[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-disordered-breathing-sdb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-disordered-breathing-sdb":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,53,87,112,157,189,213,235,258,285,312,337,367,386,428],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100627110","start-cpap-therapy-in-obstructive-sleep-apnea-patients-after-atrial-fibrillation-ablation-100627110",false,"NCT07444372","Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation","Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation: A Multicenter, Open-label, Randomized Clinical Trial","STOP-AFib","Inclusion Criteria:\n\nPatients must meet all of the following conditions to be eligible for the study:\n\n* Age 18-75 years.\n* Patients with persistent AF scheduled for first-time catheter ablation.\n* Diagnosed with OSA.\n* Able to tolerate CPAP therapy.\n* Capable of understanding and complying with the study protocol.\n* Willing to sign the informed consent form.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from the study:\n\n* Secondary AF.\n* Left atrial anteroposterior diameter 60mm (measured via parasternal long-axis view).\n* Left ventricular ejection fraction \\\u003C 30%.\n* Comorbid moderate-to-severe mitral stenosis or history of prosthetic valve replacement (mechanical or bioprosthetic).\n* Pregnant or breastfeeding women.\n* History of myocardial infarction, percutaneous coronary intervention, or cardiac surgery within 3 months prior to screening.\n* History of stroke or transient ischemic attack within 6 months prior to screening.\n* Perioperative complications related to the ablation procedure occurring prior to randomization.\n* Inability to discontinue antiarrhythmic drugs (AADs) post-procedure due to other reasons.\n* Life expectancy \\\u003C 1 year.\n* Central sleep apnea.\n* Conditions requiring ventilatory support, including obesity hypoventilation syndrome (defined as BMI \\> 30kg\u002Fm² and awake PaCO₂ \\> 45mmHg), amyotrophic lateral sclerosis, or chronic obstructive pulmonary disease with \\> 1 episode of respiratory failure or hypercapnia.\n* Treatment-emergent central sleep apnea during CPAP tolerance assessment that cannot be corrected prior to randomization.\n* Receipt of instrumental or surgical treatment for OSA within 3 months prior to screening, including CPAP, oral appliances, ENT surgery, or bariatric surgery.\n* Use of glucagon-like peptide-1 receptor agonists, glucose-dependent insulinotropic peptide receptor agonists, or glucagon receptor agonists for weight loss within 3 months prior to screening, or plans to initiate such medications within the next year.\n* Current participation in other drug or device trials.","ALL","18 Years","75 Years",{"count":21,"type":22},658,"ESTIMATED","INTERVENTIONAL",[25],"NA","Atrial fibrillation (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Previous studies have established a strong association between obstructive sleep apnea (OSA) and the risk of AF recurrence following ablation. While continuous positive airway pressure (CPAP) is the standard intervention for OSA, and some observational studies suggest it may reduce post-ablation recurrence in patients with comorbid OSA, small randomized controlled trials have failed to confirm a clear benefit, potentially due to poor adherence.\n\nThis study aims to evaluate the clinical benefit of post-ablation CPAP therapy in AF patients with comorbid OSA.\n\nParticipants will:\n\n* Be randomly assigned to either the CPAP group or the usual care group.\n* If in the CPAP group, use a CPAP device for 12 months.\n* Wear an ambulatory ECG recorder for a 7-day period at 3, 6, 9, and 12 months post-operation.\n* Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after their procedure.",[28,29,30,31,32,33],"Obstructive Sleep Apnea","Sleep Disorder (Disorder)","Atrial Fibrillation (AF)","Sleep Disordered Breathing (SDB)","Arrhythmia","Continuous Positive Airway Pressure",[28,33,35,36,37,38,39],"Atrial Fibrillation","Ablation of atrial fibrillation","Sleep Disordered Breathing","Clinical Trial","Catheter Ablation","RECRUITING","2026-06-14",{"date":43,"type":44},"2026-06-16","ACTUAL",{"date":46,"type":44},"2026-05-12",{"date":48,"type":22},"2029-01-31",{"name":50,"class":51},"Beijing Anzhen Hospital","OTHER",27,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100638521","early-dental-risk-screening-for-pediatric-sleep-disordered-breathing-100638521","NCT07581938","Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing","Inclusion Criteria:\n\n* Ages 8-13 years old\n* American Society of Anesthesiologists Class I or II\n* Ability to read and understand the English or Spanish language\n* Ability to assent, with parent\u002Flegal guardian able to provide informed consent\n* Access to a smartphone capable of supporting the wearable monitoring