Clinical Research Directory

Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.

Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure

Thick meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration syndrome or persistent pulmonary hypertension. Although amnioinfusion or placing sterile fluid into the uterus during labor was previously studied as a way to reduce these complications, earlier research had major limitations. Past studies included all types of meconium, used different fluid types and temperatures, had inconsistent protocols, and did not measure biomarkers of inflammation or look at long-term outcomes. As a result, it is still unclear whether a modern, standardized approach to amnioinfusion can meaningfully improve newborn health when the meconium is truly thick. The PEARL Trial is a randomized clinical trial designed to answer this question. The study will enroll pregnant individuals at or beyond 36 weeks of gestation who develop thick meconium-stained amniotic fluid, confirmed using a simple, objective measurement ("meconium-crit"). Participants will be randomly assigned to receive either: Warm lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion. The main goal is to determine whether warm LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical cord blood at birth to evaluate markers of inflammation and potential brain injury, which may help explain why some infants develop complications. Families will also be contacted when their child is 12 months old to complete a developmental questionnaire that is widely used in pediatric practice. By using a clear definition of thick meconium, a warm LR infusion protocol, fidelity checklists, and long-term follow-up, this trial aims to provide high-quality evidence to guide care in labor and delivery units nationwide.

Sleep for Stroke Management and Recovery Trial

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Sleep Apnea Triggers of Atrial Fibrillation: N-of-1 Randomized Control Trial (SPARTA):

A pilot N-of-1 randomized controlled trial evaluating the effectiveness of a personalized CPAP intervention in reducing atrial fibrillation (AF) burden and improving AF-related quality of life in patients with moderate to severe obstructive sleep apnea (OSA).

Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal

In brief, the proposed study will evaluate a recently proposed naturalistic, driving simulation test to identify and measure sleepiness behind the wheel, one of the most underestimated causes of road accidents. The proposed test offers higher ecological validity and might complement somnological tests that are standard, but rarely performed. Thus, the test might provide traffic medicine and sonologists with an effective tool, that can also directly convey the risks of excessive daytime sleepiness to drivers and thus, in combination, effectively aid in traffic medicine's mandate to avoid preventable road fatalities. Excessive daytime sleepiness (EDS) is a symptomatic condition resulting from too little or compromised sleep, caused by psycho-social stress (shiftwork, lifestyle) or medical conditions (obstructive sleep apnoea (OSA), narcolepsy). Driving with untreated EDS might lead to sleepy/drowsy driving and microsleep, which is considered to be one of the highest-ranking causes of road accidents. Sleepiness and its dangers on the wheel might subjectively not be registered by the affected drivers. Also, subjective sleepiness might not correlate with somnological measurements that are also crucial for legally determining the fitness to drive (FTD). There exists a variety of partially complementary tools to evaluate the extent of EDS. Mean sleep latency obtained in the maintenance of wakefulness test (MWT) is widely, but not uniformly, considered to be one of the most objective measures to evaluate EDS, especially in the context of driving performance. However, there is inconsistent or insufficient evidence for MWTs to reliably predict the FTD in general, potentially as its result might be strongly influenced by motivation. Moreover, patients might not relate low mean MWT-latencies to their own and other's risks in traffic. A need for improved tools to measure EDS was formulated. It remains open, whether the MWT should be replaced or complemented by, for example, future road-side metabolomics-tests detecting sleepiness in traffic or whether the MWT should be adapted to better convey a.) the risks of EDS in traffic and b.) its meaning for the determination of the FTD. With this need in mind the investigators proposed furnishing the maintenance of wakefulness test with improved ecological validity to provide an improved tool for the assessment of the effect of excessive daytime sleepiness on the fitness to drive: recently published results from an exploratory feasibility study suggested it to be well possible to transfer the MWT-paradigm to a driving simulator (DS) with high user acceptance. The published result's implication and relevance was well received: the new test, DS-MWT, might complement somnological MWTs in pneumology and neurology. I might provide a naturalistic and relatable tool to determine EDS in traffic medicine, who is institutionally responsible for determining the FTD. This is also desirable, because prohibitively high cost - in time, money and instrumentation - often prevent a standard MWT in standard care of sleep-related medical conditions. Potentially, the use of the DS-MWT might help reduce the number of preventable road fatalities by more often identifying sleepy individuals before they get behind the wheel. However, for this goal to be achieve, it remains to be evaluated whether the latencies obtained in classical or simulation conditions are comparable and whether obtained latencies actually reflect other clinical parameters of EDS relating to underlying medical conditions, such as for example OSA. This represents a significant gap of evidence for both medical experts in pneumology and traffic medicine, but also for affected drivers. This gap will be filled by systematically comparing classical and simulation-based MWTs by means of their resulting latencies. In a within-study setup of 36 highly adherent OSA-patients, experiments will be related to a main medical comparator, a ≥7-day continuous positive airway pressure (CPAP)-withdrawal (W) and subsequent -resumption or continuation (C), respectively. There will be a control group of 18 healthy participants for comparison.

Obstructive Sleep Apnea (OSA), Oral Frailty, Dysphagia, Continuous Positive Airway Pressure (CPAP)

The purpose of this study is to evaluate the effects of the CPAP treatment on oral frailty and dysphagia among OSA patients.

Treatment of Sleep Apnea to Improve Metabolic Health

Diabetes and prediabetes prevail among obstructive sleep apnea (OSA) patients. OSA and short sleep both detrimentally affect glycemic control regardless of obesity. With 1 in 10 adults having diabetes, 1 in 10 with prediabetes, and an estimated 600,000 affected by OSA in Sweden, attaining glycemic control is crucial. Though continuous positive airway pressure (CPAP) is the most effective treatment for OSA, its application lacks personalization, ignoring factors like comorbidities and sleep duration. Key unanswered questions regarding CPAP's impact on glycemic control include: 1) Does high CPAP adherence optimize glycemic control? 2) Should short sleep be addressed alongside OSA treatment for glycemic control? 3) Does long-term diabetes hinder CPAP's glycemic control efficacy? The purpose of this project is to enable precision health in CPAP treatment and producing a personalized treatment model for achieving glycemic control in patients with OSA, treated with CPAP. Taking advantage of a large unique patient cohort (600 patients followed over 18 months) with extensive and objective measures on CPAP adherence, OSA reduction, sleep duration, as well as information on comorbidities, anthropometric, lifestyle data, and a wide range of biomarkers related to glycemic control. This comprehensive approach and in-depth analysis will address these questions and generate a personalized treatment strategy for glycemic control in CPAP-treated OSA patients.