[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-rate-variability-hrv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-rate-variability-hrv":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,44,77,106,140,185,208,262,290,324,361],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100632836","heart-rate-variability-as-a-marker-for-titrating-high-flow-nasal-cannula-therapy-100632836",false,"NCT07518862","Heart Rate VAriability as a MaRker for tItrATing hIgh flOw Nasal Cannula Therapy","Heart Rate Variability as a Marker for Titrating High Flow Nasal Cannula Therapy in Patients With Respiratory Failure","VARIATION","Inclusion Criteria:\n\n* Age \\> 18\n* Currently receiving High-Flow Nasal Cannula Therapy\n\nExclusion Criteria:\n\n* FiO2 ≥ 90%\n* Pacemaker rhythm or presence of atrial fibrillation\n* Post-cardiac surgery patients\n* Contra-indications to electrical impedance tomography (EIT) and\u002For electrocardiogram (ECG) (active implantable medical device, burns, thoracic wounds limiting electrode placement)\n* Non-English-speaking","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","OBSERVATIONAL","High-flow nasal cannula is a type of non-invasive respiratory support that helps patients breathe more comfortably. Because the flow is high, it can deliver more oxygen to the lungs and make breathing easier by reducing the effort needed to breathe. However, the best strategy to determine the best oxygen flow rate remains uncertain. Reducing flow rates prematurely can increase work of breathing and prolong ICU stay, while unnecessary prolongation can increase costs. Currently, evidence to guide titration is limited.\n\nHeart rate variability is the natural variation in the time between each heartbeat. Heart rate variability reflects the level of autonomic nervous system activity in response to stress. The autonomic nervous system is the part of the nervous system that automatically controls how heart rate speeds up and slows down. When heart rate variability is higher, it indicates that the system is able to adjust to changes in the body, including stress. However, when heart rate variability is low, it indicates that the system is constrained and in a state of stress.\n\nThe VARIATION study is designed to characterize how heart rate variability goal of this observational study is to learn whether heart rate variability can serve as a marker of the appropriateness of high flow nasal cannula flow support during flow titration in patients with respiratory failure. The main question it aims to answer is:\n\nDoes heart rate variability change before other conventional respiratory signs when there are changes in respiratory function due to inadequate flow rate?\n\nParticipants already on high flow nasal cannula as part of their regular medical care will:\n\n1. Undergo a stepwise decrease in high flow nasal cannula flow rate.\n2. Be recorded continuously with electrocardiogram and electrical impedance tomography.",[25,26,27],"Respiratory Failure","Heart Rate Variability (HRV)","High Flow Nasal Cannula",[29,30],"Electrocardiogram (ECG)","Electrical Impedance Tomography (EIT)","RECRUITING","2026-06-16",{"date":34,"type":35},"2026-06-18","ACTUAL",{"date":37,"type":35},"2026-05-26",{"date":39,"type":21},"2026-12",{"name":41,"class":42},"University Health Network, Toronto","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100544195","effects-of-walking-in-greenspace-and-the-built-environment-in-adults-with-prediabetes-a-randomized-crossover-trial-100544195","NCT06365723","Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial","Inclusion Criteria:\n\n* 25-64 years old.\n* Classified as overweight or obese with BMI 20.0-39.9 kg\u002Fm2 per self-report and a BMI of 20.0- 41.9 kg\u002Fm2 upon actual measure.\n* Documentation\\* of a PreD diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg\u002FdL, a 2-hour oral glucose tolerance test of 140-199 mg\u002FdL, or an HbA1c level of 5.7%-6.49%271; OR a study screening lab value of HbA1C within the aforementioned range.\n* Currently engaged in ≤100 min\u002Fweek of moderate to vigorous exercise -confirmed via a 7-day activity recall.\n* No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) -this Questionnaire involves seven \"yes\" or \"no\" questions regarding an individual's health status. Answering \"yes\" to any one of these questions may require a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention. The participant would not be enrolled until this doctor's note is received.\n* Stable weight over the last 3 months (less than 10% change).\n* Not currently pregnant, planning to become pregnant, or currently breastfeeding.\n* Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.\n* Must own a smartphone and be willing and able to download the Garmin Connect app\n* Ability to speak and understand English.\n* Any level of income\n* Any race\u002Fethnicity\n\nExclusion Criteria:\n\n* Individuals \\\u003C25 or \\>64: younger individuals may have not yet reached physiological maturity and in whom PreD prevalence is low; older individuals are more likely to have contraindications to PA and other comorbidities.\n* BMI \\\u003C20 or ≥42.\n* Individuals with an HbA1c level \\\u003C5.7% or \\>6.4%.