Investigator-initiated, phase 3 multicenter, prospective randomized open-, blinded-endpoint (PROBE) controlled trial to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure is effective for secondary prevention and recovery after stroke.
Patients with recent (?14 days) acute ischemic stroke or high-risk TIA (ABCD2 ?4) are enrolled during their acute or rehabilitation hospitalization and treated for 6 months. After consent, a portable cardiopulmonary sleep apnea test (the Nox T3) is used to screen for OSA (AHIT3?10) and to exclude central sleep apnea (where CAI ?50% of the total AHIT3). aCPAP is then used on one night to determine tolerability (the "run-in" night). Subjects who use the device for ?4 hours on that night, and do not have excessive treatment-emergent central sleep apnea (CAI remains <10 on aCPAP machine-generated data), are randomized to receive either 6 months of aCPAP plus usual medical therapy, or usual medical therapy alone. Adherence information is provided to subjects in the intervention group, to offer education about treatment and to increase treatment adherence. Subjects and their caregivers also are taught about aCPAP use. Through a centralized service, managed by FusionHealth, adherence to aCPAP is monitored in nearly real time in most cases by wireless means, and supported remotely throughout the treatment period.
This study is gathering patient information and a saliva sample from people who have had a type of stroke called an intracerebral hemorrhage (ICH). Risk factors will be identified and analyzed for their contribution to the ICH as well as their effect on long term patient outcomes. Patients will be contacted over phone at 3 and 12 months after enrollment and asked a series of short questions about how they are feeling, how hard or easy it is to perform daily tasks, and any change in medication.
The PREMIERS study is a proposal for conducting an adequately powered two center phase III randomized controlled trial to test whether intensive periodontal treatment reduces the risk of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the resources in both states including established
dental centers, Joint Commission Certified Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate Health Disparities. The proposal addresses specific issues with regards to recruitment of African-American and rural stroke/TIA patients advocating the use of culturally appropriate strategies to educate the study subjects regarding stroke, periodontal disease and the periodontal stroke link.
The study proposes to utilize economic evaluation of the periodontal intervention from the budgetary
perspective. The focus will be on the financial sustainability of providing aggressive periodontal therapy (with
certain, although relatively low expenditures) in exchange for a reduction of uncertain recurrent vascular events
that may require high cost emergency department utilization and/or inpatient care. The sustainability of the
proposed intervention after the completion of the project is integrally linked to the health economic assessment
to show the health care cost savings. By integration with a rural primary care center, with an African American
majority and households with average incomes below the state average, the study ensures that the proposed
intervention to reduce stroke disparity is applicable to this target population.