N/A
Completed N=252
Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure
Source: ClinicalTrials.gov NCT01446913 ↗Enrolled (actual)
252
Serious AEs
6.4%
Results posted
Nov 2020
Primary outcomePrimary: HOMA IR Change From Baseline — 0.9; 4.0; 4.1 HOMA-IR Index
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.
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 | — |
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
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. Informational only — not medical advice.