
receive either a standard CPAP treatment intervention or an enhanced protocol designed to
increase long-term CPAP adherence. The primary outcomes will include: (a) the impact of CPAP
on pathophysiologic markers in the following domains of cardiovascular risk: inflammation
(CRP, Il-6), heightened sympathetic activity/parasympathetic withdrawal (plasma
catecholamines and heart rate variability (HRV)), insulin resistance (HOMA-IR, HbA1C),
endothelial injury (flow mediated vasodilation), and atherosclerosis (carotid intima-media
thickness); and (b) long-term (6-12 month) CPAP adherence.
Inclusion Criteria:
- 18 years and older
- TIA or ischemic stroke
- within 1 week of neurological symptom onset
- brain imaging within 24 hours
Exclusion Criteria:
- known to have sleep apnea
- suspected sleep disorder other than sleep apnea
- hospice patients or patients receiving comfort only measures
- patients unable to use a nasal or face mask
- patients who require mechanical ventilation
- Non English language patients
- inability to provide informed consent
- active suicidal ideation
- live outside the recruitment area
- provider does not allow researcher to contact patient
We found this trial at
2
sites
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