Clinical trials

The goal of this observational study is to learn if there are potential digital and plasma-based biomarkers that could help detect, predict, and prognosticate delirium in older adult patients who are admitted to the intensive care unit (ICU). The main question DELTA aims to answer is: Can digital biometrics predict and detect delirium in older adult ICU patients? Do biomarkers of neurodegeneration fluctuate in ICU patients in such a way that delrium could potentially be predicted? Participants admitted o the ICU will wear a digital device to collect biometric data and will have serial plasma samples collected during ICU admission and patients will be also assessed for delirium daily by study staff.

This randomized, phase I/II, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.

This study will test the sensitivity of a novel, battery-powered, non-invasive ultrasound device to detect a right-to-left shunt

The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.

Restless legs syndrome is a common sleep-related movement disorder that affects up to 15% of the population in North America, characterized by an uncomfortable urge to move the legs. This has been associated with poor quality of sleep and overall decreased quality of life. Chronic inflammation has been implicated as a key mediator of the low intracranial iron stores that characterize restless legs syndrome (RLS). Current medications for RLS target concomitant low serum iron levels or the dopaminergic pathway, but none target the inflammatory pathway. A novel therapy that focuses on inflammation would allow for additional research into the role of inflammation and cytokines in the development of RLS, and potentially unlock a new class of medications to treat patients with RLS. A small amount of prior evidence suggest that RLS symptoms improve with steroids, with associated improved quality of life, and with decreasing hepcidin levels as a biomarker of symptom severity. This pilot study, using an RCT design, serves to assess the efficacy of glucocorticoids in the alleviation of RLS symptoms, which would further anchor the association between RLS, inflammation, and one of its potential mediators - hepcidin. By giving a prednisone taper versus placebo, this study primarily aims to assess the effect of glucocorticoids on 1) decreasing RLS symptom severity. This study also aims to measure 2) objectively measured improvement in sleep, 3) changes in baseline and post-treatment hepcidin levels, and 4) prevalence of adverse events including psychosis and weight gain. RLS can be a debilitating disease and several non-traditional medications have been tested but with unequivocal results. Glucocorticoids may be an easily accessible and affordable key to better quality of life for RLS patients, especially those with refractory RLS.

Sleep is an important part of the healing process, and patients admitted to the hospital often report poor sleep. Patients have difficulty not only falling sleep, but also staying asleep. Prior studies show that hospital noise may be a contributing factor, and in particular, sound level changes (which refers to an increase in sound above the background/baseline noise level) may cause arousals from sleep. Based on preliminary data, this study aims to use white noise to reduce the number of relevant sound level changes that occur during a night of sleep in the hospital. Using a randomized, cross-over design, the investigators aim to enroll 45 inpatient adults (age ≥ 65 years) to receive "active," white noise (white noised played at 57-60 decibels) on one night of their stay, and "inactive," white noise (white noise played at 45-50 decibels) on an alternate night. Three major primary outcomes will be investigated - 1) objective sleep duration as measured using actigraphy, 2)objectively measured sleep fragmentation using actigraphy, and 3) subjective sleep quality using the Richards Campbell Sleep Questionnaire. Secondary outcomes will include sound level changes in the room (measured using sound meters), as well as morning blood glucose (for diabetic/prediabetic patients) and blood pressure measurements. Delirium will be measured twice daily through the inpatient stay in a secondary analysis to compare levels of sleep fragmentation to delirium incidence.