[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"overlap-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:overlap-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,59,91,128,157],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100376320","impact-of-positive-airway-pressure-therapy-on-clinical-outcomes-in-older-veterans-with-chronic-obstructive-pulmonary-disease-and-comorbid-obstructive-sleep-apnea-overlap-syndrome-100376320",false,"NCT04179981","Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)","Inclusion Criteria:\n\n* OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (\\>10 pack-years) of smoking\n* Male or female gender\n* Age greater than or equal to 60 years\n* Stable treatment regimen for COPD\n\nExclusion Criteria:\n\n* Current or prior treatment with PAP or oral appliance\n* Central sleep apnea defined as central apnea index \\>5 per hour and comprising 50% of AHI\n* Known primary neuromuscular diseases\n* Disorders that may impact cognitive function including:\n\n  * neurodegenerative disorders\n  * traumatic brain injury\n* untreated PTSD and\u002For history of learning disability\n* Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results\n* Patient is actively suicidal due to depression, unstable mental health condition\n* Epworth sleepiness score \\>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months\n* Narcolepsy is the primary sleep disorder, with requirement of stimulant medications\n* Employed as a commercial driver or operating heavy machinery\n* On long-term oxygen therapy prior to start of study, more than 12 hr\u002Fday\n* Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia)\n* Consumption of \\>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits\n* Patients who cannot give informed consent\n* Patients receiving hospice care\n* Pregnant women due to unknown risks","ALL","60 Years",{"count":18,"type":19},668,"ESTIMATED","INTERVENTIONAL",[22],"NA","Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.",[25,26,27,28,29,30,31,32,33],"Sleep Apnea Syndrome","Obstructive Sleep Apnea","COPD","Overlap Syndrome","Quality of Life","Neurocognitive Function","Sleepiness","Elderly","Positive Airway Pressure",[35,36,37,38,39,40,41,42,43,44,45],"Apnea","Sleep Apnea Syndromes","Sleep Apnea, Obstructive","Nervous System Diseases","Respiration Disorders","Respiratory Tract Diseases","Signs and Symptoms, Respiratory","positive airway pressure","cognitive function","quality of life","sleepiness","RECRUITING","2026-06-03",{"date":49,"type":50},"2026-06-05","ACTUAL",{"date":52,"type":50},"2020-12-01",{"date":54,"type":19},"2027-12-31",{"name":56,"class":57},"VA Office of Research and Development","FED",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":15,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":20,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":58},"100457508","phase-2-the-cardiovascular-consequences-of-sleep-apnea-plus-copd-overlap-syndrome-100457508","NCT05237505","The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)","CRESCENDO-SLP","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Persons aged 40-79.\n* For women, only postmenopausal women will be included\n* Diagnosed with untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events\u002Fhr and ≤80 events\u002Fhr) and\u002For diagnosed with COPD with FEV1\u002FFVC ratio \\\u003C0.7 and will be on stable medications as assessed by a board-certified pulmonologist.\n\nExclusion Criteria:\n\n* Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation\n* Presence of specific devices: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices, metallic foreign bodies, implantable neurostimulation systems, cochlear implants\u002Fear implant, drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps), metallic fragments such as bullets, shotgun pellets, and metal shrapnel , cerebral artery aneurysm clips, magnetic dental implants, and artificial limb.\n* Known allergic reactions to components of the study intervention: (if getting contrast, MRI contrast (gadolinium)).\n* Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).\n* Exhibit Cheyne-Stokes respiration or central sleep apnea (\\> 25 % of events central)\n* Take potentially confounding medications or hormones that affect breathing.\n* Subjects will be excluded if they are deemed medically unstable with active neurological, cardiac, liver, endocrine, and infectious diseases.\n* We will also exclude participants with pulmonary disease apart from COPD.\n* We will exclude participants with active cancer treatment.\n* We will exclude azotemia (estimated glomerular fraction rate \\\u003C 30ml\u002Fmin) as there is some concern about giving gadolinium to these patients (if getting contrast MRI).\n* people with exposures deemed to be problematic for the research e.g. any smoking in bedroom by participant or household member, major second-hand smoke, e-cigarettes, tetrahydrocannabinol, major drug or alcohol consumption (\\>3 oz\u002Fday) and other environmental pollution effects (indoor and outdoor).\n* Individuals who are already on continuous O2 for COPD or PAP treatment for OSA.\n* Patients with sustained desaturations below 89% during wake time will be excluded for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care.\n* Individuals with OSA (AHI range 15-80\u002Fhr) will be screened for pathological sleepiness and will be excluded if ESS \\>18\u002F24, history of motor vehicle accident or near miss accident, or high-risk occupation.\n* COPD individuals with arterial PCO2 higher than 52 mmHg will be excluded.\n* Individuals who are currently incarcerated.","40 Years","79 Years",{"count":69,"type":19},240,[71],"PHASE2","Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown. OSA has been associated with major neurocognitive and cardiovascular sequelae, the latter likely a function of autonomic nervous system abnormalities, oxidative stress, inflammation, and other pathways. Recent data suggest that individuals with OVS die preferentially of cardiovascular disease compared to OSA or COPD alone, although mechanisms are again unclear.\n\nThe combination of OSA and COPD may lead to profound hypoxemia. Individuals with COPD can develop pulmonary hypertension via disturbances in gas exchange and parenchymal injury leading to loss of pulmonary vasculature. OSA has been associated with mild to moderate pulmonary hypertension, but the situation may be worse if combined with parenchymal lung disease. The biological response to sustained hypoxemia has been carefully studied as has the topic of intermittent hypoxemia; however, to our knowledge, very little research has occurred regarding the combination of sustained plus intermittent hypoxia as seen in OVS. For example, we do not really know whether individuals with OVS develop coronary disease, right or left heart failure, dysrhythmias or some combination of abnormalities predisposing them to cardiovascular death. Thus, design of interventional studies is challenging as causal pathways are poorly understood despite our considerable preliminary data addressing these issues.\n\nThe purpose of this study is to examine vascular mechanisms in individuals with COPD\u002FOSA overlap syndrome (OVS) compared with matched individuals with obstructive sleep apnea (OSA) alone or chronic obstructive pulmonary disease (COPD) alone and to perform a phase II pilot mechanistic clinical trial in OVS to examine the effect size of nocturnal bi-level positive airway pressure (PAP) vs. nocturnal oxygen therapy in cardiovascular outcomes.",[26,74,28],"Chronic Obstructive Pulmonary Disease",[76,77,27,78,79,80,81],"OSA","obstructive sleep apnea","chronic obstructive pulmonary disease","PAP therapy","oxygen","cardiovascular health","2026-06-01",{"date":47,"type":50},{"date":85,"type":50},"2024-02-13",{"date":87,"type":19},"2028-08-31",{"name":89,"class":90},"University of California, San Diego","OTHER",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":15,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":20,"phases":103,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":58},"100417093","phase-1-lyell-syndrome-mesenchymal-stromal-cells-treatment-100417093","NCT04711200","LYell SYndrome MEsenchymal Stromal Cells Treatment","Mesenchymal Stromal Cells Treatment in Lyell Syndrome: A Pilot Phase 1-2 Open Trial","LYSYME","Inclusion Criteria:\n\n* Patients ≥ 18 and ≤ 75 years-old\n* Admission ≤ 10 days after the index date (date of the first symptoms of the disease)\n* Patient with confirmed SJS-TEN diagnosis hospitalized in the department of Dermatology or intensive care medicine\n* At least 10 % of detachable-detached body surface area at any time during the first 10 days after the index date (date of the first symptoms of the disease)\n* Who, after the nature of the study has been explained to them or a support person (if applicable), and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* History of malignant disease within the past ten years and or presence of metastasis\n* Positive serology for HIV\n* Active infection for hepatitis B or C\n* Detection of Coronavirus SARS CoV-2 RNA on admission (positive RT-PCR), if performed in the usual care\n* Decompensated cardiac failure\n* Uncontrolled epilepsia\n* Previous history of allogenic bone marrow transplantation\n* Participation in other interventional drug research Patient deprived of liberty by a judicial or administrative decision or under the protection of justice\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the research protocol and follow-up schedule\n* Patient under tutorship or curatorship\n* Patient under psychiatric care according to art. L1121-6 CSP","18 Years","75 Years",{"count":102,"type":19},15,[104,71],"PHASE1","Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare severe cutaneous adverse reactions (SCARs) to drugs.\n\nTo date, no curative drug has demonstrated with a good level of evidence its ability to promote SJS and TEN healing and could contribute to earlier reepithelialisation. Mesenchymal stroma cells (MSCs) therapy represents a new therapeutic approach. eg, in patients with cardiovascular diseases, neurological diseases, renal transplantation, lung diseases as acute respiratory distress syndrome.\n\nRecently, MSCs have been proposed in both burn wound healing with a significantly decrease of the unhealed burn area and in cutaneous radiation.\n\nMoreover, MSCs have immunomodulation properties potentially effective in refractory acute and chronic graft versus host disease (GVHD) by improving thymic function and induction of Tregs. Indeed, MSCs are able to migrate to inflamed tissues after stimulation by pro-inflammatory cytokines and to modulate the local inflammatory reactions. MSCs have also demonstrated their ability to promote tissue remodelling, angiogenesis and immunomodulation through either differentiation or secretion of several growth factors such as VEGF, basic FGF and various cytokines.