\n* Currently engaged in \\>100 min\u002Fwk of PA.\n* Individuals with contraindications to exercise participation as indicated by the PAR-Q.\n* A self-reported physical\u002Fmental disability that would prevent them from being able to adhere to the intervention.\n* Past or current diagnosis of Diabetes (Type 1, 1.5 or 2) or use of diabetic medications (e.g. medications to control blood sugar)\n* Any history of a cardiovascular disease event (e.g. heart attack, ablation, pacemaker, stroke)\n* Current treatment for cancer or heart disease (lipid and hypertensive medications acceptable but will be tracked closely).\n* Any change within the last 3 months, or anticipated changes, of any medications that would affect study outcomes (e.g. medications for lipids, blood pressure, anxiety, depression)\n* The use of any medication that significantly interferes with the autonomic nervous system\n* Current tobacco or nicotine users, or those who have quit within the last six months\n* Excessive alcohol (on average\\>1 drinks\u002Fday for women and \\>2 drinks\u002Fday for men) or excessive recreational drug use (reported usage of once a week or more).\n* Unstable weight over the last three months (\\>10% change).\n* Those with major surgery planned or recent history of bariatric surgery (within last 2 years) or a history of other medical interventions that would interfere with study outcomes\n* Currently within one-year postpartum, currently pregnant, or planning to become pregnant during the study period.\n* Currently breastfeeding.\n* Unwilling to comply with study randomization procedures.\n* Unwilling to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.\n* Current participation in another interventional clinical trial.\n* Previous randomization in this study.","25 Years","64 Years",{"count":53,"type":21},216,"INTERVENTIONAL",[56],"NA","The goal of this randomized crossover trial is to compare the differences in psychological and physiological effects of walking in two different outdoor environments (urban\u002Fsuburban commercial environments vs. urban\u002Fsuburban nature areas\u002Fpreserves) in adults with prediabetes. The main questions it aims to answer are:\n\n* Do psychological measures of stress, anxiety, and affect improve more in one type of outdoor environment over the other?\n* Do physiological measures of stress improve more in one type of outdoor environment over the other?\n\nAs this is a crossover trial, participants will serve as their own controls. Researchers will compare both the psychological and physiological effects walking in the two types of outdoor environments.\n\nParticipants will:\n\n* Walk 150-minutes per week for six weeks in each of the two outdoor conditions.\n* Visit the clinic four times, including before and after each six-week walking period.\n* Collect saliva samples immediately proceeding or following the four clinic visits.\n* Return to their pre-study level of physical activity for a 5-week washout period between each of the two walking interventions.",[59,26,60,61],"PreDiabetes","Stress and Anxiety","Stress Biomarkers",[63,64,65,66,67,68],"walking intervention","built environment","outdoor environment","prediabetes","stress","urban",{"date":34,"type":35},{"date":71,"type":35},"2024-06-06",{"date":73,"type":21},"2028-11-30",{"name":75,"class":42},"University of Minnesota",3,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":54,"phases":85,"briefSummary":86,"conditions":87,"keywords":95,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},"100627856","efficacy-of-transcutaneous-auricular-vagus-nerve-stimulation-on-alleviating-major-depressive-disorder-in-patients-with-acute-coronary-syndrome-after-percutaneous-coronary-interventiona-prospective-double-blindrandomized-controlled-study-100627856","NCT07454070","Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation on Alleviating Major Depressive Disorder in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention:A Prospective, Double-Blind,Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Meeting the diagnostic criteria for ACS\n* 14 days to 12 months after successful PCI, with stable vital signs\n* Meeting the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)\n* HAMD-17 score ≥7 and \\\u003C24 (mild-to-moderate depression), with HAMA score \\\u003CHAMD score;\n* Refusal of psychiatric consultation, antidepressant medication, or psychological therapy by the patient or their legal representative after full informed consent\n* Voluntary participation in the study and signing of the informed consent form\n\nExclusion Criteria:\n\n* Severe heart failure (New York Heart Association \\[NYHA\\] class ≥III)\n* Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg)\n* Electrocardiographic abnormalities (first-degree atrioventricular block with PR interval ≥0.20 s, second-degree type II or third-degree atrioventricular block at any time, 24-hour average heart rate ≤50 beats per minute, RR interval ≥3 s) or a history of syncope unrelated to the current ACS\n* Dialysis-dependent patients\n* Previous renal sympathetic denervation or vagal ganglion ablation\n* Expected survival time \\\u003C4 months\n* Pre-PCI diagnosis of severe mental illnesses, including schizophrenia, severe intellectual disability, or substance abuse\n* Current use of antipsychotic medications\n* High suicide risk\n* Pregnant or lactating women\n* Left ear diseases, acute exacerbation of asthma or chronic obstructive pulmonary disease, or other conditions precluding taVNS treatment\n* Implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implantable stimulators (e.g., vagus nerve stimulator, deep brain stimulator)",{"count":84,"type":21},120,[56],"This is a randomized, controlled study. ACS follow- up patients aged 18 to 80 years old with hemodynamic stability, who are 14 days to 1 year after PCI, are screened through the HAMD score and the HAMA score. Patients with a HAMD score greater than 7 points and a HAMD score higher than that of the HAMA, are included in this study.\n\nPatients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 20 minutes each time, twice a day with an 8-week treatment and a 8-week follow-up.\n\nAll treatments were self-administered by the patients at home after they received training from the hospitals.\n\nThe primary observation endpoints include the depression scores of the HAMD. The secondary observation endpoints include the HAMA 、GAD、 response and remission rates of HAMD ，as well as the PCL-C for post-traumatic stress disorder. We also observed the cardiac function indexes measured by echocardiography and the B-type natriuretic peptide .",[88,89,90,91,92,26,93,94],"Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate)","Acute Coronary Syndrome (ACS)","Percutaneous Coronary Intervention (PCI)","Depressive Disorder","Postoperative Psychological Distress","Inflammatory Factors","Randomized Controlled Trial (RCT)",[96,89,97],"Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","Post-Percutaneous Coronary Intervention (PCI) Psychological Distress","2026-06-14",{"date":32,"type":35},{"date":101,"type":35},"2026-01-06",{"date":103,"type":21},"2026-08-10",{"name":105,"class":42},"Jing Han",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":54,"phases":115,"briefSummary":116,"conditions":117,"keywords":125,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":43},"100640010","mobile-dual-task-brain-and-balance-intervention-for-concussion-recovery-100640010","NCT07599475","Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery","Boosting Brain and Balance: A Mobile Dual-Task Intervention for Athletes With Concussion and Mild Traumatic Brain Injury (mTBI)","Inclusion Criteria:\n\n* Adults aged 18 to 40 years\n* Self-reported history of sports-related concussion (SRC) or mild traumatic brain injury (mTBI) within the past 3 to 12 months\n* Meets criteria for mTBI based on a standardized screening method (e.g., Ohio State University TBI Identification Method)\n* Able to safely participate in light physical activity (e.g., walking) and simple cognitive tasks based on self-report and observational screening by the research team\n* Able to read and understand English (if applicable for study materials)\n* Able to provide informed consent\n* Has access to and is able to use a smartphone or mobile device to complete daily app-based activities\n\nExclusion Criteria:\n\n* Age younger than 18 years or older than 40 years\n* History of moderate or severe traumatic brain injury\n* Concussion or mTBI occurring less than 3 months or more than 12 months prior to enrollment\n* Self-reported active medical disease or history of neurological or psychiatric conditions unrelated to concussion\n* Self-reported other medical conditions that would limit safe participation in light physical activity (e.g., walking or balance tasks)\n* Currently on prescribed medications that may significantly affect cognitive function, balance, neurological function, or safe participation in light physical activity\n* Inability to use a smartphone or mobile device required for study participation\n* Inability to read or understand English (as study materials and the mobile application are currently available only in English)","40 Years",{"count":20,"type":21},[56],"This research study examines recovery after a sports-related concussion or mild head injury. Many athletes experience lingering problems with thinking, balance, and mood months after a concussion.\n\nWe are testing a new home-based program called BraW-Day™ (Brain \\& Walk Exercise Every Day). This 14-day program uses a mobile app on your smartphone and combines simple brain exercises (like counting backwards) with walking exercises. The idea is that doing these tasks together may help your brain and body recover more effectively.\n\nWhat You'll Do:\n\n* Two in-person visits at UNLV (baseline and after 14 days) for assessments\n* Daily 15-minute exercises at home using the BraW-Day app\n* Provide a small saliva sample for biomarker testing\n* Complete brief questionnaires about your symptoms and health\n\nPotential Benefits:\n\nYou may experience improvements in thinking, balance, or mood. Even if you don't benefit directly, your participation will help researchers understand how to better support athletes recovering from concussion.