[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autonomic-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autonomic-dysfunction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,47,72,104,138,176,203,231,258,284,345,373,396,440,480,501,524,546,570,600],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100630040","repetitive-transcranial-magnetic-stimulation-in-cardiac-autonomic-dysfunction-100630040",false,"NCT07482501","Repetitive Transcranial Magnetic Stimulation in Cardiac Autonomic Dysfunction","The Effect of Repetitive Transcranial Magnetic Stimulation on Cardiac Autonomic Dysfunction in Patients With Stroke","Inclusion Criteria:\n\n* Participants aged 35-80 years admitted to the Afyonkarahisar Health Sciences University Hospital Physical Medicine and Rehabilitation Unit for neurological rehabilitation after stroke\n* Participants with a history of stroke of at least 3 months\n* Neurologically and medically stable participants willing to participate regularly in the study\n* Participants capable of following commands\n\nExclusion Criteria:\n\n* Serious cardiac disease, uncontrolled hypertension\n* Epilepsy or history of antiepileptic drug use\n* Intracranial metallic implants\n* Inner ear implants\n* Malignancy\n* Active infection\n* Skin infection or open wound in the intervention area\n* Brain lesions or medications that may alter the seizure threshold\n* Increased intracranial pressure\n* Uncontrolled migraine\n* Fracture or surgery on the hemiplegic side within the last 6 months\n* Pregnancy","ALL","35 Years","80 Years",{"count":20,"type":21},44,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) added to conventional neurological rehabilitation on heart rate variability (HRV), quality of life, upper extremity muscle strength and autonomic symptoms in patients with stroke.",[27,28,29],"Stroke","Autonomic Dysfunction","Hemiparesis",[31,32,33],"Repetitive Transcranial Magnetic Stimulation","Hemiplegia","Neurological Rehabilitation","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":38},"2026-03-26",{"date":42,"type":21},"2026-11-15",{"name":44,"class":45},"Afyonkarahisar Health Sciences University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100628973","phase-4-cervicothoracic-sympathetic-block-evaluation-for-post-covid-condition-100628973","NCT07468604","Cervicothoracic Sympathetic Block Evaluation for Post COVID Condition","A Randomized Controlled Trial for Cervicothoracic Sympathetic Chain Block Against Sham Injection Evaluation for Post COVID Condition: the CeASE RCT","CeASE","Inclusion criteria\n\n1. Age 18 years or older\n2. PCC following COVID-19 infection with symptoms lasting for at least three months\n3. Ability to read, write, and understand English\n4. Quantified autonomic symptoms from at least one domain as reported by the patient on the screener Composite Autonomic Symptom Score (COMPASS-31), i.e. a COMPASS-31 score greater than 0. COMPASS-31 assesses 6 domains of autonomic symptoms: Orthostatic Intolerance, Vasomotor, Secretomotor, Gastrointestinal, Bladder, and Pupillomotor.\n5. Patients should be stable on any PCC-related medications for at least four weeks.\n\nExclusion criteria\n\n1. History of co-existing conditions that are a contraindication for SGBCSBCSB:\n\n   1. Unilateral vocal cord paralysis; Severe chronic obstructive pulmonary disease (FEV1 between 30-50% of predicted value)\n   2. Recent myocardial infarction (within the last one year), Cardiac conduction block of any degree\n   3. Glaucoma\n   4. Infection or mass at injection site, bleeding disorders\n2. Comorbid conditions that could confound study results, such as:\n\n   1. Active autoimmune disorders\n   2. Pre-existing autonomic dysfunction (e.g. POTS, IST, and CRPS) prior to COVID-19\n   3. Untreated psychiatric conditions (e.g. severe anxiety or PTSD requiring medication adjustments during the study period)\n3. Recent history of major surgery or cerebrovascular events within the last three months\n4. Allergy to local anesthetic; Inability to extend the neck for any reason (e.g. severe arthritis)\n5. History of prior stellate ganglion block","18 Years",{"count":57,"type":21},78,[59],"PHASE4","Post-COVID Condition (PCC) affects roughly 2.1 million Canadians, carrying an annual economic burden of CAD $7.8-50.6 billion. It presents across multiple organ systems with symptoms including fatigue, brain fog, palpitations, and orthostatic intolerance, at an annual cost of CAD $1,675-$7,340 per case.\n\nA key mechanism underlying many treatment-resistant PCC symptoms appears to be dysautonomia abnormal autonomic nervous system function driven by immune-mediated sympathetic overactivity. Persistent inflammation (cytokine storms, T\u002FB-cell dysfunction, microclots) sustains sympathetic hyperactivity, which in turn perpetuates systemic inflammation and \"sickness behaviors\" resembling PCC symptoms.\n\nCurrent treatments including beta blockers, ivabradine, fludrocortisone, and rehabilitation are limited by variable responses, side effects, and the complication of post-exertional symptom exacerbation. Emerging therapies (SSRIs, low-dose naltrexone, antihistamines, HBOT) show promise but lack robust trial evidence.\n\nCervicothoracic sympathetic chain block (CSB) a local anesthetic block of the cervical and upper thoracic sympathetic ganglia is a promising intervention that reduces sympathetic outflow, improves cerebral blood supply, and lowers pro-inflammatory cytokines. Small observational studies (16 studies, 224 patients) show benefit for PCC symptoms, but all lack placebo controls and have significant methodological heterogeneity.\n\nThe proposed study aims to fill this gap with a double-blind, placebo-controlled RCT to rigorously evaluate CSB's efficacy, magnitude of benefit, and durability in PCC patients.",[28],"2026-06-04",{"date":64,"type":38},"2026-06-08",{"date":66,"type":38},"2026-05-19",{"date":68,"type":21},"2027-09-01",{"name":70,"class":45},"University Health Network, Toronto",3,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":46},"100624417","non-invasive-vagus-nerve-stimulation-for-chronic-musculoskeletal-pain-100624417","NCT07409363","Non-invasive Vagus Nerve Stimulation for Chronic Musculoskeletal Pain","A Randomised, Single-blind, Sham-controlled, Crossover Pilot Study Assessing the Effect of Non-invasive Vagus Nerve Stimulation (nVNS) on Autonomic Symptoms and Pain Management in Patients With Chronic Musculoskeletal Pain and Autonomic Dysfunction","RESTORE-MSK","Inclusion Criteria:\n\n1. Individuals diagnosed with musculoskeletal (MSK) conditions and currently experiencing MSK pain lasting for 12 weeks or longer, in line with the ICD-11 criteria for chronic pain.\n2. Identified as having autonomic dysfunction (AD) defined as a score of 17 or more on the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire.\n3. Ability to understand and willingness to sign a written informed consent document.\n4. Stated willingness to comply with all study procedures and be available for the duration of the study (approximately 6 weeks).\n5. Ability to read and understand English sufficiently to complete study questionnaires.\n\nExclusion Criteria:\n\n1. Pregnancy (self-reported; safety of nVNS in pregnancy not established).\n2. Advanced heart disease, including: severe heart failure (NYHA Class III-IV), myocardial infarction within the preceding 6 months, or ongoing investigations for cardiac arrhythmias.\n3. Use of an active implantable medical device, including: cardiac pacemaker, implantable cardioverter-defibrillator (ICD), cochlear implant, hearing aid implant, or any other implanted electronic device.\n4. Concurrent use of another electrical stimulation device, including: transcutaneous electrical nerve stimulation (TENS) unit, muscle stimulator, or any other portable electronic stimulation device.\n5. Inability to provide informed consent.",{"count":81,"type":21},12,[24],"Chronic musculoskeletal (MSK) pain affects an estimated 20-33% of the global population and is frequently associated with autonomic nervous system dysfunction, characterised by symptoms such as orthostatic intolerance, palpitations, gastrointestinal dysmotility, and fatigue. Conventional treatments often fail to address this autonomic component, limiting their effectiveness. This pilot study investigates whether non-invasive vagus nerve stimulation (nVNS) using the gammaCore Sapphire device can reduce autonomic symptom severity and improve pain in adults with chronic MSK pain and confirmed autonomic dysfunction.\n\nRESTORE-MSK is a randomised, single-blind, sham-controlled, crossover pilot study. Twelve participants with chronic MSK pain (lasting 12 weeks or longer) and autonomic dysfunction (COMPASS-31 score of 17 or more) will be recruited from musculoskeletal clinics at Chapel Allerton Hospital, Leeds. Participants will be randomly allocated to receive either active nVNS or sham stimulation first, followed by a 2-week washout period, then crossover to the alternative treatment. Each treatment period lasts 14 days, with participants self-administering the device twice daily (morning and evening).