application\n\nExclusion Criteria:\n\n* Diagnosis of a craniofacial syndrome or condition known to significantly alter craniofacial morphology\n* Prior diagnosis of sleep disordered breathing and\u002For obstructive sleep apnea\n* History of adenotonsillectomy\n* Prior or current orthodontic treatment\n* Prior orthognathic surgery",true,"8 Years","13 Years",{"count":63,"type":22},60,"OBSERVATIONAL","This is a prospective, cross-sectional observational study designed to evaluate the Pediatric Sleep Questionnaire (PSQ) as a screening tool for sleep-disordered breathing (SDB) risk in a pediatric dental setting. Children aged 8-13 years will be classified as low- or high-risk for SDB based on PSQ scores and compared using physiologic sleep parameters obtained from a wearable, FDA-cleared home sleep monitoring device, alongside psychosocial assessments and craniofacial measurements derived from lateral cephalometric radiographs. Findings will inform the feasibility and accuracy of incorporating validated SDB screening into routine pediatric dental care.",[67,31,68],"Early Risk Screening for Sleep Disordered Breathing in a Dental Setting","Obstructive Sleep Apnea (OSA)",[70,71,68,31,72,73,74,75,76],"Pediatric Sleep Questionnaire","Apnea","Pediatric Dentistry","At-Home Sleep Study","Pediatric","Screening","Lateral Ceph","2026-06-02",{"date":79,"type":44},"2026-06-04",{"date":81,"type":22},"2026-06",{"date":83,"type":22},"2027-05",{"name":85,"class":51},"University of North Carolina, Chapel Hill",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":86},"100618527","effect-of-adenotonsillectomy-on-spinal-curve-magnitude-in-children-with-sleep-disordered-breathing-100618527","NCT07332780","Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing","A Randomized Controlled Study of Adenotonsillectomy on Spinal Curve Magnitude in Children With Mild Sleep-Disordered Breathing","Inclusion Criteria:\n\n1. Age between 6 and 15 years.\n2. Diagnosed with mild SDB, defined as: Obstructive Apnea-Hypopnea Index (OAHI) ≤5 events\u002Fhour on a laboratory-based PSG performed within the past 6 months, AND parental report of habitual obstructive breathing symptoms (e.g., snoring, mouth-breathing, witnessed apneas) occurring \\>3 nights per week on average.\n3. Tonsillar hypertrophy grade ≥2 (on a scale of 0-4) and deemed an appropriate candidate for AT upon ENT evaluation (i.e., no absolute contraindications such as submucous cleft palate).\n4. Has undergone radiographic screening for idiopathic scoliosis at the first clinic visit.\n5. Skeletally immature (Risser sign 0-3) with spinal Cobb angle \\\u003C 40 degrees.\n6. Informed consent\u002Fassent provided by the participant and guardian.\n\nExclusion Criteria:\n\n1. Unwillingness or inability to comply with study procedures.\n2. Plans to relocate outside the study area within 24 months.\n3. Previous tonsillectomy or adenoidectomy.\n4. Recurrent tonsillitis meeting guideline criteria for immediate AT.\n5. Severe OSA (OAHI \\>10 or as per clinician judgment) or significant hypoxemia requiring immediate CPAP therapy.\n6. Severe chronic conditions that could confound outcomes, including but not limited to:\n\n   * Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis.\n   * History of spine surgery or significant spinal injury.\n   * Spinal tumor.\n   * Leg length discrepancy \\>20 mm.\n   * Severe cardiopulmonary disease (e.g., cystic fibrosis, congenital heart disease).\n   * Significant cardiac arrhythmia noted on PSG.\n   * Bleeding disorders, Sickle Cell Disease.\n   * Uncontrolled diabetes, narcolepsy, or asthma.\n   * Known genetic, craniofacial, neurological, or psychiatric conditions likely to affect the airway or study participation.\n   * Severe obesity (BMI z-score ≥ 3).","6 Years","15 Years",{"count":97,"type":22},160,[25],"This study aims to determine the effect of adenotonsillectomy (AT) surgery on the progression of spinal curvature in children with mild sleep-disordered breathing (SDB) and concurrent scoliosis, as well as its potential role in preventing the de novo development of scoliosis in children with SDB.",[101,102,68],"Sleep-disordered Breathing (SDB)","Idiopathic Scoliosis","2026-05-14",{"date":105,"type":44},"2026-05-15",{"date":107,"type":44},"2025-07-11",{"date":109,"type":22},"2028-07-31",{"name":111,"class":51},"Second Affiliated Hospital of Wenzhou Medical University",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":86},"100632974","impact-of-transcatheter-aortic-valve-implantation-and-mitral-valve-repair-on-sleep-disordered-breathing-100632974","NCT07520656","Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing","Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing","SLEEP-VALVE","Inclusion Criteria:\n\n* Adult patients undergoing TAVI or M-TEER\n* Ability to undergo polysomnography\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Inability