Background: Vestibular Hypofunction (VH) and hearing loss can affect quality of life and lead to disability, especially in the elderly. Studies investigating presbycusis and vestibular function in the aging population have been conducted separately, but few have examined the combination of both conditions in older patients, with inconsistent results that may be due to small sample sizes or heterogeneity in the methods used to assess vestibular function. We aimed to characterize the occurrence of VH in patients with presbycusis using the video head impulse test (vHIT), which is a specific and reliable assessment tool for VH. Methods: A prospective, cross-sectional study of 200 individuals was conducted at Hamad Medical Corporation-Qatar in Doha, Qatar. Adults aged 50 years and older with bilateral age-related hearing loss were screened for eligibility and those who were eligible completed the vHIT. Patient history, demographics, audiological and clinical data were collected. VH was defined as vestibulo-ocular reflex (VOR) gain of <0.79 and presence of corrective saccades. Results: In our study population, (n = 200 mean age 64.1 ± 8.4 [Range = 37], 31.5% females), VH was identified in 12 out of 200 patients (6.0%, 95% CI: 3.3–10.1) with bilateral age-related hearing loss (ARHL), equivalent to approximately 1 in 17 patients. VH was detected in the left ear in 11 patients (5.5%, 95% CI: 2.9–9.9), the right ear in five patients (2.5%, 95% CI: 0.8–5.8), and bilaterally in four patients (2.0%, 95% CI: 0.6–5.4). Conclusions: In our study population, vestibular hypofunction was observed in 6% of patients with bilateral symmetrical age-related sensorineural hearing loss, suggesting that vestibular screening may be useful in this population at risk.
Background: End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin’s efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Objective: The overall objective of this protocol is to (1) evaluate aspirin’s safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin’s efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups. Methods: We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed. Results: The randomized clinical trial will be performed after approval by the ethical committee of the participating center and registration at ClinicalTrials.gov. Conclusions: We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events. Registered Report Identifier: RR1-10.2196/10516
BACKGROUND End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin’s efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. OBJECTIVE The overall objective of this protocol is to (1) evaluate aspirin’s safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin’s efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups. METHODS We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed. RESULTS PLEASE WRITE RESULTS. CONCLUSIONS We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events.