N/A N=252 Randomized Single-blind Treatment

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

Transient Ischemic Attack · Stroke

Bottom Line

View on ClinicalTrials.gov: NCT01446913 ↗

Enrolled (actual)

252

Serious AEs

6.4%

Results posted

Nov 2020

Primary outcome: Primary: HOMA IR Change From Baseline — 0.9; 4.0; 4.1 HOMA-IR Index

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Standard CPAP Intervention (Device); Enhanced CPAP Intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY HOMA IR Change From Baseline	0.9; 4.0; 4.1	—
PRIMARY CRP Change From Baseline	0.8; 0.9; -3.0	—
PRIMARY IL-6 Change From Baseline	4.0; 1.8; -0.7	—
PRIMARY Catecholamine Change From Baseline	192.4; 5.8; 89.0	—
PRIMARY Heart Rate Variability Change From Baseline	-8.0; 5.0; -1.5	—
PRIMARY 24-H Systolic Blood Pressure Mean Change From Baseline	0.6; -1.2; 5.9	—
PRIMARY Flow-mediated Vasodilation Mean Change From Baseline	1.0; 0.1; -0.3	—
PRIMARY Carotid Intima-Medial Thickness Mean Change From Baseline	0.0; 0.0; 0.0	—
PRIMARY CPAP Adherence Rates Change From Baseline	3.9; 4.3	—
SECONDARY HOMA IR Change From Baseline With CPAP Use	-0.2; 2.4; 3.3	—
SECONDARY CRP Change From Baseline With CPAP Use	0.8; 0.9; -3.0	—
SECONDARY IL-6 Change From Baseline With CPAP Use	-5.3; 3.3; 11.9	—
SECONDARY Catecholamine Change From Baseline With CPAP Use	76.7; -27.8; 184	—
SECONDARY Heart Rate Variability Change From Baseline With CPAP Use	3.2; -5.4; 5.3	—
SECONDARY 24-H Mean Systolic Blood Pressure Change From Baseline With CPAP Use	3.8; -4.9; 0.1	—
SECONDARY Flow-mediated Vasodilation Mean Change From Baseline With CPAP Use	-0.7; 2.7; 0.3	—
SECONDARY Carotid Intima-Medial Thickness Change From Baseline With CPAP Use Change	0.0; 0.0; 0.0	—
SECONDARY Medication-adjusted 24-H SBP Change From Baseline	7.8; 5.3; 0.1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01446913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.