to undergo sleep study (polysomnography)\n* Inability to complete follow-up at 6 months\n* Cognitive impairment (e.g., dementia)\n* Refusal to participate",{"count":121,"type":22},150,"This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients with significant valvular heart disease. Patients undergoing TAVI or M-TEER will be evaluated with full polysomnography prior to the intervention and at 6 months follow-up. Changes in sleep parameters, including apnea-hypopnea index (AHI), central and obstructive apnea indices, oxygen desaturation, and sleep architecture, will be assessed. In addition, the study will explore the association between changes in SDB and echocardiographic as well as arrhythmic parameters. The findings are expected to improve the understanding of the interaction between valvular heart disease and SDB and to identify potential benefits of transcatheter interventions on sleep-related outcomes.",[101,124,125],"Aortic Valve Stenosis","Mitral Valve Regurgitation",[127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147],"tavi","m-teer","sleep apnea","sleep disordered breathing","aortic stenosis","aortic valve","mitral regurgitation","AS","MR","mitral valve","transcatheter","sdb","sleep-disordered breathing","obstructive sleep apnea","osa","central sleep apnea","csa","transcatheter aortic valve implantation","mitral valve repair","MitraClip","valvular heart disease","2026-04-02",{"date":150,"type":44},"2026-04-09",{"date":152,"type":44},"2025-07-20",{"date":154,"type":22},"2029-09-01",{"name":156,"class":51},"Aristides Plaitis",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":86},"100437098","sleep-disordered-breathing-and-neurocognitive-assessment-in-children-and-young-adults-100437098","NCT04971850","Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults","Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults","TRSPed","Inclusion Criteria:\n\n* Patients aged 1 to 20 years with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study\n* Written informed consent\n\nExclusion Criteria:\n\n* No social insurance\n* Significant psychomotor retardation\n* Cooperation not possible\n* Significant agitation\n* Acute condition and\u002For temporary drug treatments that may interfere with the results of PSG (upper or lower airway infection)\n* Patient under guardianship\u002Fcuratorship","1 Year","20 Years",{"count":168,"type":22},1200,[25],"One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and\u002For correlation with clinical signs of SDB.\n\nThe primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.",[101],[173,174,175,176,177,178,179],"Sleep-disordered breathing (SDB)","Poly(somno)graphy (P(S)G)","Cerebral oxygenation","Cyclic alternating pattern (CAP)","Psychological and neuropsychological tests","Screening questionnaires","Treatment of SDB","2026-03-30",{"date":182,"type":44},"2026-04-03",{"date":184,"type":44},"2022-02-02",{"date":186,"type":22},"2028-02",{"name":188,"class":51},"Assistance Publique - Hôpitaux de Paris",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":197,"enrollmentInfo":198,"targetDuration":199,"studyType":64,"phases":4,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100623576","metabolic-characteristics-and-prognostic-model-of-acute-coronary-syndrome-complicated-with-obstructive-sleep-apnea-100623576","NCT07398430","Metabolic Characteristics and Prognostic Model of Acute Coronary Syndrome Complicated With Obstructive Sleep Apnea","Metabolic Characteristics Analysis and Precise Prognostic Model Establishment for Patients With Acute Coronary Syndrome Complicated With Obstructive Sleep Apnea","OSA-ACS-Met","Inclusion Criteria:\n\n* Age 18-85 years.\n* Diagnosed with ACS, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina.\n* Willing to participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* Cardiogenic shock or cardiac arrest.\n* Central sleep apnea or other types of sleep disordered breathing.\n* Previous or current treatment with continuous positive airway pressure.\n* Inability to complete polysomnography or invalid data.\n* Malignancy or life expectancy \\\u003C 1 year.","85 Years",{"count":168,"type":22},"12 Months","Obstructive sleep apnea (OSA) significantly increases the risk of cardiovascular events in patients with acute coronary syndrome (ACS), yet the underlying metabolic mechanisms remain unclear. This study aims to analyze the metabolic characteristics of ACS patients with OSA using metabolomics based on a prospective cohort. The study intends to construct an artificial intelligence-based risk stratification model to improve prognosis prediction and facilitate precision medicine for this population.",[31],"NOT_YET_RECRUITING","2026-02-04",{"date":205,"type":44},"2026-02-09",{"date":207,"type":22},"2026-02-01",{"date":209,"type":22},"2027-12-31",{"name":211,"class":212},"Beijing Hospital","OTHER_GOV",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":86},"100619034","comprehensive-care-of-sleep-disordered-breathing-100619034","NCT07339371","Comprehensive Care of Sleep Disordered Breathing","A Prospective Cohort Study on Comprehensive Care of Sleep Disordered Breathing (Care-SDB Study)","Care-SDB","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients who have completed sleep breathing monitoring within 1 month prior to enrollment.