[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cpap\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cpap":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,58,86,116,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":40,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100614048","amnioinfusions-protective-effects-on-respiratory-and-longitudinal-pediatric-outcomes-after-intrapartum-thick-meconium-exposure-100614048",false,"NCT07274527","Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure","The PEARL Trial: A Randomized Trial of Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure","PEARL","Inclusion Criteria:\n\n* Maternal age greater than or equal to 18 years old\n* Singleton pregnancy\n* Gestational age of greater than or equal to 36 weeks 0 days gestation\n* Cephalic presentation\n* Cercial dilation between 2-10 centimeters\n* Meconium\n\nExclusion Criteria:\n\n* Major fetal anomaly\n* Multiple gestation\n* Eunice Kennedy Shrive National Institute of Child Health and Human Developmet (NICHD) Category III fetal heart tracing\n* Contraindication to internal monitors\n* Prelabor premature ruptuore of membranes before 36 weeks 0 days gestation, - Inability to consent","ALL","18 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nAlthough 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.\n\nThe 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:\n\nWarm lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion.\n\nThe 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.\n\nBy 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.",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Neonatal Respiratory Distress Related Conditions","Meconium","Perinatal Morbidity","Neonatal Acidosis","Cord Blood","Neonatal Brain Injury","Maternal Morbidity","Mechanical Ventilation","CPAP","Surfactant","Perinatal Death","Amnioinfusion","NICU Admission",[38,28,41,42,33,43,44,45],"Neonatal morbidity","Developmental Screening","Neonatal respiratory morbidity","Umbilical cord gas and biomarkers","Healthcare Utilization","RECRUITING","2026-05-15",{"date":49,"type":50},"2026-05-19","ACTUAL",{"date":47,"type":50},{"date":53,"type":21},"2030-04-15",{"name":55,"class":56},"Medical College of Wisconsin","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100599676","sleep-apnea-triggers-of-atrial-fibrillation-n-of-1-randomized-control-trial-sparta-100599676","NCT07087587","Sleep Apnea Triggers of Atrial Fibrillation: N-of-1 Randomized Control Trial (SPARTA):","SPARTA","Inclusion Criteria:\n\n1. Informed consent\n2. Age 18-85 years\n3. High burden paroxysmal AF (≥1%)\n4. Moderate-severe OSA (AHI ≥ 15)\n5. Implanted device with atrial diagnostics\n6. Enrolled in remote monitoring\n\nExclusion Criteria:\n\n1. AF ablation \\\u003C6 months\n2. Valvular abnormalities\n3. Excessive daytime sleepiness in safety-critical jobs\n4. Plans for ablation during study\n5. Non-CPAP OSA treatment\n6. Recent device implantation (\\\u003C6 months)\n7. Central sleep apnea","85 Years",{"count":67,"type":21},20,[24],"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).",[71,72,35],"Afib","Sleep Apnea Syndrome, Obstructive",[74,35,75],"OSA","AFIB","2026-04-09",{"date":78,"type":50},"2026-04-13",{"date":80,"type":50},"2025-08-25",{"date":82,"type":21},"2026-12-31",{"name":84,"class":56},"The Cleveland Clinic",2,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":85},"100571630","stroke-and-cpap-outcome-study-3-randomized-controlled-trial-100571630","NCT06722755","Stroke and CPAP Outcome Study 3 Randomized Controlled Trial","Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation","SCOUTS3","Inclusion criteria include:\n\n1. Age 18 years or older\n2. Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days\n3. Person providing consent (patient or legally authorized representative (LAR)) able to be consented in English or Spanish.\n\nExclusion criteria include:\n\n1. Unable to obtain informed consent from participant or LAR in English or Spanish\n2. Incarcerated\n3. Known pregnancy-determined by reviewing clinical data\n4. Current mechanical ventilation, tracheostomy, or supplemental oxygen use \\> 4L\u002Fmin\n5. Use of positive airway pressure within 14 days prior to stroke\n6. History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use\n7. Stroke related to tumors, vascular malformations or subarachnoid hemorrhage\n8. Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) including any benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the planned portable sleep apnea study\n9. Anticipated inpatient rehabilitation length of stay \\\u003C 5 nights\n10. Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team\n11. Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months\n12. Patients at significant risk of aspiration that could render the patient at risk of harm from use of CPAP, in the opinion of the site PI.",{"count":95,"type":21},250,[24],"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).\n\nThe 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.",[99,35,100],"Stroke Patients","OSA - Obstructive Sleep Apnea",[102,103,104,105,106],"behavioral therapy","continuous positive airway pressure","stroke recovery","self determination","sleep apnea","2026-03-25",{"date":109,"type":50},"2026-03-30",{"date":111,"type":50},"2025-01-15",{"date":113,"type":21},"2028-05",{"name":115,"class":56},"University of Washington",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":135,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":155,"leadSponsor":157,"locationsCount":57},"100583151","validating-a-novel-driving-simulation-based-mwt-against-the-standard-mwt-in-an-osa-cohort-challenged-by-cpap-withdrawal-100583151","NCT06872593","Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal","Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal - a Monocentric, Controlled, Randomized, Crossover Trial","DS-MWT2","Inclusion Criteria (OSA patients): adult drivers, diagnosed OSA, established CPAP-treatment regime, highly adherent and compliant within the last 6 months (\\>5h, \\>80% of days), at impaired eyesight with more than +\u002F- 5 diopter or astigmatism, contact lenses are required (for eye tracking)\n\nInclusion criteria (healthy comparison croup): adult drivers, no declared psychiatric disorders, no declared sleep-related diagnosis, at impaired eyesight with more than +\u002F- 5 diopter or astigmatism, contact lenses are required (for eye tracking)\n\nExclusion criteria (for both groups): sensibility to motion sickness (kinetosis, dizziness, etc. in 5 min screening drive), professional drivers (if working during the study period), inability to understand the study procedure for linguistic or cognitive reasons.",true,{"count":126,"type":21},54,[24],"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.\n\nExcessive 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\u002Fdrowsy 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).\n\nThere 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.\n\nA 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.\n\nWith 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.\n\nHowever, 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.",[130,131,132,133,134,35],"Excessive Daytime Sleepiness","Obstructive Sleep Apnea (OSA)","CPAP Treatment","Driving Simulator Performance","Driving Impaired",[136,137,138,139,140,141,142,143,144,145,146,147,148,149,150],"sleep","drowsy driving","sleepy driving","sleepiness behind the wheel","driving simulation","CPAP treatment","CPAP withdrawal","driving performance","sleep latency","maintenance of wakefulness test","MWT","microsleep","microsleep-like episodes","eye tracking","EEG-recording","2025-07-14",{"date":153,"type":50},"2025-07-17",{"date":151,"type":50},{"date":156,"type":21},"2027-04-30",{"name":158,"class":56},"Stefan Lakämper",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":57},"100581310","treatment-of-sleep-apnea-to-improve-metabolic-health-100581310","NCT06848647","Treatment of Sleep Apnea to Improve Metabolic Health","Treatment of Sleep Apnea to Improve Metabolic Health - a Novel Approach to Unanswered Questions","GLYCOSACT","Inclusion Criteria:\n\n* Patients diagnosed with obstructive sleep apnea\n* Planned for CPAP treatment\n* 18 years and above\n\nExclusion Criteria:\n\n* Patient not wanting to participate in study\n* Non-Swedish speaking\n* Judged by physician as non-fit for study participation",{"count":168,"type":21},600,"OBSERVATIONAL","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.",[172,173,35,174],"Sleep Apnea, Obstructive","Metabolism","Patients Above 18 Years","2025-02-26",{"date":177,"type":50},"2025-02-27",{"date":179,"type":50},"2024-05-13",{"date":181,"type":21},"2028-12-31",{"name":183,"class":56},"Uppsala University"]