\n\nThe primary outcome is change in autonomic symptom severity measured by the Composite Autonomic Symptom Score-31 (COMPASS-31). Secondary outcomes include physiological response to the NASA Lean Test, pain severity and interference (Brief Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L), intervention acceptability, and recruitment feasibility.\n\nThis pilot study aims to establish feasibility and proof of concept for a larger randomised controlled trial investigating nVNS as a non-pharmacological treatment option for chronic MSK pain with autonomic dysfunction.",[85,28,86],"Chronic Musculoskeletal Pain","Dysautonomia",[88,89,90,91,92,93],"Vagus Nerve Stimulation","Non-invasive Neuromodulation","Chronic Pain","Autonomic Nervous System","GammaCore","COMPASS-31","NOT_YET_RECRUITING","2026-05-06",{"date":97,"type":38},"2026-05-11",{"date":99,"type":21},"2026-05-14",{"date":101,"type":21},"2026-07-31",{"name":103,"class":45},"University of Leeds",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":123,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":46},"100605891","phase-4-landiolol-to-avoid-tachycardia-in-patients-at-risk-for-cardiovascular-events-undergoing-major-non-cardiac-surgery-100605891","NCT07168421","LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery","LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery: a Feasibility Trial","LANTA-P","Inclusion Criteria:\n\n* Patients undergoing elective non-cardiac surgery defined as intermediate or high-risk by the 2022 european society of cardiology (ESC) guidelines\n* surgery performed under general anesthesia;\n* expected length of hospital stay ≥ 24 hours;\n* age ≥ 45 years;\n* at least two of the following risk factors:\n\n  * age ≥ 75 years\n  * arterial hypertension;\n  * ischemic heart disease (history of myocardial infarction or positive exercise test, current complaint of chest pain considered to be secondary to myocardial ischemia, use of nitrates, pathological Q waves, prior coronary revascularization);\n  * history of congestive heart failure;\n  * history of cerebrovascular disease;\n  * peripheral artery disease;\n  * diabetes mellitus;\n  * GFR ≤ 59 ml\u002Fmin pro 1.73 m2;\n  * pre-operative NTproBNP \\> 200 pg\u002Fml;\n* excessive sympathetic outflow as proven by exercise testing:\n\n  * impaired heart rate recovery (≤ 12 bpm within 1 minute after cessation of exercise); OR\n  * exaggerated heart rate response (≥ 12 bpm after 3 minutes of unloaded pedalling);\n\nExclusion Criteria:\n\n* unable to consent or follow study procedures;\n* absolute contraindications for exercise testing;\n* pregnancy or intention to become pregnant;\n* active cardiac conditions (such as unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease);\n* urgent \u002F emergency surgery;\n* already on β-blocker (within the last 30 days prior to recruitment);\n* contraindication for β-blocker therapy (bradycardia (HR \\\u003C 55 bpm), hypotension (systolic blood pressure \\\u003C 100 mmHg), severe peripheral vascular disease, severe asthma, allergy, higher-degree atrioventricular block);\n* severe preoperative anaemia (haemoglobin \\\u003C 100 g\u002FL) unless there is a plan set up and followed for correction prior to surgery;\n* planned intermediate care or intensive care admission;\n* prior enrolment in this trial.","45 Years",{"count":114,"type":21},114,[59],"Limiting perioperative tachycardia (aiming for a heart rate \\\u003C90 beats per minute throughout the perioperative period) using the ultra-short acting beta-blocker landiolol in patients with cardiovascular risk factors undergoing major surgery might lower the incidence of perioperative myocardial injury. Feasibility of the intervention needs to be proven prior to conduction of a larger trial.",[118,28,119,120,121,122],"Perioperative Myocardial Injury","Cardiovascular (CV) Risk","Major Surgery","Beta Blocker","Myocardial Injury After Non-cardiac Surgery",[124,125,126,127,128],"perioperative myocardial injury","major surgery","beta blocker","myocardial injury after non-cardiac surgery","autonomic dysfunction","2026-05-04",{"date":131,"type":38},"2026-05-05",{"date":133,"type":38},"2026-04-24",{"date":135,"type":21},"2028-03-01",{"name":137,"class":45},"Insel Gruppe AG, University Hospital Bern",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":16,"minAge":55,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":46},"100611275","phase-3-exploring-sympathetic-nervous-system-function-in-individuals-with-down-syndrome-100611275","NCT07238465","Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome","Dysautonomia InVestigation in Individuals With Down SyndromE: DIVE Study","DIVE","Inclusion Criteria:\n\n* 18-50 yrs old and apparently healthy individuals\n* Ability to understand the study and give assent to participate\n* Has a study partner who can attend all visits for the individuals with DS, and answer questionnaires, provide consent when necessary\n* Corrected or non-existent congenital heart disease\n* Euthyroid or on stable thyroid medication dose for at least 6 months\n* Free from cardiovascular, pulmonary, inflammatory, or metabolic disease in the past 6 months that would prevent participation in study procedures\n* BMI \\\u003C45kg\u002Fm2\n* Ability to tolerate repeated blood draws \u002F catheter placement\n\nExclusion Criteria:\n\n* Hypertension (resting systolic blood pressure \\[SBP\\] ≥140 and\u002For diastolic blood pressure \\[DBP\\] ≥90 mmHg) this includes those on medications to treat hypertension\n* Hypotension (resting BP of \\\u003C90\u002F60 mmHg)\n* Cancer in the last six months\n* Any heart-rate-altering medications or any other medication that may modify metabolic responses\n* Self-reported diabetes or use of glucose-lowering medication\n* Tobacco products, including vaping, or marijuana use\n* Currently pregnant\n* Post-menopausal women\n\nSpecific Exclusion Criteria for Certain Stressors:\n\n* Orthopedic limitations that would prohibit exercise or movement for exercise\n* Fracture of limb to be immersed for CPT\n* Open cut or sore on hand to be immersed for CPT\n* Raynaud's syndrome for CPT\n* Chronic caffeine drinkers for caffeine stressor (consumption of caffeine in the last 7 days)",true,"50 Years",{"count":149,"type":21},200,[151],"PHASE3","Down syndrome (DS), the most common genetic cause of intellectual disability, is associated with widespread organ dysfunction, including abnormalities in the autonomic nervous system (ANS). The ANS regulates critical functions such as heart rate (HR) and blood pressure (BP), both essential for maintaining homeostasis and supporting physical activity. Individuals with DS often exhibit blunted HR responses to exercise-typically \\~30 beats per minute below expected levels-suggesting reduced sympathetic nervous system (SNS) activity. The SNS governs rapid changes in HR and BP during stress by releasing catecholamines: epinephrine (from the adrenal medulla) and norepinephrine (from sympathetic nerve endings). Despite its importance, SNS function has not been comprehensively assessed among individuals with DS.\n\nThis study addresses a critical knowledge gap by evaluating SNS responses to physiological stressors in individuals with DS. The investigators will measure beat-to-beat HR and BP, along with plasma catecholamine levels, in response to sympathetic activation, comparing individuals with DS to age- and sex-matched controls. Understanding the mechanisms of SNS dysfunction in DS is vital, as it likely underlies reduced exercise capacity and contributes to broader clinical challenges. These insights may guide targeted interventions to improve cardiovascular function, physical capacity, and overall quality of life in this understudied population.",[154,28],"Down Syndrome",[156,157,158,159,160,161,162,163,164,165,166,167],"Cold Stress","Pain Responses","Fear","Exercise","Blood Pressure","Heart Rate","Caffeine","12-Hour Fast","Catecholamines","Epinephrine","Norepinephrine","Dopamine","2026-04-28",{"date":129,"type":38},{"date":171,"type":38},"2026-04-06",{"date":173,"type":21},"2029-12",{"name":175,"class":45},"University of Colorado, Denver",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100514349","continuous-and-non-invasive-measurements-by-task-force-corecardio-in-autonomic-function-testing-aft-100514349","NCT05977335","Continuous and Non-invasive Measurements by Task Force® CORE\u002FCARDIO in Autonomic Function Testing (AFT)","Inclusion Criteria:\n\n* Adult patients (patients aged ≥ 18 years)\n* Patients giving written informed consent to participate in the study.\n* Patients with intact perfusion of both hands evidenced by a positive Allen's test.