Short- and long-term continuous positive airway pressure usage in the post-stroke population with obstructive sleep apnea.

PURPOSE: Obstructive sleep apnea (OSA) is highly prevalent in post-stroke patients and observational evidence suggests that untreated it is a harbinger of poorer outcomes in this population. Clinical trials on the impact of treatment of OSA with continuous positive airway pressure (CPAP) have countered difficulties with patient engagement and adherence to CPAP therapy. Real-world data on continuous positive airway pressure initiation and usage in the post-stroke population with obstructive sleep apnea is limited. METHODS: We performed a clinical retrospective study between January 2006 and June 2015 to describe the short- and long-term CPAP usage in the post-stroke population with OSA, and to assess which patient, disease, and treatment-related factors were associated with CPAP purchase, initiation, and usage in this population. RESULTS: Of 191 post-stroke patients' recommended CPAP therapy, post-prescription usage at 3, 6, 12, 24, and 60 months was 58%, 53%, 48%, 45%, and 39% respectively. OSA severity-related factors, such as AHI or degree of nocturnal hypoxemia, were not significantly associated with CPAP usage. Predictors of CPAP usage at all time points were younger age, male sex, never smokers, and no history of hypertension. There were some differences in predictors of CPAP usage between early and later time periods. CONCLUSIONS: We demonstrated that the long-term usage of CPAP therapy is possible with most of the attrition occurring in the first 3 months. Upfront healthcare resource allocation to CPAP initiation and usage in this population may improve longer-term usage.

In-hospital diagnosis of sleep apnea in stroke patients using a portable acoustic device.

PURPOSE: Sleep apnea (SA) is highly prevalent in post-stroke patients. Due to physical disability and relative inaccessibility of polysomnography (PSG) to test for SA, patients with stroke frequently remain undiagnosed and untreated. Portable SA monitoring can facilitate at-home or in-hospital testing for SA. However, portable SA monitoring is not recommended in those with complex medical conditions, such as stroke, due to the lack of validation of portable monitoring in such patients. METHODS: The objective of our study was to test the accuracy and feasibility of a portable single-channel acoustic device, BresoDx™ for quantifying the apnea-hypopnea index (AHI) and diagnosing SA in a post-stroke population. Patients who recently suffered a stroke and were undergoing rehabilitation in a stroke rehabilitation unit (SRU) underwent testing with BresoDx both simultaneously during attended PSG and unattended on the SRU. RESULTS: We studied 23 stroke patients of whom 78% had SA (defined by AHI ≥15) on PSG. All of the patients tolerated the BresoDx. Using cutoff AHI of ≥15 by PSG to diagnose SA, BresoDx had sensitivity of 90.0%, specificity of 84.6%, and overall accuracy of 87.0% in the laboratory. CONCLUSIONS: This study demonstrates that BresoDx is well tolerated and feasible to use in the post-stroke population where it was found to have excellent positive and negative predictive values for the diagnosis of SA.

Research ethics board approval for an international thromboprophylaxis trial.

BACKGROUND: Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. METHODS: We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). RESULTS: Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. CONCLUSIONS: More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards.