[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-apnea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-apnea":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,47,67,99,127,155,182,208,237,267,289,315,353,377,401,423,452,480,506,527,548,574,593,614,637],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":29,"conditions":30,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100484569","phase-1-sleep-disordered-breathing-with-opioid-use-100484569",false,"NCT05589753","Sleep Disordered Breathing With Opioid Use","Targeting Chemoreceptor Control of Breathing During Sleep to Mitigate Opioid-Associated Sleep Disordered Breathing","SDB","Inclusion Criteria:\n\n* Veterans, age 18-89 years\n* Veterans with prescription opioids\n\nExclusion Criteria:\n\n* Patients with BMI\\>40kg\u002Fm2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control\n* Patients with history of unresolved\u002Funtreated cardiac disease, including recent myocardial infarction, recent bypass surgery, untreated atrial and ventricular tachy-bradycardias\n* Congestive heart failure with Cheyne-Stokes respiration (CSR)\n* Current unstable angina\n* Recent stroke\n* Untreated schizophrenia\n* Untreated hypothyroidism\n* Unresolved seizure disorder\n* Severe respiratory, neurological, liver and renal diseases\n* Unstable psychiatric disorders\u002Funtreated PTSD\n* Traumatic brain injury\n* Pregnant women\n* Significant sleep disorder such as narcolepsy, parasomnias disorder\n* Failure to give informed consent\n* Patients on tramadol and suboxone\u002Fbuprenorphine",true,"ALL","18 Years","89 Years",{"count":23,"type":24},150,"ESTIMATED","INTERVENTIONAL",[27,28],"PHASE1","PHASE2","There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to identity whether oxygen and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in chronic opioid use via different mechanisms. We will study additional clinical parameters like quality of life, sleep and pain in patients with and without opioid use. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea with opioid use. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea.",[31,32,33],"Sleep Apnea","Opioid Use","Sleep Disordered Breathing","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2019-05-02",{"date":42,"type":24},"2027-03-31",{"name":44,"class":45},"VA Office of Research and Development","FED",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":53,"targetDuration":4,"studyType":25,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":46},"100279862","phase-4-treatment-of-sleep-apnea-in-patients-with-cervical-spinal-cord-injury-100279862","NCT02922894","Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury","Inclusion Criteria:\n\n1. healthy adults between the ages of 18 - 89\n2. chronic spinal cord injury patients (T6 and above), \\> 3 months since injury and not on mechanical ventilation, and have not received mechanical ventilation via tracheostomy in the past.\n\nExclusion Criteria:\n\n1. subjects ≤ 17 yrs old\n2. Pregnant and lactating females\n3. History of head trauma that resulted in neurological symptoms or loss of consciousness\n4. advanced heart, lung, metabolic, liver or chronic kidney disease.\n5. severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy\n6. extreme obesity defined for this protocol as BMI ≥ 40 kg\u002Fm2 (to avoid the effect of morbid obesity on ventilation).",{"count":54,"type":24},100,[56],"PHASE4","This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (\\>6 months post-injury).",[31,59],"Spinal Cord Injury",{"date":37,"type":38},{"date":62,"type":38},"2017-06-09",{"date":64,"type":24},"2027-01-30",{"name":66,"class":45},"John D. Dingell VA Medical Center",{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":25,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":46},"100563611","evaluating-the-impact-of-home-based-sleep-apnea-diagnostic-on-well-being-health-behavior-and-af-load-in-patients-with-atrial-fibrillation-using-a-decentralized-platform-100563611","NCT06618417","Evaluating the Impact of Home-Based Sleep Apnea Diagnostic on Well-Being, Health Behavior, and AF Load in Patients With Atrial Fibrillation Using a Decentralized Platform","National Decentral\u002FVirtual Randomized Trial Testing Remote Sleep Apnea Evaluation in Patients With Atrial Fibrillation","VIR-SAAF","Inclusion Criteria:\n\n* Established paroxysmal or persistent AF diagnosis\n* Owning a compatible smartphone\n* 18 years or older\n\nExclusion Criteria:\n\n* Previous