\n* Patients with orthostatic intolerance will be included\n\nExclusion Criteria:\n\n* Patients with vascular implants at the sites of non-invasive BP measurement (fingers or upper arms)\n* Very low perfusion in the periphery\n* Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (PAOD))\n* Patients with significant edema in the fingers\n* Patients with atrial fibrillation\n* Patients with valvular disease of grade 2 or above\n* Patients with ventricular assist devices\n* Subjects not passing the Allen's test for both hands.\n* Patients with a large lateral difference in BP (\\> 15 mmHg for systolic BP and\u002For \\>10 mmHg for diastolic BP) or with same arm measurement differences \\> 10 mmHg in systolic or diastolic BP during assessment of lateral differences",{"count":183,"type":21},75,"OBSERVATIONAL","Background: The investigational device, \"Task Force® CORE\" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the \"Task Force® CARDIO\" (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAP® (continuous non-invasive arterial pressure) technology by CNSystems.\n\nAim: The primary aim of this prospective, method comparison, open study is data acquisition for the performance evaluation of the TFC during autonomic function testing in comparison with an clinically accepted reference method. Setting: The setting of the clinical investigation will be the autonomic function testing laboratory at the Department of Neurology, the University Hospital Center Zagreb.\n\nInclusion criteria: Patients who are over 18 years and who provide written informed consent.\n\nSample size: The study has an calculated sample size of 70 patients. Considering a drop-out rate of 5%, a total of 75 patients will be included.\n\nStatistics: Descriptive statistics, values for the percentage error and correlation estimates will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of parameter changes and further comparative statistics will be performed.",[28,187],"Orthostatic Intolerance",[160,189,190,191,192],"Hemodynamics","Non-invasive","Continuous","Autonomic Function Testing","2026-03-16",{"date":195,"type":38},"2026-03-18",{"date":197,"type":21},"2026-11-01",{"date":199,"type":21},"2027-12-01",{"name":201,"class":202},"CNSystems Medizintechnik GmbH","INDUSTRY",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":146,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":46},"100630037","autonomic-regulation-of-blood-pressure-and-heart-rate-during-orthostasis-and-exercise-in-healthy-and-hypertensive-individuals-100630037","NCT07482462","Autonomic Regulation of Blood Pressure and Heart Rate During Orthostasis and Exercise in Healthy and Hypertensive Individuals","Assessment of Autonomic Regulation of Blood Pressure and Heart Rate in Healthy and Hypertensive Individuals During Orthostasis and Physical Exercise","Inclusion Criteria:\n\n* Healthy volunteers aged 18-35 years without known acute or chronic disease, non-smokers, body mass index (BMI) 20-24.9 kg\u002Fm², and negative orthostatic test\n* Participants aged ≥60 years with arterial hypertension followed at the Department of Hypertension\n* Hypertension group: controlled arterial hypertension, negative orthostatic test, without diabetes mellitus\n* Hypertension with orthostatic hypotension group: controlled arterial hypertension and positive orthostatic test indicating orthostatic hypotension\n* Hypertension with orthostatic hypertension group: controlled arterial hypertension and positive orthostatic test indicating a rise in blood pressure during orthostatic testing\n* Hypertension with diabetes mellitus group: controlled arterial hypertension and diabetes mellitus without previously diagnosed autonomic dysfunction\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Dementia, neurodegenerative disease, or cognitive impairment preventing understanding of study procedures\n* Known cardiovascular disease including heart failure (NYHA II-IV), myocardial infarction within the previous 6 months, clinically significant arrhythmias, or peripheral arterial occlusive disease\n* Uncontrolled arterial hypertension\n* Change in antihypertensive therapy within the previous 4 weeks\n* Presence of a cardiac pacemaker\n* Treatment with antiarrhythmic drugs (class I, III, or IV), digoxin, alpha-receptor blockers, or other medications known to significantly affect heart rate variability or autonomic function\n* Advanced renal failure (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²) or advanced liver failure\n* Active malignancy\n* Body mass index ≥35 kg\u002Fm²\n* Acute illness within the previous 4 weeks\n* Current smoking\n* Inability to safely perform exercise testing on a cycle ergometer\n* Severe psychiatric disorders without stable treatment\n* Pregnancy or breastfeeding\n* Participation in another clinical study\n* Refusal or inability to provide written informed consent",{"count":211,"type":21},120,"The goal of this observational study is to assess arterial stiffness and autonomic regulation of blood pressure and heart rate in healthy adults and people with arterial hypertension during orthostatic stress and graded physical exercise. The main objective is to analyze cardiovascular responses to exercise on a cycle ergometer in different subgroups of participants with hypertension.\n\nThe study includes healthy young adults and older adults with hypertension. Participants undergo standardized assessments including orthostatic testing, graded exercise testing on a cycle ergometer, electrocardiography, and measurement of arterial stiffness parameters such as pulse wave velocity, as well as other vascular and hemodynamic parameters.\n\nThe results of this study are expected to improve understanding of cardiovascular physiology and autonomic regulation in people with hypertension and may contribute to earlier recognition of autonomic dysfunction and improved clinical management.",[214,28,215],"Hypertension","Orthostatic Hypotension",[217,218,219,220,221],"Orthostatic Test","Arterial Stiffness","Exercise Testing","Heart Rate Variability","Pulse Wave Velocity","2026-03-14",{"date":224,"type":38},"2026-03-19",{"date":226,"type":38},"2025-10-15",{"date":228,"type":21},"2027-03",{"name":230,"class":45},"University Medical Centre Ljubljana",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":46},"100561259","noninvasive-spinal-cord-stimulation-for-early-sci-100561259","NCT06587841","Noninvasive Spinal Cord Stimulation for Early SCI","Noninvasive Spinal Cord Neuromodulation to Improve Lower Urinary Tract Function After Spinal Cord Injury in Ukrainian War Veterans","Inclusion Criteria:\n\n* A participant must meet all of the following criteria in order to be eligible to participate:\n\n  1. Be a resident of either British Columbia (for Vancouver Site) with an active provincial medical service plan or Ukraine (for Ukraine Site) Age between 19 and 65 years at the time of consent\n  2. Subacute (time since injury 3-6 months) or chronic (time since injury 12+ months) SCI\n  3. ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10\n  4. Documented impaired LUT function\n  5. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:\n\n     i. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.\n\n     ii. Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.\n  6. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.\n  7. Must provide informed consent.\n  8. Agrees to comply with all planned visits and assessments, adhere with established bowel and LUT routines and refrain from initiation of new medications for bowel and LUT management without notifying the Principal Investigator of this study.\n\n     Exclusion Criteria:\n* A participant who meets any of the following criteria will be ineligible to participate:\n\n  1. Clinically significant depression with thoughts of suicidal ideation (PHQ-9 total score above 20) or debilitating PTSD (PCL-5 total score above) or as judged by the investigator.\n  2. History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.\n  3. Exhibits signs of lower motor neuron injury (i.e., concomitant conus medullaris\u002Fcauda equina injury).\n  4. History of intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline visit.\n  5. Concurrent use of any medication or treatment that in the opinion of the investigator interferes with study outcomes.\n  6. Presence of cognitive impairments, social\u002Fpsychological problems, or other comorbid conditions that, in the opinion of the Investigator, will preclude them from participation and completion of the study\n  7. Presence of severe acute medical issues that interfere with testing (e.g., stage 3\u002F4 pressure ulcers, uncontrolled diabetes).\n  8. Contraindications for TSCS, such as:\n\n     8.1. Implanted Cardiac pacemaker 8.2 Implanted metal in the trunk or spinal cord 8.3 Intrathecal delivery system (e.g., baclofen pump) 8.4 Implanted central or peripheral neuromodulator\n  9. Medical condition that may put the participant at risk as determined by the investigator.