\n\nTherefore, combining their immunomodulation effect and secretion of soluble factors involved in wound repair, MSCs might be valuable as a cell therapy strategy for promoting cutaneous healing in SJS-TEN syndrome and subsequently decrease the morbi-mortality.",[107,108,109,28,110,111],"Epidermal Necrolysis","Lyell Syndrome","Toxic Epidermal Necrolysis","Mesenchymal Stromal Cells","Adipose Derived Stromal Cells",[113,114,115,116,117,118],"Epidermal necrolysis","Lyell syndrome","toxic epidermal necrolysis","Overlap syndrome","Mesenchymal stromal cells","Adipose derived stromal cells","2025-07-29",{"date":121,"type":50},"2025-08-01",{"date":123,"type":50},"2024-04-15",{"date":125,"type":19},"2027-04",{"name":127,"class":90},"Assistance Publique - Hôpitaux de Paris",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":15,"minAge":66,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":20,"phases":138,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":102},"100512908","impact-of-continuous-positive-airway-pressure-on-the-occurrence-of-acute-exacerbations-of-copd-in-patients-with-copd-osa-overlap-syndrome-co-os-100512908","NCT05958563","Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)","Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS) SLEEPOVEA","SLEEPOVEA","Inclusion Criteria:\n\n* 40 years of age or older\n* Grade of 2 or higher on the modified Medical Research Council scale (which ranges from 0 to 4, with higher grades indicating more severe dyspnea)\n* A post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 70% of the predicted value, and a postbronchodilator ratio of FEV1 to forced vital capacity (FVC) of less than 0.70.\n* Documented history of at least one moderate or severe COPD exacerbation during the previous year\n* Clinical suspicion of OSA (based on a STOP-bang questionnaire \\>3),\n* Have a telephone or a tablet or accept to use one during the study,\n* Willing and able to comply with all study procedures,\n* Subjects covered by or having the rights to medical care assurance.\n* An apnea-hypopnea index \\[AHI\\], ≥15 per hour based on a full night polysomnography and no significant central apneas (\\\u003C5 central apneas per hour of sleep\n\nExclusion Criteria:\n\n* Severe daytime sleepiness (Epworth sleepiness Scale \\>14\u002F24 and\u002For frequent sleepiness while driving or patient escaping a sleep-onset accident within the last 12 months),\n* Severe unstable cardiovascular disease (heart failure with FEVG≤45%, recurrent cardiac arrhythmia, instable coronary heart disease or stroke),\n* Patient on long-term oxygen therapy or non-invasive ventilation\n* Previously documented severe hypercapnia (PaCO2 ≥ 50mm Hg)\n* Previously diagnosed and treated OSA\n* Any rehabilitation program or any lung volume reduction procedure planned in the oncoming year\n* Pregnancy, breastfeeding\n* Bad understanding of the French language,\n* Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act",{"count":137,"type":19},500,[22],"Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends \"randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated\".",[141,142,28],"Sleep Apnea","COPD Exacerbation",[144,145,146],"sleep apnea","copd","overlap syndrome","2025-04-09",{"date":149,"type":50},"2025-04-13",{"date":151,"type":50},"2024-01-09",{"date":153,"type":19},"2028-01-01",{"name":155,"class":156},"University Hospital, Angers","OTHER_GOV",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":15,"minAge":99,"maxAge":4,"enrollmentInfo":164,"targetDuration":166,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":102},"100329484","canadian-network-for-autoimmune-liver-disease-100329484","NCT03569826","Canadian Network for Autoimmune Liver Disease","CaNAL","Inclusion Criteria:\n\n* Diagnosis of Primary Biliary Cholangitis and\u002For Autoimmune Hepatitis\n\nExclusion Criteria:\n\n* Less than 18 years of age",{"count":165,"type":19},2500,"6 Years","OBSERVATIONAL","CaNAL is a longitudinal observational cohort study of patients diagnosed with Primary Biliary Cholangitis (PBC), Autoimmune Hepatitis (AIH), or overlap syndrome. This study creates a nationwide registry and network focusing on high quality long-term follow-up of individual patient data from major Canadian centers.\n\nPrimary Biliary Cholangitis (PBC) and Autoimmune Hepatitis (AIH) are rare and slowly progressive liver diseases associated with development of cirrhosis, liver cancer (HCC) and liver failure requiring liver transplantation or leading to premature death. The rarity and slowly progressive nature of these autoimmune liver diseases make them difficult to study and only a large scale approach combining patient data from multiple centers across Canada will allow new insights. The primary aim of the Canadian Network for Autoimmune Liver Disease is to build a Canadian registry of patients with PBC, AIH, and overlap syndrome. We capture patient characteristics, laboratory assessments and natural history, patient-reported outcomes including quality of life measures and environmental exposures, response to treatment, and pre- and post-transplant outcomes. We will then identify risk factors associated with critical outcomes for the patient, including response to treatment, progression to transplant, risk of liver cancer, and recurrent disease after transplant. We can identify biomarkers (biochemical indicators of progression of disease) to help diagnose autoimmune liver disease at its earliest stages, ensuring timely treatment and preventing disease progression. CaNAL will provide a better understanding of autoimmune liver diseases, biomarkers predictive of disease progression or non-response to therapy as well as better knowledge of the etiology and pathogenesis. CaNAL will also help to serve as a platform for conducting clinical trials or targeted lab-studies to answer important questions that are unlikely to be evaluated by the pharmaceutical industry.",[170,171,28],"Primary Bilary Cirrhosis (PBC)","Autoimmune Hepatitis","2021-06-04",{"date":174,"type":50},"2021-06-07",{"date":176,"type":50},"2018-02-07",{"date":178,"type":19},"2028-12",{"name":180,"class":90},"University Health Network, Toronto"]