Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure "Sleep Tight"

Completed

Phase 2 Results N/A

Update History

1 Aug '15
A location was updated in New Haven.
New
The overall status was removed for Yale University.
A location was updated in Indianapolis.
New
The overall status was removed for University of Indiana.
14 Nov '13
Trial name was updated.
New
Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure
A location was updated in New Haven.
New
The overall status was removed for Yale University.
2 May '13
Trial name was updated.
New
Treatment Study of Sleep Apnea Among Patients With Transient Ischemic Attack and Minor Stroke
The description was updated.
New
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.
Old
This proposed project will provide the data needed to plan a future effectiveness strategy trial of CPAP among patients with transient ischemic attack(TIA) and Stroke to reduce cardiovascular events.
19 Mar '13
The description was updated.
New
This proposed project will provide the data needed to plan a future effectiveness strategy trial of CPAP among patients with transient ischemic attack(TIA) and Stroke to reduce cardiovascular events.
Old
This proposed project will provide the data needed to plan a future effectiveness strategy trial of CPAP among patients with transient ischemic attack(TIA) and Stroke to reduce cardiovascular events. The Primary Aims of the currently proposed project consist of intermediate markers of cardiovascular risk, the optimal CPAP adherence level to achieve these improvements, and whether an enhanced intervention protocol results in improved long-term CPAP adherence rates.
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - 18 years and older - TIA or ischemic stroke - within 1 week of neurological symptom onset 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