investigation for sleep-disturbed breathing\n* Advanced heart failure (left ventricular dysfunction and NYHA III\u002FIV)\n* Occupational driver licenses\n* Pregnancy\n* Doxazosin or Terazosin treatment (alpha-adrenergic antagonists)\n* Peripheral arterial disease with daily intermittent claudication",{"count":76,"type":24},936,[78],"NA","The goal of this clinical trial is to find out if testing for sleep apnea (a condition where breathing stops and starts during sleep) at home can improve well-being in people with atrial fibrillation (an irregular heartbeat condition). About 936 participants will be involved. They will either be tested for sleep apnea and treated, if needed, or not tested at all.\n\nResearchers will compare the well-being and heart-related symptoms of participants who are tested for sleep apnea to those who are not. These will be tracked using a mobile app to monitor symptoms, physical activity, and heart rhythm.\n\nMain hypothesis: Participants with atrial fibrillation who are tested and possibly treated for sleep apnea will have improved quality of life scores (measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire) by at least 5 points after 18 weeks.",[81,31],"Atrial Fibrillation (AF)",[83,84,85,86,87,88],"atrial fibrillation","decentralized","sleep apnea home-evaluation","randomized","digital health","quality of life","2026-06-09",{"date":91,"type":38},"2026-06-10",{"date":93,"type":38},"2024-12-05",{"date":95,"type":24},"2027-06-30",{"name":97,"class":98},"Herlev and Gentofte Hospital","OTHER",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":19,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":25,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100608893","behavioral-optimization-to-overcome-obstructive-sleep-apnea-treatment-barriers-100608893","NCT07207473","Behavioral Optimization to Overcome Obstructive Sleep Apnea Treatment Barriers","Helping Veterans With Obstructive Sleep Apnea Determine What Matters Most in Choosing a Treatment Option: a Randomized Trial","BOOST","Inclusion Criteria:\n\n* referred for an overnight diagnostic sleep test to evaluate for sleep-disordered breathing during the study period\n* currently untreated for OSA (not prescribed therapy in the past year)\n\nExclusion Criteria:\n\n* referral for overnight sleep test is for another reason than to diagnosis sleep-disordered breathing\n* unable to read printed material (e.g., magazine) in English language\n* unable to write\n* unstable medical\u002Fpsychiatric illness (e.g., recent hospitalization)\n* Telephone Mini-Mental State Examination (MMSE) \\\u003C 21 or diagnosis of dementia\n* unstable housing\n* unable to attend study video or in-person visits","50 Years",{"count":109,"type":24},128,[78],"Previous studies have shown that programs encouraging the use of OSA treatments can help patients use these treatments more often, but the improvement is usually modest. This trial will test if giving patients a decision-making tool when they are first diagnosed with OSA, and combining their responses from this tool into a supportive program, will improve sleep quality and help them use their treatment more regularly.",[31],[114,115,116],"sleep apnea","decision making, shared","health priorities","NOT_YET_RECRUITING","2026-06-04",{"date":120,"type":38},"2026-06-05",{"date":122,"type":24},"2026-11-02",{"date":124,"type":24},"2031-03-31",{"name":44,"class":45},2,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":25,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":46},"100618501","phase-3-continuous-positive-airway-pressure-arousability-and-links-to-mechanisms-in-obstructive-sleep-apnea-100618501","NCT07332442","Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea","CALM-OSA","Inclusion Criteria:\n\n* Able to provide informed consent.\n* Clinically confirmed new diagnosis of OSA:\n\n  1. Polysomnography AHI ≥ 10 per hour of sleep and\u002For\n  2. Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording\n\nExclusion Criteria:\n\n* Known non-OSA related conditions associated with sleep-disordered breathing (e.g., a central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder)\n* Use of sleep-inducing medications (e.g., other non-benzodiazepine sedative hypnotic-drugs \\[e.g., zoldpidem\\], benzodiazepines, non-selective antihistamines, trazodone, opiates, barbituates)\n* Known hypersensitivity reaction to eszopiclone\n* Contraindications to its use based on medical history or function (e.g., dizziness at baseline or established mobility problems or imbalance)\n* History of complex sleep behaviors (e.g., NREM or REM parasomnias)\n* Concomitant use of ≥ 2 servings of alcohol per night or other CNS depressant for 2 weeks prior or throughout the study\n* Sleep opportunity of less than 7 hours\n* Severe active depression or other mental health disorders (e.g., schizophrenia, bipolar disorder, personality disorder).