\n  10. Participation in or plans to participate in another research study that may interfere with the study endpoints.","19 Years","65 Years",{"count":241,"type":21},60,[24],"The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute and chronic SCI (time since injury 3-6 months) and the impact on quality of life. The study will be conducted at two sites; site 1 in Canada and site 2 in the Ukraine. Up to 60 subjects will be enrolled; 10 adults at the ICORD, University of British Columbia (UBC), Vancouver, Canada site and 50 adults at the Rivne Regional War Veterans Hospital, Rivne, Ukraine. Eligible participants will be randomized (1:1 ratio) either to Group 1 (G1) or Group 2 (G2). G1 will receive therapeutic TSCS for 8 weeks (3 times per week; 1 hour per session) in conjunction with conventional rehabilitation (3-4 hours per day; 5 days per week). G2 will receive 8 weeks of sham stimulation in conjunction with conventional rehabilitation. After 8 weeks, G2 will cross over and receive therapeutic TSCS for 8 weeks, whereas G1 will continue to receive TSCS therapy for another 8 weeks, for a total of 16 weeks. Eligible participants enrolled into the study will attend fifty eight (58) visits for assessments, therapy, and follow-up. The expected duration of study participation for each participant will be 33 weeks.",[245,246,247,28,248],"Spinal Cord Injuries","Bowel Dysfunction","Sexual Dysfunction","Urologic Disorders","2026-02-23",{"date":251,"type":38},"2026-02-27",{"date":253,"type":38},"2024-10-01",{"date":255,"type":21},"2027-10-01",{"name":257,"class":45},"University of British Columbia",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":146,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":46},"100518185","long-covid-immune-profiling-100518185","NCT06027255","Long COVID Immune Profiling","Inclusion Criteria:\n\n* Subjects will be 18 years or older, men and women.\n* History of confirmed COVID-19 infection (positive contact and symptoms, antigen test or PCR).\n* POTS will be defined as the presence of orthostatic tachycardia (\\>30 bpm) and chronic (\\>3 months) pre-syncopal symptoms.\n* Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (\\>30 bpm) and chronic (\\>3 months) pre-syncopal symptoms. Symptoms occurred within 2 months after COVID infection and persistent until enrollment in the study.\n\nExclusion Criteria:\n\n* Individuals with a history of physician diagnosed myocardial infarction, angina, heart failure, stroke, or transient ischemic attack, or who had undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries).\n* Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.\n* Chronic use of steroids, anti-IL6 (omalizumab), anti-TNF-alpha, other immunosuppressants.\n* Chronic use of NSAID. Should not enroll if taking without one week prior to blood sampling.\n* Treatment with plasmapheresis, IVIG or other immune modulator",{"count":265,"type":21},150,[24],"Parasympathetic nervous system (PNS) is part of the body's autonomic nervous system(PNS) protects body against inflammation. Study shows that reduced PNS function activity is associated with persistent inflammation.\n\nPreliminary data from the studies shows, that post-COVID-19 POTS patients have reduced parasympathetic (PNS) function. Given that the PNS protects against inflammation, this clinical trial aims to prove that post-COVID-19 POTS is caused by reduced PNS activity, which in turn, contributes to persistent inflammation, orthostatic intolerance, and OI symptoms.\n\nThe study will evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity.",[269,270,28],"Long COVID","POTS - Postural Orthostatic Tachycardia Syndrome",[272,273,187,269,274],"SARS-CoV-2 infection","POTS","Long hauler COVID infection","2025-12-07",{"date":277,"type":38},"2025-12-15",{"date":279,"type":38},"2024-04-24",{"date":281,"type":21},"2027-07-01",{"name":283,"class":45},"Vanderbilt University Medical Center",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":146,"sex":16,"minAge":292,"maxAge":55,"enrollmentInfo":293,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":295,"conditions":296,"keywords":313,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":46},"100420250","pediatric-hypertension-and-the-renin-angiotensin-system-phrase-100420250","NCT04752293","Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)","Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE): The Role of Angiotensin-(1-7) in Hypertension and Hypertension-Induced Heart and Kidney Damage","PHRASE","INCLUSION CRITERIA: HYPERTENSION COHORT\n\n* 7-18 years of age at time of enrollment\n* Confirmed new diagnosis of primary hypertension: no identifiable secondary cause, referred to hypertension or nephrology clinic\n\n  * Age \\\u003C13 years: BP ≥95th %ile or ≥130\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP ≥130\u002F80 mmHg\n* Participants and their caregivers must be willing and able to commit to completing the study assessments\n\nEXCLUSION CRITERIA: HYPERTENSION COHORT\n\n* \\\u003C7 years or \\>18 years of age at time of enrollment\n* BP confirmed as normal or in the elevated BP category based on ≥3 prior office BP measurements on separate days;\n\n  * Age \\\u003C13 years: BP \\\u003C95th %ile or \\\u003C130\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP \\\u003C130\u002F80 mmHg\n* A confirmed secondary cause of hypertension\n* Confounding medical condition (heart or kidney disease \\[except hypertension-associated heart changes on echocardiogram or albuminuria\\], vascular\u002Finflammatory disease, or diabetes)\n* Inability to complete study assessments\n* Non-English\u002FSpanish speakers\n* Current pregnancy\n* Ward of the State\n\nINCLUSION CRITERIA: CONTROL COHORT\n\n* 7-18 years of age at time of enrollment\n* Normal BP based on ≥3 prior office BP measurements on separate days;\n\n  * Age \\\u003C13 years: BP \\\u003C90th %ile or \\\u003C120\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP \\\u003C120\u002F80 mmHg\n* Participants and their caregivers must be willing and able to commit to completing the study assessments\n\nEXCLUSION CRITERIA: CONTROL COHORT\n\n* \\\u003C7 or \\>18 years of age at time of enrollment\n* Elevated BP or hypertension, based on ≥3 prior office BP measurements on separate days:\n\n  * Age \\\u003C13 years: BP ≥90th %ile or ≥120\u002F80 mmHg (whichever is lower)\n  * Age ≥13 years: BP ≥120\u002F80 mmHg\n* History of elevated BP or hypertension\n* Current use of BP-lowering medications\n* Confounding medical condition (heart or kidney disease, vascular\u002Finflammatory disease, or diabetes)\n* Inability to complete study assessments\n* Non-English\u002FSpanish speakers\n* Current pregnancy\n* Ward of the State","7 Years",{"count":294,"type":21},125,"Studying the causal roles of components of the renin-angiotensin-aldosterone system (including angiotensin-(1-7) (Ang-(1-7)), angiotensin-converting enzyme 2 (ACE2), Ang II, and ACE), uric acid, and klotho in pediatric hypertension and related target organ injury, including in the heart, kidneys, vasculature, and brain. Recruiting children with a new hypertension diagnosis over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist and Atrium Health Levine Children's Hospital. Healthy control participants will be recruited from local general primary care practices. Collecting blood and urine samples to analyze components of the renin-angiotensin-aldosterone system (Ang-(1-7), ACE2, Ang II, ACE), uric acid, and klotho, and measuring blood pressure, heart structure and function, autonomic function, vascular function, and kidney function at baseline, year 1, and year 2. Objectives are to investigate phenotypic and treatment response variability and to causally infer if Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho contribute to target organ injury due to hypertension.",[214,297,298,299,300,301,302,303,304,305,306,307,28,308,309,310,311,312],"Left Ventricular Hypertrophy","Left Ventricular Dysfunction","Left Atrial Dilatation","Left Ventricular Diastolic Dysfunction","Kidney Diseases","Kidney Injury","Kidney Dysfunction","Sodium Urine High","Blood Pressure Disorders","Uric Acid Retention","Angiotensin Hypertension","Autonomic Imbalance","Pediatric Kidney Disease","Pediatric Obesity","Proteinuria","Albuminuria",[314,315,214,316,317,297,312,318,319,320,321,322,323,324,325,326,327,328,329,330,300,302,220,331,310,332,333,334,335],"High Blood Pressure","Elevated Blood Pressure","Pediatric Hypertension","Target Organ Damage","Uric Acid","Klotho","Fibroblast Growth Factor 23","Renin-Angiotensin-Aldosterone System","Renin-Angiotensin System","Angiotensin-(1-7)","Angiotensin II","Angiotensin-Converting Enzyme 2","Angiotensin-Converting Enzyme","Causal Inference","Causal Mediation Analysis","Sensitivity Analysis","Predictive Analysis","Sodium","Lifecourse","Kidney Function","Ambulatory Blood Pressure Monitoring","Echocardiogram","2025-12-04",{"date":338,"type":38},"2025-12-11",{"date":340,"type":38},"2021-05-19",{"date":342,"type":21},"2026-12",{"name":344,"class":45},"Wake Forest University Health Sciences",{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":16,"minAge":238,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":362,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},"100467649","non-invasive-spinal-cord-stimulation-for-recovery-of-autonomic-function-after-spinal-cord-injury-100467649","NCT05369520","Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury","Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice","Inclusion Criteria:\n\n1. Resident of British Columbia, Canada with active provincial medical services plan.\n2. Male or female, 19-60 years of age.\n3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.\n4. \\>1-year post injury, at least 6 months from any spinal surgery.\n5. American Spinal Injury Association Impairment Scale (AIS) A, B.\n6. Stable management of spinal cord related clinical issues (i.e., spasticity management).\n7. Experience bladder, or bowel, or sexual dysfunction.\n8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.\n9. For women of childbearing potential, not intending to become pregnant, currently pregnant, or lactating. The following conditions apply:\n\n   1. A confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.\n   2. Use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.\n   3. If using combined hormonal contraception, a stable regimen during the period of the trial and for at least 28 days after completion of treatment.\n10. For sexually active males with female partners of childbearing potential, use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.\n11. Must provide informed consent.\n12. Willing and able to comply with all clinic visits and study-related procedures.\n13. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).\n\nExclusion Criteria:\n\n1. Ventilator dependent.\n2. Signs of lower motor neuron damage (i.e. concomitant conus medullaris\u002Fcauda equina injury).\n3. Severe anemia or hypovolemia as measured by hematocrit via blood test in the last six months.\n4. History of cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.\n5. History of seizures\u002Fepilepsy or recurring headaches.\n6. Clinically significant, unmanaged, depression (to be screened) or ongoing drug abuse.\n7. Intrathecal baclofen pump.\n8. Oral baclofen dose greater than 60mg.\n9. Individuals that have received intradetrusor or intrasphincter onabotulinumtoxinA injections within 6 months of baseline.\n10. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.\n11. Past electrode implantation surgery.\n12. Member of the investigational team or his\u002Fher immediate family.\n13. Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study.\n14. Known allergies or sensitivities to both blue dye and beetroot powder.\n15. Known or suspected gastrointestinal obstruction.\n16. Persons with active inflammatory bowel disease or a history of bowel perforation.","60 Years",{"count":354,"type":21},30,[24],"This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with spinal cord injury (SCI).",[358,28,247,359,360,361,215],"Spinal Cord Injury","Neurogenic Bladder Dysfunction","Neurogenic Bowel Dysfunction","Autonomic Dysreflexia",[363,358],"Neurostimulation","2025-12-01",{"date":366,"type":38},"2025-12-08",{"date":368,"type":38},"2023-10-03",{"date":370,"type":21},"2027-10",{"name":257,"class":45},2,{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":380,"minAge":55,"maxAge":239,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":46},"100613062","the-effects-of-inspiratory-muscle-training-female-patients-with-fibromyalgia-100613062","NCT07261696","The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia","The Effects of Inspiratory Muscle Training on the Autonomic Nervous System and Clinical Symptoms in Female Patients With Fibromyalgia","Inclusion Criteria:\n\n* Be aged between 18 and 65 years old,\n* Have been diagnosed with fibromyalgia according to the 2010\u002F2016 ACR criteria,\n* Be female,\n* Have moderate pain lasting at least 3 months and defined as at least 30 mm on the 0-100 mm visual analogue scale (VAS).\n\nExclusion Criteria:\n\n* Presence of chronic heart disease,\n* Current use of narcotic drugs,\n* History of asthma or other chronic respiratory diseases,\n* Pregnancy,\n* Diabetes, kidney, adrenal, pituitary or thyroid disorders,\n* History of serious neurological or psychiatric disorders (e.g. mania, psychosis, suicidal tendencies, bipolar disorder, schizophrenia, autism spectrum disorders),\n* Neurodegenerative diseases (e.g. Parkinson's, Alzheimer's, Huntington's disease),\n* Head trauma, migraine,\n* Presence of active cardiac implants.","FEMALE",{"count":382,"type":21},51,[24],"Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and psychological symptoms. Autonomic nervous system (ANS) dysfunction, marked by increased sympathetic and reduced parasympathetic activity, is considered one of its possible mechanisms. Although exercise is recommended in treatment, low motivation and fatigue often limit participation. Therefore, inspiratory muscle training (IMT), which targets the respiratory muscles, is seen as an easy-to-apply alternative.This randomized, controlled, double-blind study will be conducted at Niğde Ömer Halisdemir University Hospital. Fifty-one women aged 18-65 years who meet the 2010\u002F2016 ACR criteria for fibromyalgia will be randomly assigned to three groups: training (30% of maximal inspiratory pressure), sham (0-10%), and control (no training). ANS functions will be assessed using heart rate variability and the COMPASS-31 questionnaire. Pain, sleep quality, fatigue, anxiety, depression, and respiratory muscle strength will also be evaluated. Training will be performed with the Powerbreathe® device twice daily for six weeks.The study aims to investigate the effects of IMT on ANS functions in fibromyalgia and to explore its relationship with symptoms such as pain, fatigue, sleep disturbances, anxiety, and depression.",[386,28],"Fibromyalgia","2025-11-21",{"date":389,"type":38},"2025-12-03",{"date":391,"type":21},"2025-12-05",{"date":393,"type":21},"2026-12-05",{"name":395,"class":45},"Nigde Omer Halisdemir University",{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":404,"targetDuration":406,"studyType":184,"phases":4,"briefSummary":407,"conditions":408,"keywords":419,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":46},"100608041","polish-registry-of-cardioneuroablation-and-cardioneuromodulation-100608041","NCT07196397","POLish Registry of CArdioneuroablation and CArdioneuromodulation","POL-CA Registry: Multicenter Observational Study of Neuromodulatory Procedures in Cardiovascular Autonomic Dysfunction Syndromes","POL-CA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of at least one of the following conditions:\n\n  * Inappropriate sinus tachycardia (IST)\n  * Postural orthostatic tachycardia syndrome (POTS)\n  * Vasovagal syncope (VVS)\n  * Cardioinhibitory carotid sinus syndrome (CSS)\n  * Symptomatic sinus bradycardia or functional AV block\n  * Orthostatic hypotension (OH)\n* History of recurrent autonomic symptoms (e.g., syncope, bradycardia, palpitations, orthostatic intolerance)\n* Undergoing or previously underwent interventional treatment affecting cardiac autonomic innervation (e.g., cardioneuroablation, SN-sparing ablation, cardiac sympathetic denervation)\n* Provided written informed consent (for prospective arm)\n\nExclusion Criteria:\n\n* Structural heart disease requiring surgical intervention\n* Permanent pacemaker or ICD implanted prior to enrollment\n* Inability to complete follow-up assessments or questionnaires\n* Severe psychiatric comorbidities impairing participation\n* Participation in another interventional clinical trial",{"count":405,"type":21},1000,"3 Years","The multicentre observational study POL-CA involves a wide spectrum of patients with a history of syncopy. The study recruits patients with diagnosed vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or atrioventricular block, postural orthostatic tachycardia syndrome, orthostatic hypotension, and inappropriate sinus tachycardia syndrome. This is an observational, controlled study with retrospective, clinical data analysis of previously treated patients and the analysis of syncopal patients prospectively recruited into the study. The aim of the POL-CA registry is to create a platform for physicians to record treatment data for patients undergoing procedures that affect innervation or modify cardiovascular reflexes (cardioneuroablation, cardioneuromodulation) in order to provide a multicentre summary of population characteristics and treatment outcomes based on a standardized POL-CA questionnaire and methodology for various arrhythmias.",[409,410,411,412,215,413,414,415,416,417,28,418],"Vasovagal Syndrome VVS","Cardioinhibitory Carotid Sinus Syndrome CSS","Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV","Postural Orthostatic Tachycardia Syndrome POTS","Inappropriate Sinus Tachycardia Syndrome IST","Vasospastic Angina","Microvascular Angina","Ventricular Arrythmia","Raynaud Phenomena","Autonomic Diseases",[420,421,422,423,424,425,426,427,428,429],"cardioneuroablation","cardiac sympathetic denervation","sinoatrial node sparing hybrid ablation","catheter ablation","neural stimulation","cardioneuromodulation","percutaneus stellate ganglion blockage","cardiac rehabilitation","cardiovascular autonomic tests","syncope","2025-09-21",{"date":432,"type":38},"2025-09-29",{"date":434,"type":38},"2024-11-21",{"date":436,"type":21},"2031-12-31",{"name":438,"class":439},"SABAMED Medical Center Ltd.","NETWORK",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":146,"sex":16,"minAge":447,"maxAge":448,"enrollmentInfo":449,"targetDuration":4,"studyType":22,"phases":450,"briefSummary":451,"conditions":452,"keywords":459,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":46},"100548358","nightware-and-cardiovascular-health-in-veterans-with-ptsd-100548358","NCT06419959","NightWare and Cardiovascular Health in Veterans With PTSD","Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare","Inclusion Criteria:\n\n1. Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).\n2. Self-report having repetitive nightmares contributing to disrupted sleep;\n3. Age 22 years (rationale is because the device has only been used in adults in 22 years and older);\n4. Resting blood pressure (BP, \\\u003C160\u002F100 mmHg);\n5. Fasted glucose \\\u003C126 mg\u002FdL;\n6. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;\n7. Epworth Sleepiness Scale (ESS): Question #8 score above \"0\" will prompt an additional question: Do you drive (\"get behind the wheel\") when you are drowsy? The answer must be \"No\" to be enrolled in the study due to safety concerns;\n8. Wireless Internet and two power outlets in sleeping location;\n9. Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare;\n\nExclusion Criteria:\n\n1. Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer);\n2. Active infection (note, anyone with an active infection would become eligible once the infection has ended);\n3. Thyroid dysfunction, defined as an ultrasensitive TSH \\\u003C0.5 or \\>5.0 mU\u002FL; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study;\n4. Use of insulin or sulfonylureas\n5. Pregnancy or currently breast feeding;\n6. Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate;\n7. Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale \\[C-SSRS\\]).\n8. Shift workers (due to circadian rhythm disruption);\n9. Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy;\n10. Nocturia that causes awakening from sleep;\n11. Known sleep walking or acting out dreams (contraindication to NW use);\n12. Diagnosis or suspicion of dementia;\n13. Seizure disorder\n14. Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)","22 Years","88 Years",{"count":294,"type":21},[24],"The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.",[453,454,28,455,456,457,458],"Post-traumatic Stress Disorder (PTSD)","Cardiovascular Diseases","Vascular Stiffness","Nightmare","Endothelial Dysfunction","Veteran",[460,461,462,463,458,464,465,466,467,468,454,469],"Sleep","Oxidative stress","aging, inflammation","sex\u002Fgender","Trauma and Stressor Related Disorders","Mental Disorders","Nervous System Diseases","Autonomic Nervous System Diseases","Primary Dysautonomias","Stress Disorders, Post-Traumatic","2025-09-11",{"date":472,"type":38},"2025-09-12",{"date":474,"type":38},"2025-09-10",{"date":476,"type":21},"2026-12-31",{"name":478,"class":479},"VA Office of Research and Development","FED",{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":500},"100538329","autonomic-dysfunction-in-patients-following-bariatric-surgery-the-adipose-study-100538329","NCT06289413","Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study","Inclusion Criteria:\n\n* Between the age of 18 - 85 years\n* Can provide consent\n* Negative urine B-hCG\n* Continued follow-up with the bariatric surgery team.\n* BS includes one of the following: gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.\n* Phase I: Underwent BS within the last 3 years\n* Phase II: Will undergo BS within the next 3 months or underwent BS in the last 30 days\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Pregnant or breastfeeding\n* BMI \\\u003C 35\n* Revision surgery of one of the following BS from above\n* Prior history of autonomic dysfunction prior to BS\n* Developed AD 72 months post-procedure\n* No evidence of AD\u002FOI","85 Years",{"count":488,"type":21},400,"Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS.",[28,187],"2025-08-27",{"date":493,"type":38},"2025-08-28",{"date":495,"type":38},"2024-02-12",{"date":497,"type":21},"2025-12",{"name":499,"class":45},"Kansas City Heart Rhythm Research Foundation",8,{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":46},"100515304","interrogating-the-pathophysiological-mechanisms-of-constipation-in-patients-with-systemic-sclerosis-100515304","NCT05989763","Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis","TEA in SSc","Inclusion Criteria\n\n* Patients with SSc-constipation from Aim 1 of the study\n* Patients with SCT (\\>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)\n* Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA.\n\nExclusion Criteria\n\n-Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.",{"count":241,"type":21},[24],"The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.",[512,513,514,28],"Systemic Sclerosis","Constipation","Gastrointestinal Motility Disorder","2025-06-21",{"date":517,"type":38},"2025-06-26",{"date":519,"type":38},"2024-02-17",{"date":521,"type":21},"2029-09-01",{"name":523,"class":45},"The University of Texas Health Science Center, Houston",{"id":525,"slug":526,"hasResults":11,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":239,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":543,"locationsCount":545},"100540784","phase-4-efficacy-and-safety-of-vespireit-prolonged-release-tablets-in-patients-with-autonomic-dysfunction-syndrome-accompanied-by-functional-vertigo-100540784","NCT06321341","Efficacy and Safety of Vespireit, Prolonged-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo","Open-label, Multicenter, Randomized Controlled Phase 4 Trial Evaluating the Efficacy and Safety of Vespireit, Prolonged-release Tablets (Valenta Pharm JSC, Russia) Versus Arlevert, Tablets (Menarini International Operations Luxembourg S.A., Luxembourg) in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo.","Inclusion Criteria:\n\n1. Patient signed and dated the Informed Consent Form.\n2. Males and females ≥18 to ≤ 65 years of age inclusive at the time of signing the Informed Consent Form.\n3. Clinical diagnosis: G90.8 Other disorders of autonomic nervous system or G90.9 Disorder of autonomic nervous system, unspecified.\n4. Diagnosed chronic functional vertigo per Barani Society criteria: total DHI score ≥ 31 points; mean MVS score ≥ 1.5 points.\n5. For women of childbearing potential, a negative pregnancy test and consent to use an authorized method of contraception throughout the entire period of study participation, starting from Visit 0, and for 3 weeks after the end of the study; for men, consent to use an authorized method of contraception throughout the entire period of study participation and for 3 weeks after the end of the study.\n\nThe authorized contraceptive methods in this study are: intrauterine device, barrier method, or dual barrier method (condom or occlusive cap (diaphragm or cervical\u002Fvaginal cap) plus spermicide)). Hormonal contraception was not permitted due to insufficient data on drug interactions of buspirone.\n\nPostmenopausal women (≥2 years of amenorrhea) or women who are surgically sterile (hysterectomy, bilateral ovariectomy, tubal ligation)) and men with documented infertility or vasectomy will also be eligible for the study.\n\nNon-inclusion Criteria:\n\n1. Known or suspected hypersensitivity to the active substance or any of the excipients of the investigational drugs.\n2. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.\n3. A cumulative score \\> 2 on the Suicide Risk Assessment Scale (SRAS).\n4. Chronic heart failure III-IV functional classes according to the New York Heart Association (NYHA) classification, angina pectoris III-IV functional classes.\n5. Presence of uncompensated peripheral vestibular hyporeflexia due to previous vestibular neuronitis, labyrinthitis, labyrinth trauma.\n6. Presence at the time of screening of exacerbation of vestibular diseases with episodic vestibular syndrome.\n7. Meniere's disease.