\n* Capable of providing signed informed consent.\n\nExclusion Criteria:\n\n* Estimated life expectancy of less than 3 months.\n* Refusal to participate in the study.\n* Inability to cooperate with baseline data collection or follow-up evaluations.",{"count":222,"type":22},11100,"The Comprehensive Care of Sleep Disordered Breathing study (Care-SDB) is a prospective, multi-center, registry-based cohort study designed to investigate the integrated management of sleep-disordered breathing (SDB). The investigators aim to establish a nationwide SDB cohort and biobank to identify prognostic biomarkers, explore pathogenic mechanisms, and evaluate optimal treatment models. A total of 11,100 adult patients with recent sleep monitoring will be enrolled and followed longitudinally for up to 5 years. Data collection, including clinical outcomes and major adverse events, will be managed via a unified Electronic Data Capture platform. The results from Care-SDB are expected to provide critical evidence-based guidance for the risk stratification, standardized intervention, and personalized management of patients with sleep-disordered breathing.",[31],[226,37],"Comprehensive Care","2026-01-19",{"date":229,"type":44},"2026-01-21",{"date":231,"type":22},"2026-01-01",{"date":233,"type":22},"2029-01-01",{"name":50,"class":51},{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":255,"locationsCount":86},"100611655","neurostimulation-for-sleep-disordered-breathing-sdb-100611655","NCT07243405","Neurostimulation for Sleep Disordered Breathing (SDB)","The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing","ECLIPSE 2","Inclusion Criteria:\n\n* Subject does not tolerate, not compliant to, or have access to alternative Sleep Disordered Breathing treatments\n* Subject has moderate to severe sleep disordered breathing as diagnosed by PSG\n\nExclusion Criteria:\n\n* Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.\n* Any reason for which, in the judgement of the investigator, the subject is considered to be a poor study candidate\n* Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.\n* Subject has a need for chronic supplemental oxygen therapy for any reason\n* Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness\n* Subject has severe chronic kidney disease\n* Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study\n* Subject conducts work or regular activities requiring vigilance\n* Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study\n* Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices\n* Subject has an active systemic infection at the time of implant\n* Subject has clinical evidence of immunodeficiency\n* Any condition likely to require future MRI or diathermy\n* Subject is pregnant\n* Subject has severe nasal obstruction that could restrict airflow\n* Subject has any trauma to the upper airway\n* Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat",{"count":244,"type":22},45,[25],"This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.",[31,248],"Sleep Apnea","2025-11-17",{"date":251,"type":44},"2025-11-21",{"date":253,"type":44},"2025-07-30",{"date":209,"type":22},{"name":256,"class":257},"Lunair Medical","INDUSTRY",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100603419","detection-of-sleep-stages-and-arousals-using-neural-network-classifiers-100603419","NCT07136272","Detection of Sleep Stages and Arousals Using Neural Network Classifiers","Validation of Smart Mask V1 System: A Clinical Study Comparing a System for Detecting Sleep Stages and Arousals to Manual Polysomnography Scoring","SSAM","Inclusion Criteria:\n\n* Subjects must be at least 18 years of age at screening.\n* Subjects are individuals diagnosed with sleep-disordered breathing who have been prescribed PAP therapy or referred for a PSG.\n* Subjects must be willing and able to comply with the study requirements, which include using test, reference and predicate devices (if needed), completing training, interacting with study personnel and filling out questionnaires.\n* Subjects must be fluent in English.\n* Subject must be willing to undergo the screening and informed consent process prior to enrollment in the study.\n* Subjects must be deemed suitable candidates for this study based on the PI's evaluation of their condition and the features of the investigational device being tested.\n\nExclusion Criteria:\n\n* Subjects unable or unwilling to wear a PAP mask as required for the study.\n* Subjects currently employed by, previously employed by or in any way affiliated (consulting, etc.) with any manufacturer or provider of PAP equipment and\u002For services.\n* Subjects who are pregnant.\n* Subjects with or requiring an implantable device, such as an electronic defibrillator, pacemaker, or other device.\n* Subjects considered by the PI to be medically unsuitable for study participation.",{"count":121,"type":22},[25],"The objective of this clinical study is to evaluate the accuracy of the Smart Mask V1 System (herein 'Smart Mask') in measuring sleep stages-Stage N1\u002FN2, Stage N3, Rapid Eye Movement (herein 'REM'), and WAKE-arousals, and the Arousal Index in adults diagnosed with sleep-disordered breathing, such as obstructive sleep apnea (herein 'OSA'). The Smart Mask operates in concert with a Wireless Access Module (herein 'WAM'), which is connected to a standard positive air pressure (herein 'PAP') device used in the treatment of OSA. Collectively the Smart Mask and WAM operate neural network classifier algorithms to determine sleep stages, arousals, and Arousal Index. These algorithms are coded into an embedded software system called the Sleep Staging and Arousal Module (herein 'SSAM') that operates directly on the WAM. The SSAM processes the following parameters, collected while the participant is asleep: 1) instantaneous values of pulse rate, determined from embedded optical sensors within the Smart Mask that measure photoplethysmogram waveforms (herein 'PPG'); and 2) full-resolution flow waveforms measured by sensors within the PAP device and retrieved by the WAM.\n\nDuring the study, volunteer participants (preferably those with OSA) will undergo an overnight sleep study in sleep testing facility located at three separate clinical sites. The test device (comprising the SSAM operating on the WAM) will retrospectively determine sleep stages and arousals, after the participant's sleep session has concluded. To evaluate the accuracy of the test device, its values of sleep stages, arousals, and Arousal Index will be compared to those parameters determined by polysomnography (herein 'PSG', a recognized gold-standard reference) and EnsoSleep (a FDA-cleared predicate device, and specifically a software package that uses artificial intelligence (AI) to determine sleep stages and arousals). Each volunteer participant will wear an FDA-cleared wrist-worn pulse oximeter called the 'Checkme O2' which generates data (specifically PPG waveforms and values of SpO2 and pulse rate) for the EnsoSleep cloud-based software platform.\n\nThe main questions this study aims to answer are:\n\n* Can the Smart Mask accurately identify different sleep stages compared to the EnsoSleep device?\n* Can the Smart Mask accurately identify sleep arousals and calculate the Arousal Index compared to the EnsoSleep device?\n\nAnswers to these questions will be derived through comparative statistical analysis involving the test device, the gold-standard PSG reference, and the FDA-cleared predicate device, employing methodologies similar to those used in the validation of the EnsoSleep. The study will include two cohorts. The first cohort will include approximately 75 participants from a single clinical site and will be used for device training purposes. The second cohort will consist of approximately 72 different participants, and will be used to validate the test device. Participants in the second cohort will be distributed roughly evenly across two separate clinical sites.",[31,248],[271,272,273,274],"Sleep Scoring","Sleep Stages","Arousals","Neural Network Classifier","2025-09-10",{"date":277,"type":44},"2025-09-16",{"date":279,"type":22},"2025-09",{"date":281,"type":22},"2025-12",{"name":283,"class":257},"Pathway Medtech, LLC.",3,{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":86},"100599611","validation-of-the-smart-mask-v1-system-and-its-measurements-of-spo2-and-pulse-rate-100599611","NCT07086742","Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate","SMV1: PPG","Inclusion Criteria:\n\n* Healthy subjects with ASA health score of I or II\n* Subjects aged between ≥ 18 and ≤ 65 years.\n* Subjects who have provided informed consent and are willing to comply with the study procedures.\n\nExclusion Criteria:\n\n* Heavy smokers or individuals exposed to high levels of carbon monoxide resulting in elevated carboxyhemoglobin levels.\n* Individuals with conditions that result in elevated methemoglobin levels.\n* Individuals with hypoxia (SpO2 \\\u003C 95% at 21% O2).\n* Severe claustrophobia.\n* Subjects known with altitude sickness.\n* Subjects who are obese (BMI ≥ 35 kg\u002Fm2).\n* Subjects with a known history of moderate to severe heart, lung, kidney or liver disease.\n* Subjects diagnosed with moderate to severe asthma.