\n* History of sleep-walking, sleep-driving, and engaging in other activities while not fully awake\n* History of motor vehicle accidents related to sleepiness and\u002For motor vehicle \"near misses\" (e.g. sleepiness during driving or lane changes)\n* Severe hepatic impairment (liver function tests 2 X the upper limit of normal)\n* Unstable medical condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end-stage renal disease)\n* Females of childbearing potential who are pregnant, breastfeeding, or intend to become pregnant, and women who are in the process of egg donation .",{"count":135,"type":24},250,[137],"PHASE3","The study design is a randomized, controlled clinical trial to test the hypothesis that arousal threshold (ArTH) will affect how individuals with obstructive sleep apnea (OSA, Apnea-Hypopnea Index (AHI) of 10\u002Fhour of higher) respond to CPAP therapy regarding adherence and cognitive function (executive function). Investigators hypothesize that raising ArTH with eszopiclone will improve adherence to CPAP and neurocognitive function with CPAP therapy. Investigators also hypothesize that a lower baseline ArTH is associated with worse CPAP adherence, while a higher baseline ArTH is associated with improved neurocognitive outcomes with CPAP therapy.",[31,140],"Obstructive Sleep Apnea",[142,114,143,144,145],"Continuous Positive Airway Pressure (CPAP)","hypnotic","mechanism","arousability","2026-06-01",{"date":148,"type":38},"2026-06-03",{"date":150,"type":38},"2026-05-18",{"date":152,"type":24},"2030-06",{"name":154,"class":98},"Yale University",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":19,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":25,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":126},"100566034","phase-2-nuestro-sueno-cultural-adaptation-of-a-couples-intervention-to-improve-pap-adherence-and-sleep-health-among-latino-couples-with-implications-for-alzheimers-disease-risk-100566034","NCT06649929","Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve PAP Adherence and Sleep Health Among Latino Couples With Implications for Alzheimer's Disease Risk","Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve Positive Airway Pressure Adherence and Sleep Health Among Latino Couples With Implications for Alzheimer's Disease Risk","Patients inclusion criteria:\n\n* Self-reported Latino ethnicity\n* Age \\>35, 3)\n* Diagnosed with obstructive sleep apnea and intend to start PAP\n* Never used positive airway pressure or-restarting CPAP after 3 months\n* Married or cohabiting with a romantic partner for \\>1 year\n* Able to read\u002Fwrite English or Spanish\n* Access to cellular (active data plan) or Wi-Fi, or able to use study devices in order to complete the telehealth intervention.\n\nPartner inclusion criteria:\n\n* Able to read\u002Fwrite in English or Spanish\n* Interested in improving their sleep (yes\u002Fno)\n* Access to cellular (active data plan) or Wi-Fi, to complete the telehealth intervention or able to use a study device.\n\nPartners of all ethnicities will be invited to participate. The intervention will be delivered in couples preferred language.\n\nExclusion criteria for both patient and partner\n\n* High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)\n* History of cognitive or neurological or major psychiatric disorders\n* Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe chronic obstructive pulmonary disease\n* Patients with need for more complex care (e.g., adaptive servo-ventilation, supplemental oxygen) or concurrent sleep apnea treatment such as bariatric surgery or oral appliance\n* Overnight work \\> 1x per month; 7) Pregnancy\u002Fdesire to become pregnant in the study period; 8) Current participation in behavioral sleep treatment (e.g., cognitive behavioral therapy for insomnia)\n* Concurrent participation in another clinical trial\n* Caregiving for an infant \\\u003C 2 years old or adult who requires overnight assistance","35 Years",{"count":164,"type":24},80,[28],"The goal of this clinical trial is to learn if the culturally adapted couples sleep health intervention (Nuestro Sueno) improves positive airway pressure use and sleep among Hispanic couples in which one partner was diagnosed with sleep apnea and starting positive airway pressure treatment.\n\nThe main questions are:\n\n1. Does Nuestro sueno improve the patient's positive airway pressure use over the first 3 months of using it compared to an information control?\n2. Does Nuestro sueno improve sleep quality for both the patient and partner, compared to an information control?\n3. Does Nuestro sueno improve other aspects of life including quality of life and memory, compared to an information control?",[31,168],"Sleep Disturbance",[170,171,172],"sleep","couples","positive airway pressure","2026-05-29",{"date":175,"type":38},"2026-06-02",{"date":177,"type":38},"2025-03-20",{"date":179,"type":24},"2028-12-01",{"name":181,"class":98},"University of Utah",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":25,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":46},"100351774","phase-1-benefits-of-oxytocin-in-obstructive-sleep-apnea-osa-patients-using-continuous-positive-airway-pressure-cpap-machine-100351774","NCT03860233","Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine","Benefits of Oxytocin in OSA Patients Using CPAP","Inclusion Criteria:\n\n* Men or women 18 years of age or older.\n\nExclusion Criteria:\n\n* subjects not willing to or otherwise unable to use CPAP for treatment of OSA.\n* Presence of other sleep disorders\n* Pregnant or breastfeeding women\n* Women of child-bearing age (WOCBA) not willing or unable to use an accepted method to avoid pregnancy for the entire duration of the study\n* Prisoners or subjects who are involuntarily incarcerated\n* Subjects who are compulsorily detain or treatment of either a psychiatric or physical (i.e. infectious disease) illness\n* Patients unable to give consent because of a language barrier, or other reason.",{"count":190,"type":24},40,[27],"This study will investigate if an intra-nasal nose spray of the drug oxytocin can decrease the amount of pressure needed from the automatic Continuous Positive Airway Pressure (CPAP) device while sleeping decreasing some of the harmful effects of low oxygen in people with sleep apnea.\n\nThis study will last 35 nights and involves spending three nights in the sleep lab at George Washington University. There are no additional costs to participants and no compensation for being involved in the study.",[31,194],"Sleep Apnea, Obstructive",[196,197,198],"Continuous Positive Airway Pressure","CPAP","Oxytocin","2026-04-28",{"date":201,"type":38},"2026-05-04",{"date":203,"type":38},"2019-03-04",{"date":205,"type":24},"2026-12-31",{"name":207,"class":98},"Vivek Jain",{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":25,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":46},"100305377","phase-1-cerebral-blood-flow-and-ventilatory-responses-during-sleep-in-normoxia-and-intermittent-hypoxia-100305377","NCT03255408","Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia","Role of Cerebral Blood Flow on Ventilatory Stability During Sleep in Normoxia and Intermittent Hypoxia","Inclusion Criteria:\n\n* Healthy adults\n* 18 - 45 years of age\n* Living in Calgary for the past one year\n* Have no medical condition or should not be taking any blood pressure medications.\n* The participant should not be lactose intolerant\n\nExclusion Criteria:\n\n* Cerebrovascular, cardio-respiratory, renal and metabolic diseases\n* Bleeding disorders and upper gastrointestinal diseases e.g. peptic ulcer disease\n* Pregnancy, obese and sleep-disordered breathing\n* Drug allergies to non-steroidal anti-inflammatories\n* Currently smoking","45 Years",{"count":217,"type":24},12,[27,28],"A prospective double blind, placebo-controlled, randomized cross-over trial to evaluate the effect of lowering cerebral blood flow on the ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses).",[221,222,31,223,224,225,226,227],"Obstructive Sleep Apnea of Adult","Hypoxia, Brain","Sleep Disorder","Stroke","Blood Pressure","Endothelial Dysfunction","Oxidative Stress","2026-04-27",{"date":230,"type":38},"2026-05-01",{"date":232,"type":38},"2023-01-01",{"date":234,"type":24},"2027-12-30",{"name":236,"class":98},"University of Calgary",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":25,"phases":247,"briefSummary":248,"conditions":249,"keywords":252,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":46},"100398714","normal-pressure-hydrocephalus-and-sleep-apnea-100398714","NCT04471740","Normal Pressure Hydrocephalus and Sleep Apnea","Normal-pressure Hydrocephalus. Relationship Between Sleep Apnea and Intracranial and Intraabdominal Pressures. Outcome Prognostic Factors in CSF Shunting. Features Guiding to Implant a Ventricle-peritoneal Versus a Ventriculo-atrial Shunt","NPH\u002FOSA","Inclusion Criteria:\n\n* Clinical condition compatible with normal-pressure hydrocephalus\n\nExclusion Criteria:\n\n* Cerebral vascular disease\n* Dementia not due to normal-pressure hydrocephalus\n* Parkinson's disease",{"count":246,"type":24},30,[78],"Normal-pressure hydrocephalus is associated with increases in the intracranial pressure during the night sleep. Sleep apnea also increases the intracranial pressure during the apneic spells. When patients are operated the distal part of the shunt is inserted inside the abdominal cavity, which pressure also increases during the sleep apnea episodes. this is particularly important considering that the recumbent position used to sleep further increases the intraabdominal pressure and that impairs the CSF drainage through the shunt system. The purpose of this study is to analyze the intracranial and intraabdominal pressures during the sleep, particularly during the sleep apnea episodes to see which shunt should be used, to which cavity should be drained (peritoneum or heart) and if correcting the sleep apnea has some positive result on the hydrocephalus symptoms.",[250,31,251],"Normal Pressure Hydrocephalus","Cerebrospinal Fluid Shunt Occlusion",[253,254,255,256,257],"Normal pressure hydrocephalus","Sleep apnea","CSF shunt diversion","Ventriculo-peritoneal shunt","Ventriculo-atrial shunt","2026-04-18",{"date":260,"type":38},"2026-04-22",{"date":262,"type":38},"2020-07-02",{"date":264,"type":24},"2029-12",{"name":266,"class":98},"University of Valencia",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":274,"targetDuration":4,"studyType":25,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":46},"100480445","effect-of-hypercapnia-treatment-on-respiratory-recovery-after-spinal-cord-injury-100480445","NCT05536076","Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury","RECOV2SCI","Inclusion Criteria:\n\n* Adult patients with chronic SCI\u002FD (\\>6 months post-injury)\n* American Spinal Injury Association (ASIA) classification A-D who have evidence of SDB (excluding those with no evidence of a neurologic deficit based on ASIA classification)\n* Able-bodied patients (without SCI\u002FD0 who have OSA.\n\nExclusion Criteria:\n\n* Receiving continuous mechanical ventilation (except PAP therapy which is considered usual treatment for SDB\n* Severe congestive heart failure with ejection fraction \\\u003C35%\n* Recent health event that may affect sleep\n* stroke\n* acute myocardial infarction\n* recent surgery\n* hospitalization\n* Alcohol or substance abuse (\\\u003C90 days sobriety)\n* Self-described as too ill to engage in study procedures\n* Evidence of hypercapnia on spontaneous breathing (end-tidal CO2 \\>50 mmHg)\n* Unable to provide self-consent for participation",{"count":246,"type":24},[78],"It is estimated that 1,275,000 people in the United States alone live with spinal cord injury, including around 100,000 Veterans with spinal cord injury, making the V.A. the largest integrated health care system in the world for spinal cord injuries injury care. New therapies are needed to prevent the morbidities and mortalities associated with the high prevalence of respiratory disorders in Veterans with spinal cord injury. The current research project and future studies would set the base for developing innovative therapies for this disorder. This proposal addresses a new therapeutic intervention for sleep apnea in spinal cord injury. The investigators hypothesized that daily hypercapnia treatments improve respiratory symptoms and alleviate sleep apnea in patients with chronic spinal cord injury. The investigators will perform a pilot study to examine the impact of daily hypercapnia treatments for-two week durations among Veterans with spinal cord injury. The investigators believe that this novel approach to treating sleep apnea and will yield significant new knowledge that improves the health and quality of life of these patients.",[31,278,279],"SCI\u002FD","Hypercapnia",[254,278,279],"2026-03-27",{"date":283,"type":38},"2026-04-02",{"date":285,"type":38},"2023-03-01",{"date":287,"type":24},"2027-02-28",{"name":44,"class":45},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":298,"phases":4,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":46},"100628763","validity-and-reliability-of-the-6-minute-pegboard-and-ring-test-6pbrt-in-adults-with-obstructive-sleep-apnea-syndrome-100628763","NCT07465874","Validity and Reliability of the 6-Minute Pegboard and Ring Test (6PBRT) in Adults With Obstructive Sleep Apnea Syndrome","Validity and Reliability of the 6-Minute Pegboard and Ring Test (6PBRT) in Adults With Obstructive Sleep Apnea: A Polysomnography-Based Methodological Study","Inclusion Criteria:\n\n* Being between 18 and 65 years of age\n\nHaving a diagnosis of obstructive sleep apnea (OSA) confirmed by polysomnography\n\nHaving sufficient cognitive ability to understand and follow the test instructions\n\nHaving adequate shoulder range of motion to elevate the upper extremities above head level for performing the 6PBRT\n\nVoluntarily agreeing to participate in the study and providing written informed consent\n\nExclusion Criteria:\n\n* Presence of neurological diseases that may significantly affect upper extremity function (e.g., stroke, multiple sclerosis, peripheral neuropathy)\n\nSevere orthopedic conditions limiting upper extremity movement (e.g., advanced shoulder pathology, recent surgery, severe contracture)\n\nUnstable cardiopulmonary conditions (e.g., recent myocardial infarction, decompensated heart failure, uncontrolled arrhythmia, acute COPD\u002Fasthma exacerbation)\n\nAcute infection, febrile illness, or severe clinical exacerbation within the last 4 weeks\n\nPain severe enough to interfere with the test or any clinical condition preventing the safe administration of the test","65 Years",{"count":164,"type":24},"OBSERVATIONAL","Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder characterized by recurrent upper airway obstruction during sleep, leading to intermittent hypoxia and sleep fragmentation. In addition to its well-known cardiometabolic consequences, OSA may negatively affect functional capacity and daily activity performance. However, upper extremity functional capacity in individuals with OSA has not been adequately evaluated.\n\nThe 6-Minute Pegboard and Ring Test (6PBRT) is a functional test designed to assess upper extremity functional capacity during unsupported arm activity. Although the test has been widely used in respiratory diseases, its measurement properties have not yet been evaluated in patients with OSA.\n\nThe aim of this study is to investigate the validity and reliability of the 6PBRT in adults diagnosed with obstructive sleep apnea using polysomnography. Participants with OSA will undergo polysomnographic evaluation and complete the 6PBRT. Test-retest reliability will be assessed by repeating the test under the same conditions. The relationship between 6PBRT performance and polysomnographic parameters (AHI, ODI, minimum SpO₂ and T90) will also be examined. In addition, associations between 6PBRT performance and clinical scales such as the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire will be analyzed.\n\nThe findings of this study are expected to provide evidence regarding the measurement properties of the 6PBRT in individuals with OSA and contribute to the clinical assessment of upper extremity functional capacity in this population.",[140,31],[302,303,304,140,305],"6-Minute Pegboard and Ring Test","Upper Extremity Functional Capacity","Polysomnography","Functional Performance","2026-03-06",{"date":308,"type":38},"2026-03-12",{"date":310,"type":24},"2026-03-23",{"date":312,"type":24},"2026-11-15",{"name":314,"class":98},"Mardin Artuklu University",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":296,"enrollmentInfo":323,"targetDuration":4,"studyType":298,"phases":4,"briefSummary":325,"conditions":326,"keywords":334,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":46},"100517290","comorbidities-resolution-after-mgb-surgery-and-change-in-body-composition-100517290","NCT06015620","Comorbidities Resolution After MGB Surgery and Change in Body Composition","CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)","MOGAMBO","Inclusion Criteria:\n\n* All patients undergoing laparoscopic MGB surgery for morbid obesity and it's associated comorbidities\n\nExclusion Criteria:\n\n* Patients not giving consent for the study\n* All patients who were undergoing a redo-procedure for recurrence were excluded from the study",{"count":324,"type":24},35,"This observational study aims to learn about the correlation between the improving comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in body composition in morbidly obese patients. The main questions it aims to answer are:\n\nTo study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.