\n\nWho Can Join:\n\n* Ages 18-40\n* Had a sports-related concussion or mild head injury within the past 3-12 months\n* Have a smartphone and can safely do light walking and simple tasks\n\nThis study is registered at ClinicalTrials.gov and approved by the UNLV Institutional Review Board to protect your safety and rights.",[118,119,26,120,121,122,123,124],"Mild Traumatic Brain Injury (mTBI)","Sports-related Concussion","Walking","Oculomotor","Saliva","Exosomal microRNA","Cognitive Function",[126,127,128,129],"dual-task","mild traumatic brain injury (mTBI)","sports-related concussion","BraW-Day","NOT_YET_RECRUITING","2026-05-14",{"date":133,"type":35},"2026-05-20",{"date":135,"type":21},"2026-05-15",{"date":137,"type":21},"2027-04-30",{"name":139,"class":42},"Hyunhwa Lee",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":54,"phases":149,"briefSummary":150,"conditions":151,"keywords":158,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":43},"100628633","evolution-of-hypoxic-burden-and-sympatheticparasympathetic-balance-in-patients-with-pulmonary-hypertension-100628633","NCT07464184","Evolution of Hypoxic Burden and Sympathetic\u002FParasympathetic Balance in Patients With Pulmonary Hypertension","HRV&PH","Inclusion Criteria:\n\n* Patients over 18 years of age\n* With precapillary pulmonary hypertension confirmed by pulmonary artery catheterization\n* With an indication for pulmonary artery vasodilator treatment\n* Affiliation with a social security system\n* Women of childbearing age using effective\u002Fhighly effective contraception (see CTFG) (estrogen-progestogen or intrauterine device or tubal ligation) for 6 months and a negative urine pregnancy test at inclusion, for the duration of the study.\n* Postmenopausal women: confirmed diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)\n* Individuals who have read and understood the information letter and signed the consent form\n\nNon-Inclusion Criteria:\n\n* Treatment with non-invasive ventilation\n* Eisenmenger syndrome\n* Systemic scleroderma\n* Neurodegenerative disease other than isolated peripheral neuropathies.\n* Untreated and\u002For uncontrolled cardiac rhythm or conduction disorders, including permanent AF\n* Untreated coronary artery disease or diagnosis of myocardial infarction within the last six months\n* Pacemaker wearer\n* Pregnant or breastfeeding women, or women who are not using reliable contraception\n* Persons deprived of their liberty by administrative or judicial decision or persons under judicial protection\u002Fguardianship or curatorship\n* History of psychological or sensory illness or abnormality that may prevent the subject from fully understanding the conditions required for participation in the protocol or prevent them from giving their informed consent",{"count":148,"type":21},60,[56],"Background and Rationale:\n\nSleep-disordered breathing and nocturnal hypoxemia are highly prevalent in patients with precapillary pulmonary hypertension (PH), and current guidelines recommend systematic sleep assessment in this population. In obstructive sleep apnea, nocturnal hypoxic burden-defined as the area under the SpO₂ desaturation curve associated with respiratory events (%.min\u002Fh)-has demonstrated strong prognostic value for cardiovascular morbidity and mortality. However, its role in precapillary PH has not yet been investigated. Evaluating hypoxic burden in this population may refine indications and therapeutic targets for nocturnal oxygen therapy.\n\nIn addition, pulmonary hypertension is characterized by autonomic nervous system (ANS) dysfunction, including increased sympathetic tone, reduced heart rate variability (HRV), and a higher incidence of cardiac arrhythmias, all associated with worse prognosis. The reduction in HRV is particularly deleterious when occurring during restorative slow-wave sleep (N3), a phase marked by predominant parasympathetic activity essential for cardiovascular recovery and homeostasis. A better understanding of the interaction between nocturnal hypoxemia and ANS modulation may provide new prognostic markers and potential therapeutic targets in PH.\n\nObjectives:\n\n1. To describe the evolution of nocturnal hypoxic burden over time in patients with precapillary pulmonary hypertension (at baseline, 12 months, and 24 months).\n2. To describe the longitudinal evolution of HRV parameters (RMSSD, LF\u002FHF ratio, HF) at baseline, 12 months, and 24 months.\n3. To evaluate cross-sectional correlations (at baseline, M12, and M24) between HRV parameters, hypoxic burden, oxygen desaturation, apnea-hypopnea index (AHI), and clinical status.\n4. To evaluate longitudinal correlations between changes in HRV parameters, hypoxic burden, desaturation, AHI, and clinical status between baseline and M12, and between baseline and M24.\n5. To assess the 2-year prognostic value of HRV parameters and hypoxic burden for adverse clinical outcomes.\n\nStudy Design and Population:\n\nThis is a prospective, single-center observational cohort study conducted at the Pulmonary Hypertension Referral Center of Rouen University Hospital. The cohort design allows longitudinal assessment of HRV, hypoxic burden, and clinical status, enabling both cross-sectional and longitudinal correlation analyses, as well as prognostic evaluation. A total of 60 adult patients (≥18 years) with precapillary pulmonary hypertension confirmed by right heart catheterization and requiring pulmonary arterial vasodilator therapy will be included.