Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure (SleepTight)

Yale University

Status: Completed

Conditions: Stroke; Transient Ischemic Attack

Treatments: Behavioral: Enhanced CPAP Intervention; Device: Standard CPAP Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01446913

U34HL105285-01 (U.S. NIH Grant/Contract)

1101007811

Details and patient eligibility

About

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.

Full 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.

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

255 participants in 3 patient groups

Standard Intervention group

Active Comparator group

Description:

This group gets unattended sleep study, auto titrating CPAP, and standard CPAP support.

Treatment:

Device: Standard CPAP Intervention

Enhanced CPAP intervention

Active Comparator group

Description:

This group gets an unattended sleep study, autotitrating CPAP, and enhanced CPAP support.

Treatment:

Behavioral: Enhanced CPAP Intervention

Usual Care

No Intervention group

Description:

This group usual care after TIA/stroke and a sleep study at the end of the study.