\n\nOther objectives are:\n\n* Changes in the parameters of the metabolic syndrome after surgery\n* Changes in the cardiovascular risk biomarkers after metabolic surgery\n* Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits.\n\nType of Study: An observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. No separate experimental interventions will be done in the study for the participants.",[327,328,31,329,330,331,332,333],"Morbid Obesity","Type2diabetes","Hypothyroidism","Hypertension","Lipid Disorder","Non-Alcoholic Fatty Liver Disease","Chronic Venous Hypertension With Ulcer",[335,336,337,338,339,340,341,342,343],"morbid obesity","OSA","mini gastric bypass","metabolic surgery","polysomnography","metabolic syndrome","DEXA scan","bioelectrical impedance","body composition","2026-02-16",{"date":346,"type":38},"2026-02-18",{"date":348,"type":38},"2023-09-01",{"date":350,"type":24},"2027-03-30",{"name":352,"class":98},"All India Institute of Medical Sciences, Bhubaneswar",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":361,"targetDuration":363,"studyType":298,"phases":4,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":46},"100555622","spanish-registry-of-patients-with-sleep-apnea-and-daytime-sleepiness-100555622","NCT06514482","Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness","Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna","HYPNOSA","Inclusion Criteria:\n\n* Patients who come to the sleep consultation for sleep study results for suspected OSA.\n* Patients older than 18 years.\n* Signature of the informed consent.\n\nExclusion Criteria:\n\n* Psycho-physical inability to complete questionnaires.\n* Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleep deprivation (less than 6h\u002Fday), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) and restless legs syndrome.\n* Patients with \\> 50% central apnea or presence of Cheyne-Stokes respiration (CSRsp).\n* A medical history that may interfere with the objectives of the study or that in the judgment of the investigator compromises the conclusions.\n* Any medical, social or geographical factor that may endanger the patient compliance. (eg, alcohol consumption (more than 80 g\u002Fday in men and more than 60 gr \u002F day in women), absence of stable habitual residence, disorientation or non-compliance history).\n* Any process, cardiovascular or not, that limits life expectancy to less than one year.",{"count":362,"type":24},1000,"2 Years","Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out.\n\nOSA patients will be evaluated at baseline, 6, 12, and 24 months.",[31],[367],"CPAP, residual sleepiness, OSA","2026-02-12",{"date":370,"type":38},"2026-02-17",{"date":372,"type":38},"2022-10-28",{"date":374,"type":24},"2028-12-31",{"name":376,"class":98},"Hospital San Pedro de Logroño",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":25,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":46},"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":386,"type":24},45,[78],"This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.",[390,31],"Sleep Disordered Breathing (SDB)","2025-11-17",{"date":393,"type":38},"2025-11-21",{"date":395,"type":38},"2025-07-30",{"date":397,"type":24},"2027-12-31",{"name":399,"class":400},"Lunair Medical","INDUSTRY",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":19,"minAge":408,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":25,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":422},"100558866","janus-ii-feasibility-100558866","NCT06556693","Janus II Feasibility","Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy","Inclusion Criteria:\n\n* Severe sleep disordered breathing\n* Expected to tolerate study procedures\n* No heart failure or medically stable heart failure\n\nExclusion Criteria:\n\n* Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval\n* History of severe COPD or pulmonary arterial hypertension\n* Current or previous history of nerve injury or palsy\n* Prior cervical surgeries or radiation treatment to head region\n* Known need for an MRI\n* History of psychosis or severe bipolar disorder\n* Active Infection or sepsis within 30 days of