\n\nParticipants will undergo full overnight polysomnography (PSG) at:\n\n* Baseline (inclusion)\n* 12 months (M12)\n* 24 months (M24) For incident cases, baseline PSG will be performed prior to initiation of vasodilator therapy. All patients will continue to receive standard-of-care management according to current European guidelines for pulmonary hypertension.\n\nDescriptive analyses and cross-sectional correlations will pool repeated measures (excluding incident baseline values for generalization to prevalent cases). Intra-subject correlation will be accounted for using bootstrap methods. Longitudinal analyses will assess changes over time and prognostic associations. The prognostic value of HRV and hypoxic burden will be evaluated over a 2-year follow-up period. This study explores an original dimension of precapillary pulmonary hypertension pathophysiology by investigating the interaction between nocturnal oxygenation, autonomic dysfunction, and clinical evolution. Identification of hypoxic burden and HRV as prognostic markers may contribute to improved risk astratification and therapeutic optimization in this high-risk population.",[152,153,154,155,156,26,157],"Precapillary Pulmonary Hypertension","Pulmonary Arterial Hypertension","Sleep-disordered Breathing","Nocturnal Hypoxemia","Autonomic Nervous System Dysfunction","Cardiovascular Risk",[159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175],"Precapillary pulmonary hypertension","Pulmonary arterial hypertension","Hypoxic burden","Nocturnal hypoxia","Polysomnography","Sleep-disordered breathing","Heart rate variability (HRV)","RMSSD","LF\u002FHF ratio","High frequency","Autonomic nervous system","Sympathetic activation","Parasympathetic tone","Risk stratification","Prognostic markers","Right heart failure","Apnea-Hypopnea Index (AHI)","2026-04-10",{"date":178,"type":35},"2026-04-15",{"date":180,"type":21},"2026-06-01",{"date":182,"type":21},"2030-01-01",{"name":184,"class":42},"University Hospital, Rouen",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":43},"100622862","heart-rate-variability-and-anxiety-as-predictors-of-emergence-agitation-after-septorhinoplasty-100622862","NCT07389135","Heart Rate Variability and Anxiety as Predictors of Emergence Agitation After Septorhinoplasty","The Role of Heart Rate Variability and Anxiety in Predicting Emergence Agitation in Patients Undergoing Septorhinoplasty : A Prospective Observational Study","Inclusion Criteria:\n\n* Age 18 to 65 years\n* ASA physical status I-II\n* Scheduled for elective septorhinoplasty under general anesthesia\n* Able to provide informed consent and complete questionnaires\n\nExclusion Criteria:\n\n* ASA physical status III or higher\n* Pregnancy or breastfeeding\n* Known dysrhythmia\u002Farrhythmia or autonomic dysfunction, or use of medications that may affect autonomic function\u002FHRV\n* Diagnosed anxiety disorder\n* Use of preoperative anxiolytic medication\n* Inability to understand\u002Fcomplete the anxiety scales\u002Fquestionnaires\n* Emergency surgery","65 Years",{"count":194,"type":21},100,"This prospective observational study aims to evaluate whether preoperative heart rate variability (HRV) and anxiety are associated with, and can help predict, emergence agitation in adult patients undergoing elective septorhinoplasty under general anesthesia. Preoperative anxiety will be assessed using a visual analog scale (VAS) and the State-Trait Anxiety Inventory (STAI-1). Resting HRV will be recorded preoperatively using a chest-strap heart rate monitor and HRV metrics (e.g., SDNN, RMSSD, LF\u002FHF) will be derived. Emergence agitation will be assessed in the post-anesthesia care unit (PACU) using the Richmond Agitation-Sedation Scale (RASS) during the early recovery period. Secondary observations will include early postoperative events such as postoperative nausea and vomiting (PONV) and laryngospasm. The study is planned to enroll approximately 100 participants.",[197,26,198],"Emergence Agitation","Septorhinoplasty","2026-03-30",{"date":201,"type":35},"2026-03-31",{"date":203,"type":35},"2026-02-01",{"date":205,"type":21},"2026-08-01",{"name":207,"class":42},"Konya City Hospital",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":216,"sex":217,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":54,"phases":221,"briefSummary":222,"conditions":223,"keywords":238,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":43},"100629969","impact-of-training-load-on-the-gut-microbiome-and-its-relation-to-exercise-performance-muscle-phenotype-and-markers-of-overreaching-in-healthy-men-100629969","NCT07481578","Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men","ICARUS: Impact of Training Load on the Gut Microbiome and Its Relation to Exercise Performance, Muscle Phenotype, and Markers of Overreaching in Healthy Men: Phase A - Human Trial","ICARUS","Inclusion criteria:\n\n* Males between 18 and 45 years old.\n* Recreationally active individuals, with a weekly exercise training volume between one and six hours per week.\n* Good health status confirmed by a sport medical screening, which includes a sport medical questionnaire and resting electrocardiogram.\n* Body Mass Index (BMI) between 18.5 and 27.5 kg\u002Fm².