\n* Subjects with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, that in the investigator's opinion, would make them unsuitable for study participation.\n* Subjects with any other serious systemic illness.\n* Any injury, deformity, or abnormality at the sensor sites that, in the investigator's opinion, would interfere with the correct functioning of the test or reference devices.\n* Subjects with a history of fainting or vasovagal response.\n* Subjects with a history of sensitivity or allergy to local anesthetics or disinfectants if included in the IN study.\n* Subjects diagnosed with Raynaud's disease.\n* Subjects with unacceptable collateral circulation based on examination by the investigator.\n* Subjects who are pregnant, lactating or trying to become pregnant.\n* Subjects unable or unwilling to provide informed consent or comply with study procedures.\n* Subjects with any other condition that, in the investigator's opinion, would make them unsuitable for the study.\n* Subjects who refuse to remove nail polish from their index finger.\n* Volunteers not willing to remove facial make-up.","65 Years",{"count":294,"type":22},36,[25],"The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18 to 65.\n\nMore specifically, the study is directed at answering the following questions:\n\n* Can the Smart Mask accurately measure SpO2 levels compared to established reference devices (reference oximeters, blood gas) throughout the range of SpO2 \\~ 70 - 100%?\n* Can the Smart Mask accurately measure PR during the same conditions?\n* Does skin pigmentation impact the accuracy of Smart Mask's measurements of SpO2 and PR.\n\nThe following reference devices will be used in the study:\n\n* An FDA-cleared fingertip pulse oximeter (Nellcor Portable SpO2 Patient Monitoring System, PM10N)\n* A laboratory-grade CO-oximeter (Radiometer ABL90 FLEX) that analyzes oxygen saturation from blood samples.\n\nStudy participants will:\n\n* Wear the Smart Mask on their face and a fingertip pulse oximeter while lying down\n* Breathe air with gradually reduced oxygen levels inside a specialized hypoxia room while being closely.\n* In a second phase of the study, have a catheter inserted into a wrist artery for blood sampling to directly measure oxygen levels with the CO-oximeter.",[101,248,298],"Sleep Quality",[300,301,302,303],"Pulse Oximeters","SpO2","Sleep apnea","postive air pressure","2025-08-13",{"date":306,"type":44},"2025-08-17",{"date":308,"type":22},"2025-09-01",{"date":310,"type":22},"2025-12-31",{"name":283,"class":257},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":319,"maxAge":320,"enrollmentInfo":321,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100598879","sleep-disordered-breathing-in-children-with-cerebral-palsy-at-increased-risk-of-respiratory-disorders-100598879","NCT07077226","Sleep-Disordered Breathing in Children With Cerebral Palsy at Increased Risk of Respiratory Disorders","Prevalence and Clinical Impact of Sleep-Disordered Breathing in Children With Cerebral Palsy at Increased Risk of Respiratory Disorders","Inclusion Criteria:\n\n* Aged less than 18 at the time of the sleep study\n* A diagnosis of Cerebral palsy\n* Written informed consent\n* Underwent a sleep study at one of the centers participating in the study during the reporting period (January 2020-December 2023)\n\nExclusion Criteria:\n\n* None","0 Years","17 Years",{"count":121,"type":22},"Currently, there are few and qualitatively unsatisfactory epidemiological data on the prevalence of sleep-disordered breathing (SDB) in children with cerebral palsy (CP).\n\nThe investigators aim to conduct a multicentre retrospective study to assess the presence of SDB in children with CP undergoing sleep studies (polysomnography or polygraphy).",[101],[139,325,326],"cerebral palsy","Polysomnography","2025-07-23",{"date":329,"type":44},"2025-07-28",{"date":331,"type":22},"2025-09-15",{"date":333,"type":22},"2027-04-15",{"name":335,"class":51},"GUIDO CAMANNI",9,{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":59,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":345,"conditions":346,"keywords":350,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":86},"100574173","sleep-disordered-breathing-and-multimorbidity-the-xiangya-sdb-cohort-study-100574173","NCT06755840","Sleep Disordered Breathing and Multimorbidity: The Xiangya SDB Cohort Study","Inclusion Criteria:\n\n* 1\\) Participants who were suspected of sleep disordered breathing must complete at least one overnight sleep monitoring at the Sleep Medicine Center at Xiangya Hospital.\n* 2\\) Participants can finish any assessment for each comorbid system by questionnaires, scales, physical examinations and tests, etc. independently or with the assistance.\n* 3\\) Participants agreed to participate in this study with signing an informed consent form.