\n8. Established diagnosis of bilateral vestibular insufficiency.\n9. Syncopal and presyncopal conditions at the time of screening.\n10. Acute cardiovascular disease or surgical interventions (myocardial infarction, angioplasty, aortocoronary\u002Fmammary coronary heart bypass, unstable angina, and others) less than 6 months prior to the date of the Screening Visit.\n11. Acute cerebral circulatory disorders and\u002For transient ischemic attacks less than 6 months prior to the date of the Screening Visit.\n12. Hemodynamically significant cardiac rhythm and conduction abnormalities, including a history of cardiac rhythm and conduction abnormalities.\n13. An installed artificial pacemaker.\n14. Clinically significant ECG abnormalities;\n15. Established diagnosis of liver failure, including history and\u002For altered laboratory values: increase in aspartateaminotransferase (AST), alanineaminotransferase (ALT) more than 2.5 times relative to the upper limit of normal, increase in total bilirubin more than 1.5 times above the upper limit of normal;\n16. Established diagnosis of renal failure of any severity and\u002For creatinine clearance calculated by the Cockcroft-Gault formula at screening \\\u003C 80 ml\u002Fmin in women and \\\u003C 90 ml\u002Fmin in men.\n17. Pyloroduodenal obstruction based on history.\n18. Prostatic hyperplasia.\n19. Thyroid function disorder according to examination and clinical and laboratory tests.\n20. Parkinson's disease according to anamnesis.\n21. Severe ischemic heart disease.\n22. Uncontrolled hypertension with systolic blood pressure \\> 180 mm Hg and\u002For diastolic blood pressure \\> 110 mm Hg, or blood pressure (BP) at screening ≥140\u002F90 or ≤ 100\u002F60 mm Hg.\n23. Uncontrolled diabetes mellitus, diabetes mellitus in decompensation.\n24. Myasthenia gravis.\n25. Closed-angle glaucoma.\n26. Suspicion of elevated intraocular pressure at the time of screening.\n27. Systemic connective tissue diseases.\n28. Autoimmune diseases.\n29. History or suspected elevated intracranial pressure.\n30. Urinary retention due to a history of urethral and\u002For prostate disease.\n31. Need for surgical and\u002For endovascular treatment in the next 15 months.\n32. Epilepsy or convulsive seizures, including history of seizures.\n33. Alcoholism, drug dependence, substance abuse in the history and\u002For at the time of screening (alcoholism - use of more than 30 ml of ethyl alcohol per day during the last 6 months; drug dependence - use of any narcotic substances in any doses during the last 6 months; substance abuse - use of any psychoactive substances in any doses during the last 6 months).\n34. History of schizophrenia, schizoaffective disorder, bipolar disorder.\n35. Tuberculosis, hepatitis B and C, HIV infection, syphilis, history or by screening.\n36. Conditions after surgical procedures, if less than 6 months have passed since the intervention.\n37. Therapy for cognitive impairment, balance disorders, and dizziness 21 days or less prior to Visit 1-1 date.\n38. Use of an irreversible MAO inhibitor within 14 days or a reversible MAO inhibitor within 1 day prior to Visit 1-1.\n39. Therapy with the following drugs and drug groups: 7 days or less before screening: Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SSRIs); Cinnarizine and\u002For dimenhydrinate preparations; Cytochrome P450 3A4 (Cytochrome P450 3A4, CYP3A4) inhibitors and inducers: Erythromycin, itraconazole, nefazodone, diltiazem, verapamil, etc.; Cimetidine, warfarin, phenytoin, propranolol. Monoamine oxidase inhibitors (MAOIs): concomitant use of MAO inhibitors is prohibited, as well as taking the drug earlier than 14 days after withdrawal of an irreversible MAO inhibitor, or less than 1 day after withdrawal of a reversible MAO inhibitor.\n40. Presence of a history of malignant neoplasm, except in patients who have had no disease in the past 5 years, patients with completely cured basal cell skin cancer, or completely cured carcinoma in situ.\n41. Decompensated somatic diseases that, in the opinion of the investigator, would prevent the patient from complying with the regimen prescribed by the study protocol, or would prevent assessment of the efficacy of therapy and compliance according to the protocol, or could skew the results of the study.\n42. Decompensated neuropsychiatric diseases, including multiple sclerosis, Parkinson's disease, endogenous depression, and others, which in the opinion of the investigator would prevent the patient from complying with the regimen prescribed by the study protocol, or would prevent assessment of therapy efficacy and compliance according to the protocol, or could skew the results of the study.\n43. Female patients who are pregnant or breastfeeding or planning pregnancy within the next 15 months.\n44. Patients requiring prohibited concomitant medications.\n45. Participation in another clinical trial within the last 3 months prior to the date of the Screening Visit.\n46. Patient's unwillingness or inability to comply with protocol procedures (in the opinion of the investigator).\n47. Other conditions that, in the judgment of the investigator, preclude the patient's inclusion in the study.\n48. The patient is diagnosed with COVID-19 disease at the time of screening or Randomization Visit; or the presence of symptoms of acute respiratory infections or COVID-19 within 14 days prior to screening and a positive rapid test for COVID-19 at screening.\n\nExclusion criteria:\n\n1. The patient's decision to discontinue participation in the study.\n2. A decision by the investigator that continued participation in the study is contrary to the patient's best interests.\n3. The patient is included in the study in violation of the inclusion and non-inclusion criteria.\n4. A decision by the investigator's physician to exclude the patient from the study due to lack of adequate cooperation of the patient with the investigator's physician during the study.\n5. Diagnosis of acute (vestibular neuronitis, acute labyrinthitis, traumatic vestibulopathy, stroke with lesions of central and peripheral vestibular structures and others) and\u002For episodic vestibular syndromes (benign positional paroxysmal vertigo, Meniere's disease, vestibular migraine and others), bilateral vestibulopathy.\n6. Skipping taking the study drug (3 consecutive tablets or more than 6 tablets for each period of therapy).\n7. Omission of the active comparator (9 consecutive tablets or more than 17 tablets per therapy period).\n8. An adverse event requiring withdrawal of investigational therapy or limiting protocol procedures.\n9. The need to prescribe to the patient drugs from the \"Prohibited Concomitant Therapies\" section.\n10. Loss of communication with the patient.\n11. Pregnancy.\n12. Ineffectiveness of therapy (increase from baseline or no decrease in DHI total score and MVS mean score by 25% or more from baseline after another course of therapy).\n13. The patient was diagnosed with COVID-19 disease during the periods of primary and repeated therapy.",{"count":532,"type":21},160,[59],"This study aims to evaluate the efficacy and safety of Vespireit, prolonged-release tablets, 15 mg (Valenta Pharm JSC, Russia) in comparison with Arlevert, tablets, 40 mg + 20 mg (Menarini International Operations Luxembourg S.A., Luxembourg) in patients with autonomic dysfunction syndrome accompanied by functional vertigo.",[536,28],"Vertigo","2025-06-11",{"date":539,"type":38},"2025-06-15",{"date":541,"type":38},"2024-01-24",{"date":476,"type":21},{"name":544,"class":202},"Valenta Pharm JSC",4,{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":146,"sex":380,"minAge":447,"maxAge":553,"enrollmentInfo":554,"targetDuration":4,"studyType":22,"phases":556,"briefSummary":557,"conditions":558,"keywords":561,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":372},"100594558","nightware-and-cardiovascular-health-in-women-with-ptsd-100594558","NCT07021014","NightWare and Cardiovascular Health in Women With PTSD","Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare","Inclusion Criteria:\n\n* Healthy, as determined by medical history\n* Group Specific Eligibility\n* PTSD Group\n* Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5)\n* Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)\n* Self-report having repetitive nightmares contributing to disrupted sleep\n* Poor overall sleep quality: PSQI score 6 or higher\n* Control Group\n* No lifetime PTSD: screened using PC-PTSD-5\n* No prior trauma exposure: screened using BTQ\n* Do not self-report having repetitive nightmares contributing to disturbed sleep\n\nExclusion Criteria:\n\n* Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes\n* Body Mass Index ≥ 40 kg\u002Fm2\n* Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1\u002FGIP RAs)\n* Active infection (note, anyone with an active infection would become eligible once the infection has ended)\n* Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine \\>1.3mg\u002FdL. Abnormal liver function tests within 1.5x ULN. UCH Clinical Lab ULN for AST and ALT are 39 and 52, respectively. Women with TSH levels outside of the normal range (0.5-5.0 mLU\u002FL) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized \\> 3 months\n* Plasma glucose \\>126 mg\u002Fdl under fasting conditions\n* Use of insulin or sulfonylureas\n* Pregnant, within 12 months postpartum or currently breast feeding\n* Current history of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate.\n* Report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the C-SSRS).\n* Shift workers\n* Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy\n* Nocturia that causes awakening from sleep\n* Epworth Sleepiness Scale: Question #8 score above \"0\" will prompt an additional question: Do you drive (\"get behind the wheel\") when you are drowsy? The answer must be \"No\" to be enrolled in the study due to safety concerns\n* Known sleep walking or acting out dreams (contraindication to NightWare use)\n* Diagnosis or suspicion of dementia\n* Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)\n* Current use of vitamin\u002Fsupplements (including melatonin) or anti-inflammatory medications, participants will be included if they are willing to stop taking vitamin\u002Fsupplements or anti-inflammatory medications 2 weeks prior to the first vascular visit.\n* Current or planned participation in an interventional study during the present study\n* Participants must have access to wireless internet and two power outlets where they sleep","40 Years",{"count":555,"type":21},36,[24],"The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.",[559,454,28,455,456,457,301,560,464],"Post Traumatic Stress Disorder","Renal Dysfunction",[460,464,559,454,301,560,28],"2025-06-05",{"date":564,"type":38},"2025-06-13",{"date":566,"type":21},"2025-07",{"date":568,"type":21},"2028-07",{"name":175,"class":45},{"id":571,"slug":572,"hasResults":11,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":11,"sex":16,"minAge":578,"maxAge":352,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":581,"conditions":582,"keywords":586,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":598,"locationsCount":545},"100358953","vns-prospective-neuromodulation-of-immune-and-gastrointestinal-systems-100358953","NCT03953768","VNS Prospective Neuromodulation of Immune and Gastrointestinal Systems","Prospective Non-randomized Single-arm Trial of Efferent Neuromodulation Immune and Gastrointestinal Systems by VNS in the Epilepsy Population","VNS-IG","Inclusion criteria:\n\n1. Undergoing VNS implantation for the first time as a treatment for epilepsy and\n2. Documented follow up with a Louisville-based neurologist in the past 1 year. If at the University of Utah or Baylor University documented ability to travel to their corresponding neurologist.\n3. Documented ability to travel to Louisville for outpatient medical care. If at the University of Utah or Baylor University documented ability to travel to their facilities.\n\nExclusion criteria:\n\n1. Previous treatment with VNS (other than the one implanted for this study)\n2. Current pregnancy (contraindication to surgery)\n3. Active infection\n4. History of cancer or treatment with chemotherapy\n5. History of autoimmune disease: Patients who received high effect anticholinergic medication within 30 days of enrollment will be excluded, whereas moderate to low effect anticholinergic medication will be discussed with and decided by the PI.\n6. If any high effect anticholinergic medication is started after enrollment, it will be the PI's decision to drop or postpone the corresponding visit or exclude the patient entirely.\n7. Patients who received high effect corticosteroids within 30 days of enrollment will be excluded, whereas moderate to low effect corticosteroids will be discussed with and decided by the PI.\n8. If any high effect corticosteroid is started after enrollment, it will be the PI's decision to drop or postpone the corresponding visit or exclude the patient entirely.\n9. Treatment with antiarrhythmic or (heart) rate controlling medication,\n10. Pre-existing cardiac arrhythmia or presence of cardiac pacemaker \u002F defibrillator","0 Years",{"count":354,"type":21},[24],"Vagal nerve stimulation is a neurosurgical procedure consisting of implantation of an impulse generator battery with leads placed into the vagus nerve in the neck. This procedure was FDA approved for epilepsy in the 1990s and is commonly performed as an outpatient surgery. The mechanism of action is not well understood; however it is increasingly recognized that electrical stimulation of the vagus nerve may impact other organ systems in the body including the immune and gastrointestinal systems. Concrete characterization of the peripheral effects of VNS in human gut microbiome and immune systems will: (1) elucidate peripheral mechanism of action of chronic VNS therapy, (2) identify peripheral preoperative biomarker of VNS efficacy, and (3) create a foundation for research investigating new GM and IM-related disease indications for VNS.\n\nThe primary objective of this study is to characterize the pre- and post-operative oral and gut microbiome of patients implanted with vagal nerve stimulator (VNS) for epilepsy. Secondary objectives of this study include: (1) to characterize the pre-operative and post-operative immune profile of patients undergoing VNS implantation for epilepsy, (2) to elucidate whether oral and\u002For gut microbiota changes are related to VNS efficacy for epilepsy and (3) identification of a biomarker predicting VNS efficacy.",[583,584,28,585],"Autoimmune Diseases","Epilepsy","Inflammatory Bowel Diseases",[587,588,589,590,591,592],"epilepsy","vagal","autoimmune","autonomic","inflammatory bowel disease","immune",{"date":594,"type":38},"2024-11-25",{"date":596,"type":38},"2021-04-01",{"date":476,"type":21},{"name":599,"class":45},"University of Louisville",{"id":601,"slug":602,"hasResults":11,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":380,"minAge":17,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":612,"conditions":613,"keywords":618,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":46},"100541915","metabolic-flexibility-and-autonomic-control-after-muscle-power-vs-metabolic-power-training-in-postmenopausal-oncological-women-the-power-health-study-100541915","NCT06336070","Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study","Postmenopausal Oncological Women Exercising for Recover Their Health. Associations and Changes in Metabolic Flexibility and Autonomic Control After Two Training Programs (Muscle Power vs Metabolic Power): the POWER Health Study","POWER Health","Inclusion Criteria:\n\n* Patients diagnosed of relapse free-cancer (RFC) or patients not diagnosed of any cancer at least the last 15 years (CG)\n* Aged between 35 and 75 years\n* Diagnostic of breast cancer (i.e., including ductal carcinoma, invasive carcinoma, triple negative; RFC) or physiological menopause (CG)\n* Not participating in a nutritional\u002Fdietary intervention\n* Not being physically active (i.e., not to be participating in any physical exercise program in the last 3 months, or performing less than 600 metabolic equivalents (METS)\u002Fweek of moderate-vigorous physical activity).\n* To be capable and willing to provide informed consent\n* Not to suffer from any specific condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise intervention (i.e., determined by the research staff).\n\nExclusion Criteria:\n\n* Medical contraindication for being engaged in an exercise.\n* Additional surgery planned within the intervention\n* Consuming usually betablocker or any drugs alterning nervous system functioning\n* History of another primary invasive cancer (RFC) or suffer a serious chronic illness (CG)\n* To present any of the following cardiac conditions: (i) myocardial infarction or coronary revascularization procedure within prior 3 months, (ii) uncontrolled hypertension (i.e., systolic ≥180 mmHg or diastolic ≥100 mmHg), (iii) uncontrolled arrhythmias (iv) valvular disease clinically significant, (v) decompensated heart failure or (vi) to suffer from known aortic aneurysm.","75 Years",{"count":610,"type":21},56,[24],"POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations.",[614,615,616,28,617],"Breast Cancer Female","Cardiometabolic Syndrome","Metabolism Disorder, Lipid","Cardiovascular Diseases in Old Age",[619,220,620,621,622,623,624,625,626,627,628,629],"Metabolic Flexibility","Muscle Power","Resting metabolic Rate","Lactate","High Intensity Interval Training","Strength Training","Breast Cancer","Ageing","Menopause","Female","Exercise Training","2024-04-02",{"date":632,"type":38},"2024-04-04",{"date":634,"type":38},"2024-01-01",{"date":636,"type":21},"2028-12-31",{"name":638,"class":45},"University of Valencia"]