\n* Masters the Dutch language.\n\nExclusion criteria:\n\n* Engagement in strenuous competitive sports one month prior to or during the study intervention.\n* Medication and vaccination: Pro- or antibiotic treatment during the past three months, non-steroidal anti-inflammatory drugs (NSAIDs) or cholestyramine during the past month, drugs interfering with intestinal permeability (e.g., prokinetics, laxatives, lubiprostone, loperamide, anti-spasmodics, linaclotide, proton pump inhibitors) during the past month. Vaccinations within one month prior to or during the study intervention.\n* Blood donations within three months or plasma donation within one month prior to or during the study intervention.\n* Inflammatory bowel disease (Crohn or colitis ulcerosa) or celiac disease.\n* Diagnosed irritable bowel syndrome.\n* Intake of any performance-enhancing medication or nutritional supplements known to modulate the gut microbiome in the two months prior to or during the study.\n* Substance abuse, including alcohol consumption of more than three units\u002Fday (weekly average).\n* Any injury or pathology considered a contraindication for performing physical exercise, as determined by the medical doctor overseeing the preparticipation medical screening.\n* No access to smartphone and\u002For computer with internet access.\n* No willingness to use the Polar Flow app and MijnEetmeter to collect physical activity, heart rate, sleep, and food intake data.\n* Concomitant participation in another interventional trial, without approval from the research team.\n* Any other reasons considered by the research team that the participant will not complete the study.",true,"MALE","45 Years",{"count":220,"type":21},45,[56],"The goal of this study is to learn how different amounts of supervised indoor cycling training change gut health (gut bacteria, the substances gut bacteria make, and the gut barrier integrity), and how these changes relate to changes in fitness, muscle health, and signs of doing too much training (a state called 'overreaching'). The study includes healthy, recreationally active men aged 18 to 45 years.\n\nThe primary questions, for which the study is powered (sufficient participants included), are:\n\n1. Does moderate load training change blood and faecal levels of butyrate (a short-chain fatty acid made by gut bacteria) after eight weeks compared with a control group?\n2. Compared to moderate load training, do higher training loads lead to different responses in blood and faecal levels of butyrate?\n\nResearchers will compare:\n\n* A control group that does not complete structured training;\n* A moderate-load training group that completes eight weeks of supervised cycling (4x\u002Fweek);\n* A high-load training group that completes four weeks of moderate-load training followed by four weeks of higher training load (twice the number of training sessions).\n\nParticipants will:\n\n* Be randomly assigned to one of the three groups;\n* Complete 8 weeks of supervised indoor cycling sessions if assigned to a training group;\n* Complete four study assessment periods (baseline, after week four, after week eight, and after a short taper (rest period);\n* Provide blood, stool, skeletal muscle, urine, saliva, and breath samples during the assessment periods;\n* Complete fitness and performance tests and questionnaires during the assessment periods.",[224,225,226,227,228,229,230,231,232,233,234,26,235,236,237],"Exercise","Overreaching","Butyrate","Gut Microbiome","Exercise Performance","Skeletal Muscle","Glucose Tolerance","Hormones","Vascular Health","Muscle Adaptation","Physical Fitness","Anthropometric Measurements","Metabolic Health","Food Intake",[239,240,241,242,243,244,245,246,225,247,248,249,26,250,251,252],"Exercise training","Training load","Overload training","Fecal butyrate","Gut health","Exercise performance","Muscle phenotype","Physical fitness","Glucometabolic health","Vascular health","Muscle adaptation","Anthropometrics","Metabolic health","Food intake","2026-03-16",{"date":255,"type":35},"2026-03-19",{"date":257,"type":35},"2024-10-07",{"date":259,"type":21},"2027-05-31",{"name":261,"class":42},"Stefan De Smet",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":216,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":54,"phases":271,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100629603","anxiety-and-physiological-responses-in-ambulatory-surgery-100629603","NCT07476820","Anxiety and Physiological Responses in Ambulatory Surgery","Subjective Anxiety and Physiological Parameters in First-Time Ambulatory Surgery Patients","Inclusion Criteria:\n\n1. Be at least 18 years old.\n2. Undergo outpatient surgery for the first time.\n3. Be mentally clear and able to communicate in Chinese and complete the questionnaire.\n4. Agree to wear physiological monitoring devices and sign the consent form.\n\nExclusion Criteria:\n\n1. Hearing impairment or the need to use a hearing aid.\n2. Currently using sleeping pills\u002Fsedatives or having a mental illness.\n3. Severe cardiovascular disease or having an implanted pacemaker.