\n\nExclusion Criteria:\n\n* Participants who refused to participate in this study or whose clinical data was lost.",{"count":344,"type":22},15000,"Sleep disordered breathing (SDB) is one of the most common sleep disorders, including obstructive sleep apnea (OSA), central sleep apnea (CSA), sleep-related hypoventilation, hypoxemia, etc., with OSA being the most prevalent. Also, SDB shows high comorbidities with multisystem diseases. Furthermore, compared to patients with pure SDB, those comorbid with SDB and other disorders like cardiometabolic dysfunction and cognitive impairment experience poorer quality of life, higher rate of disease progression and mortality, and a greater economic burden. Currently, there are limited cohorts to study the associations between SDB and multisystem diseases. The aim of this study is to establish an ambispective clinical cohort for SDB in Xiangya hospital from central-south China (Xiangya Sleep Disordered Breathing Cohort, Xiangya SDB cohort) including retrospective part and prospective part, which covers multi-dimensional data of sleep monitoring, demographic, daily behaviors, clinical manifestations and comorbidities status, life quality, treatment information and evaluation, etc. by self-reported questionnaires and objective assessments and tests. Besides, whole peripheral blood is drawn for following biomarkers study and omics analysis. The main goal is to achieve precise management of SDB and related multimorbidity, containing to early identify risk individuals for multisystem impairment, significantly improve their prognosis and ultimately enhance overall health. In detail: first, to reveal how multisystem impairment related to SDB evolves; second, to identify which indicators closely involve system dysfunction due to SDB; third, to build an efficient model and a cost-effective platform to screen high-risk population and tract therapeutic effect.",[31,248,347,348,349],"Cardiometabolic Diseases","Multimorbidity","Neurodegenerative Diseases",[130,140,142,351,352,353,354,355,356,357],"cardiovascular diseases","metabolic diseases","respiratory diseases","nervous system diseases","mental disorders","neoplasms","multimorbidity","2025-04-01",{"date":360,"type":44},"2025-04-03",{"date":362,"type":44},"2025-01-15",{"date":364,"type":22},"2035-10-31",{"name":366,"class":51},"Xiangya Hospital of Central South University",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":240,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":86},"100583998","neurostimulation-for-sleep-disordered-breathing-100583998","NCT06883617","Neurostimulation for Sleep Disordered Breathing","ECLIPSE 1","Inclusion Criteria:\n\n* Subject does not tolerate, not compliant to or have access to alternative Sleep Disordered Breathing treatments\n* Subject has moderate to severe sleep disordered breathing as diagnosed by PSG\n\nExclusion Criteria:\n\n* Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.\n* Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate\n* Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.\n* Subject has a need for chronic supplemental oxygen therapy for any reason\n* Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness\n* Subject has severe chronic kidney disease\n* Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study.\n* Subject conducts work or regular activities requiring vigilance\n* Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.\n* Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices\n* Subject has an active systemic infection at time of implant.\n* Subject has clinical evidence of immunodeficiency.\n* Any condition likely to require future MRI or diathermy\n* Subject is pregnant\n* Subject has a severe nasal obstruction that could restrict airflow\n* Subject has any trauma to the upper airway\n* Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.",{"count":244,"type":22},[25],"This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.",[31,248],"2025-03-19",{"date":380,"type":44},"2025-03-20",{"date":382,"type":44},"2025-01-13",{"date":384,"type":22},"2027-12-15",{"name":256,"class":257},{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":17,"minAge":393,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":401,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":86},"100579000","comparing-cpap-and-bipap-for-sleep-disordered-breathing-in-people-with-cervical-spinal-cord-injuries-100579000","NCT06818604","Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries","Comparison Between CPAP and BiPAP for Management of Sleep Disordered Breathing in Cervical Spinal Cord Injury Patients: a Pilot Randomized Controlled Study","Inclusion Criteria:\n\n* Age \\>= 19 years\n* Cervical spinal cord injury (ASIA A, B, or C). This will include patients with upper (C1-C4) and lower (C5-C7) spinal cord injuries\n* Presence of sleep disordered breathing, defined as AHI \\> =15 events\u002Fhour by home sleep