Clinical trial NCT01446913: Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure
Official title: Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transient Ischemic Attack
Stroke
Keywords: Sleep Apnea
CPAP adherence
behavioral adherence
stroke
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Indiana University
First posted: 2011-10-05
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: HOMA IR Change From Baseline
timeFrame: Baseline and up to 12 months
measure: CRP Change From Baseline
timeFrame: Baseline and up to 12 months
measure: IL-6 Change From Baseline
timeFrame: Baseline and up to 12 months
measure: Catecholamine Change From Baseline
timeFrame: Baseline and up to 12 months
measure: Heart Rate Variability Change From Baseline
timeFrame: Baseline and up to 12 months
measure: 24-H Systolic Blood Pressure Mean Change From Baseline
timeFrame: Baseline and up to 12 months
measure: Flow-mediated Vasodilation Mean Change From Baseline
timeFrame: Baseline to up to 12 months
measure: Carotid Intima-Medial Thickness Mean Change From Baseline
timeFrame: Baseline to up to 12 months
measure: CPAP Adherence Rates Change From Baseline
timeFrame: Baseline to up to 12 months
Secondary outcomes:
measure: HOMA IR Change From Baseline With CPAP Use
timeFrame: Baseline to up to 12 months
measure: CRP Change From Baseline With CPAP Use
timeFrame: Baseline to up to 12 months
measure: IL-6 Change From Baseline With CPAP Use
timeFrame: Baseline to up to 12 months
measure: Catecholamine Change From Baseline With CPAP Use
timeFrame: Baseline to up to 12 months
measure: Heart Rate Variability Change From Baseline With CPAP Use
timeFrame: Baseline to up to 12 months
measure: 24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use
timeFrame: Baseline to up to 12 months
measure: Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use
timeFrame: Baseline to up to 12 months
measure: Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change
timeFrame: Baseline to up to 12 months
measure: Medication-adjusted 24-H SBP Change From Baseline
timeFrame: Baseline to up to 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Indianapolis
country: United States
facility: University of Indiana
state: Indiana
Study officials:
affiliation: Yale University
name: Henry Yaggi, MD,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Dawn M Bravata, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koo BB, Bravata DM, Tobias LA, Mackey JS, Miech EJ, Matthias MS, Stahl SM, Sico JJ, Vaz Fragoso CA, Williams LS, Lampert R, Qin L, Yaggi HK. Observational Study of Obstructive Sleep Apnea in Wake-Up Stroke: The SLEEP TIGHT Study. Cerebrovasc Dis. 2016;41(5-6):233-41. doi: 10.1159/000440736. Epub 2016 Jan 27.
citation: Yaggi HK, Mittleman MA, Bravata DM, Concato J, Ware J, Stoney CM, Redline S. Reducing cardiovascular risk through treatment of obstructive sleep apnea: 2 methodological approaches. Am Heart J. 2016 Feb;172:135-43. doi: 10.1016/j.ahj.2015.07.033. Epub 2015 Sep 11.