\n4. Diseases that affect autonomic nervous system function.",{"count":270,"type":21},90,[56],"This study aims to investigate the effects of music intervention on subjective anxiety and physiological indicators, including heart rate, blood pressure, and heart rate variability, in first-time ambulatory surgery patients, and to compare the differential effects between self-selected and standardized music interventions.",[274,26,275,276],"Anxiety","Heart Rate","Blood Pressure",[278,274,279,280],"Music","Ambulatory Surgery","Physiological Indicators","2026-03-12",{"date":283,"type":35},"2026-03-17",{"date":285,"type":21},"2026-02-23",{"date":287,"type":21},"2026-12-30",{"name":289,"class":42},"Da-Yeh University",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":54,"phases":299,"briefSummary":300,"conditions":301,"keywords":307,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100621908","effects-of-controlled-breathing-on-cardiorespiratory-variables-in-multiple-myeloma-100621908","NCT07376733","Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma","Efficacy of a Controlled Breathing and Therapeutic Exercise Program on Cardiorespiratory Variables in Patients With Multiple Myeloma","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed diagnosis of multiple myeloma, currently undergoing active treatment with daratumumab, and under clinical follow-up by the Hematology Department of HU12O.\n* Explicit medical indication for supervised physical activity issued by the responsible hematologist and documented in the medical record.\n* No scheduled hematopoietic stem cell transplantation within the 60 days following the planned start date of the intervention (verified through medical record review).\n* Functional status of ECOG 0-2 (Eastern Cooperative Oncology Group), assessed by a healthcare professional from the Hematology Department, ensuring the ability to perform at least basic and light instrumental activities of daily living, including independent ambulation.\n* Access to a smartphone with stable internet connection, required for monitoring and recording adherence to the intervention.\n* Ability to provide written informed consent, demonstrating understanding of the study's nature, purpose, and procedures.\n\nExclusion Criteria:\n\n* Medical risk contraindicating exercise or breathing techniques:\n\n  * Clinically significant cardiovascular disease, including:decompensated heart failure, acute myocardial infarction within the past 3 months, clinically uncontrolled arrhythmias, unstable angina, acute-phase deep vein thrombosis or pulmonary embolism, pacemakers or cardiac devices whose monitoring parameters contraindicate supervised exercise according to cardiology.\n  * Severe decompensated respiratory disease, such as acute exacerbation of COPD, severe respiratory insufficiency, or persistently low resting oxygen saturation \\\u003C 90% (not correctable).\n* High musculoskeletal or bone risk:\n\n  * Extensive lytic bone lesions, high risk of pathological fracture, or unstable vertebral fracture, documented by imaging or based on the assessment of the Hematology\u002FTraumatology specialist.\n  * Uncontrolled pain that prevents safe participation in an exercise program.\n* Hematologic or systemic conditions contraindicating exercise:\n\n  * Severe anemia: hemoglobin \\\u003C 9 g\u002FdL in women or \\\u003C 8 g\u002FdL in men (latest laboratory test ≤ 14 days).\n  * Active systemic infection contraindicating exercise, fever ≥ 38 °C, or neutropenia \\\u003C 0.5 × 10⁹\u002FL.\n  * Severe cytopenias that, in the opinion of the hematologist, preclude moderate exercise.\n* Functional or procedural limitations:\n\n  * Inability to remain in the supine position for ≥ 5 minutes, required for part of the breathing intervention.\n  * Confirmed pregnancy or reasonable suspicion of pregnancy.\n  * Severe cognitive impairment, major psychiatric disorders, or neurological diseases that limit understanding of the procedures or safe participation.\n  * Significant difficulty understanding the language (spoken or written) that prevents following essential instructions or completing validated questionnaires.",{"count":298,"type":21},26,[56],"A randomized, parallel, double-blind, controlled, clinical trial. Two groups of participants will be included, both receiving a therapeutic exercise intervention and an educational session on the importance of proper breathing over a 6-week period. One of the groups will additionally perform a home-based controlled breathing exercise protocol. Pre- and post-intervention assessments (6 weeks) will be conducted, along with a follow-up evaluation 4 weeks after completion of the intervention. The goal is to determine the effectiveness of adding a controlled breathing exercise program to a therapeutic exercise intervention on cardiorespiratory variables in individuals with multiple myeloma.",[302,303,304,305,306,26],"Multiple Myeloma (MM)","Breathing Techniques","Breathing Exercises","Exercise Activity","Diaphragmatic Breathing",[308,309,310,311,312,313,314],"multiple myeloma","Breathing","Diaphragmatic breathing","Slow breathing","exercise activity","Breathing exercises","heart rate variability","2026-01-21",{"date":317,"type":35},"2026-01-29",{"date":319,"type":21},"2026-01",{"date":321,"type":21},"2026-09",{"name":323,"class":42},"Universidad Complutense de