apnea test (HSAT)\n\nExclusion Criteria:\n\n* On CPAP or BiPAP prior to spinal cord injury\n* Hypoventilation syndrome (elevated venous carbon dioxide, PvCO2\\>50 mm Hg)","19 Years",{"count":395,"type":22},32,[25],"Sleep-disordered breathing (SDB) is common in individuals with cervical spinal cord injuries, with studies suggesting prevalence rates ranging from 27% to 62%. The condition often leads to daytime sleepiness, fatigue, and poor participation in rehabilitation. Positive airway pressure therapy can be used to treat the condition; however, some individuals find continuous positive airway pressure (CPAP), which applies the same pressure during inhalation and exhalation, difficult to use. Bilevel positive airway pressure (BiPAP) offers different pressures for inhalation and exhalation, which may be more comfortable and potentially improve adherence in this patient population. However, limited evidence compares CPAP and BiPAP in individuals with cervical spinal cord injuries.\n\nThis pilot study will enroll 32 adult participants with cervical spinal cord injuries who have moderate to severe SDB (defined as an AHI of 15 events\u002Fhour or greater). Participants will be randomly assigned to either CPAP or BiPAP therapy for 4 weeks. Device usage per night will be measured, and data on daytime sleepiness, fatigue, and sleep quality will be collected at baseline, 2 weeks, and 4 weeks. The investigators aim to determine whether BiPAP improves adherence and symptoms compared to CPAP in this patient population.",[399,31,248,400],"Spinal Cord Injuries (SCI)","Cervical Spinal Cord Injruy",[130,402,28,403,404,33,298,405,326,406,407,408,409,410,411,412,413,414,415,416,417,418],"Cervical Vertebrae","Spinal Cord Injuries","Positive Pressure Respiration","Quadriplegia","Tetraplegia","Sleep Wake Disorders","Diaphragmatic Paralysis","Autonomic Dysreflexia","Muscle Weakness","Nocturnal Hypoventilation","Phrenic Nerve","Pulmonary Atelectasis","Spinal Cord Compression","Ventilator Weaning","Neurological Rehabilitation","Sleep Disorders","Activities of Daily Living","2025-02-06",{"date":421,"type":44},"2025-02-10",{"date":423,"type":22},"2025-08-01",{"date":425,"type":22},"2027-09-01",{"name":427,"class":51},"University of British Columbia",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":86},"100578488","sleep-disordered-breathing-in-the-acute-phase-after-stroke-and-neuropsychiatric-outcomes-100578488","NCT06811948","Sleep-Disordered Breathing in the Acute Phase After Stroke and Neuropsychiatric Outcomes","Inclusion Criteria:\n\n* Age \\>18 years\n* Stroke according to WHO definition (31) (ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage)\n* TIA with MRI-verified lesions corresponding to symptoms\n* Informed consent to participate\n\nExclusion Criteria:\n\n* Traumatic stroke\n* Tumor-associated bleeding\n* Expected survival \\\u003C3 months\n* Unconsciousness (RLS \\>3)",{"count":435,"type":22},340,"In people who have had a stroke or a transient ischemic attack (TIA), it is common to have problems with breathing patterns during sleep, particularly a condition called obstructive sleep apnea. Another common long-term problem after a stroke is post-stroke fatigue, which affects function and quality of life after stroke. There is currently no clearly effective treatment for post-stroke fatigue. We are investigating whether there might be a connection between sleep-related breathing disturbances, and the risk of developing long-term post-stroke fatigue\n\nThe project is being conducted at Blekingesjukhuset Karlskrona, and inpatients with stroke are asked to participate. Participants are equipped with a sleep analysis pad under the mattress that measures breathing patterns during the night, as well as a wrist-worn device that measures oxygen saturation in the blood. Participants are also asked about their functional level in daily life and any symptoms of obstructive sleep apnea. One year after the stroke, participants are invited for a follow-up visit where we ask about post-stroke fatigue, depressive symptoms, and treatment and investigations related to the stroke.\n\nWe will then investigate the relationship between sleep-related breathing disturbances, measured early after stroke, and the risk of significant fatigue after the stroke. This could lead to future studies with treatment trials for obstructive sleep apnea in certain individuals with post-stroke fatigue. The study could also lead to potentially increased awareness that these conditions might be connected, which could result in a higher likelihood of detecting treatable obstructive sleep apnea in certain subgroups after stroke.",[438,439,28,31],"Stroke","Fatigue Symptom","2025-01-31",{"date":419,"type":44},{"date":443,"type":22},"2025-02-20",{"date":445,"type":22},"2027-12-20",{"name":447,"class":51},"Blekinge County Council Hospital"]