Madrid",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":216,"sex":17,"minAge":331,"maxAge":18,"enrollmentInfo":332,"targetDuration":4,"studyType":54,"phases":334,"briefSummary":335,"conditions":336,"keywords":342,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":360},"100608585","where-wild-things-grow-nature--and-activity-based-group-interventions-for-neurodivergent-children-and-youth-100608585","NCT07203469","Where Wild Things Grow: Nature- and Activity-based Group Interventions for Neurodivergent Children and Youth","Where Wild Things Grow: Immediate and Long-term Impact of Nature- and Activity-based Group Interventions for Neurodivergent Children and Youth in School, Health Care and Leisure Settings in Agder","Inclusion Criteria:\n\n* In PhD 1, participants are recruited on class-level (all) or individual (identified need).\n* In PhD 2, inclusion criteria are patients that participate in the specific interventions.\n\nExclusion Criteria:\n\n* In PhD 2, exclusion criteria include substance misuse, acute psychosis, current suicidal behavior\u002Fideation, and severe eating disorders.","5 Years",{"count":333,"type":21},240,[56],"The goal of this action research project is to develop and implement nature- and activity-based group interventions across health care, school and leisure settings in Southern Norway. The interventions are tailored to support the mental health, self-efficacy and daily life functioning of children and youth in the Agder region, with a particular focus on youngsters who struggle due to neurodivergence, such as Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD) or Tourette's syndrome.\n\nThe main questions we aim to answer are:\n\n1. To what extent does nature- and activity-based outdoor education contribute to improvements in children's quality of life?\n2. To what extent does nature- and activity-based interventions in a health care setting improve children's self-efficacy, self-esteem and quality of life?\n3. Is there a difference in physiological reactions between nature-based provision of education or therapy and traditional indoor provision of education or therapy?\n\nParticipants will take part in a 12-week school-based or health care intervention.",[337,338,339,340,341,26],"Neurodevelopmental Outcomes","ADHD - Attention Deficit Disorder With Hyperactivity","Autism","Tourette Syndrome","Health-Related Quality-of-Life",[343,344,345,346,339,347,348,349,314],"Nature-based","Action research","child and adolescent mental health","ADHD","Health-related quality of life","outdoor therapy","experiential education","2025-10-01",{"date":352,"type":35},"2025-10-02",{"date":354,"type":35},"2025-09-01",{"date":356,"type":21},"2027-06-15",{"name":358,"class":359},"Sorlandet Hospital HF","OTHER_GOV",2,{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":17,"minAge":369,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":54,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":4},"100596495","effects-os-physiotherapeutic-rehabilitation-on-function-autonomic-and-inflammatory-in-patients-with-long-covid-100596495","NCT07046208","Effects os Physiotherapeutic Rehabilitation on Function Autonomic and Inflammatory in Patients With Long Covid","Effects os Physiotherapeutic Rehabilitation on Cardiovascular Autonomic Modulation and Biomarkers Inflammatory and Cardiac Conditions in Patients With Long Covid","LongCovidRehab","Inclusion Criteria:\n\n* both sexes\n* aged 20 and 59 years\n* clinical evaluation and undergoing clinical follow-up of Post COVID-19.\n* least one persistent COVID-19-related symptom.\n\nExclusion Criteria:\n\n* incomplete data.\n* presence of a pacemaker\n* use of antihypertensive drugs that alter HRV\n* persistent pulmonary alterations\n* persistent desaturation\n* anaemia or presence of reinfection.","20 Years","59 Years",{"count":372,"type":21},58,[56],"Introduction: Long COVID is characterized by persistent symptoms that persist for weeks or months after the acute phase of infection, with a significant impact on the cardiovascular and autonomic systems. Objectives: This study aims to evaluate the effects of a physiotherapeutic rehabilitation protocol on cardiovascular autonomic modulation and on inflammatory and cardiac biomarkers in patients with Long COVID. Methodology: This is a controlled clinical trial, carried out in a cardiorespiratory rehabilitation outpatient clinic, involving individuals with a clinical diagnosis of Long COVID undergoing a protocol of 20 aerobic, anaerobic and respiratory rehabilitation sessions. Heart rate variability (HRV) variables will be analyzed using linear and non-linear methods, in addition to serum levels of CKMB, LDH, ferritin and C-reactive protein. Expected results: Rehabilitation is expected to provide an improvement in autonomic function and a reduction in inflammatory and cardiac markers, contributing to the understanding of the pathophysiological mechanisms of Long COVID and helping to propose evidence-based therapeutic strategies.",[376,26,377,378],"Long COVID","Cardiac Biomarkers","Inflammatory Biomarkers","2025-06-29",{"date":381,"type":35},"2025-07-01",{"date":383,"type":21},"2025-08-11",{"date":385,"type":21},"2026-09-30",{"name":387,"class":42},"Universidade do Estado do Pará"]