enrollment\n* Currently on kidney dialysis or significantly reduced kidney function\n* Hemoglobin less than 8g\u002Fdl\n* Pacemaker dependance\n* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months\n* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures\n* Allergy to contrast dye unless can be prophylactically treated\n* Known pregnancy or planning to become pregnant","22 Years",{"count":190,"type":24},[78],"The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.",[31],"2025-10-28",{"date":415,"type":38},"2025-10-29",{"date":417,"type":38},"2025-08-12",{"date":419,"type":24},"2034-12",{"name":421,"class":400},"Zoll Medical Corporation",3,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":18,"sex":19,"minAge":430,"maxAge":21,"enrollmentInfo":431,"targetDuration":4,"studyType":25,"phases":432,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":46},"100263018","phase-4-sleep-apnea-in-elderly-100263018","NCT02703220","Sleep Apnea in Elderly","Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly","Inclusion Criteria:\n\n* Adults who are 60 years old and older, with mild to moderate sleep apnea with AHI \\>\u002F=5 to 20\u002Fhr with central, obstructive, mixed apneas and hypopneas.\n* For the finasteride protocol elderly men with above criteria will be enrolled.\n\nExclusion Criteria:\n\n* Patients with severe sleep apnea (AHI\\>20\u002Fhr)\n* Patients with history of prostate cancer\n* Males with hypogonadism\n* History of cardiac disease, including myocardial infarction\n* Bypass surgery\n* Atrial and ventricular tachy-bradycardias\n* Systolic congestive heart failure and Cheyne-Stokes respiration\n* Current unstable angina\n* Stroke\n* Schizophrenia\n* Untreated hypothyroidism\n* Seizure disorder\n* Preexisting renal failure and liver disorders\n* Failure to give informed consent.\n* Patients with significant pulmonary diseases by history and abnormal pulmonary function testing, including moderate obstructive\u002Frestrictive lung\u002Fchest wall disorders with resting oxygen saturation of \\\u003C96% or on supplemental oxygen\n* Patients on certain medications including:\n\n  * study drugs\n  * sympathomimetics\u002Fparasympathomimetics or their respective blockers\n  * narcotics\n  * antidepressants\n  * anti-psychotic agents\n  * other central nervous system (CNS) altering medications\n  * current alcohol, tobacco or recreational drug use\n* Patients with BMI\\>34kg\u002Fm2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control\n* Elderly with unstable gait or mobility issues that may preclude safe participation\n* Individuals with allergy to finasteride or acetazolamide will be excluded from the specific protocol\n* Pregnant women","60 Years",{"count":54,"type":24},[56],"Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and leads to increased morbidity and mortality in this population. The proposal aims to identity whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in the elderly via different mechanisms. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea in the elderly. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea. A cumulative effect of the investigators' research will fulfill the long-term goal of improving the quality of life of elderly Veterans suffering from sleep apnea and its potential life-threatening complications.",[31,435],"Elderly Adults",[114,437,438,439,440,441,442,443],"chemoresponsiveness","cerebrovascular response","hyperoxia","acetazolamide","finasteride","apneic threshold","carbon-dioxide reserve","2025-09-17",{"date":446,"type":38},"2025-09-23",{"date":448,"type":38},"2015-07-03",{"date":450,"type":24},"2026-07-31",{"name":44,"class":45},{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":460,"enrollmentInfo":461,"targetDuration":463,"studyType":298,"phases":4,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":126},"100541633","hypoglossal-nerve-stimulation-therapy-in-patients-with-obstructive-sleep-apnea-belgian-registry-100541633","NCT06332404","Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry","Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry","B-HNS","Inclusion Criteria:\n\nAny patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS implantation if he\u002Fshe meets the following criteria:\n\n* At least 18 years old at the time of implantation\n* The patient suffers from moderate to severe OSA (15 events\u002Fh ≤ AHI ≤ 65 events\u002Fh)\n* The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and\u002For mandibular advancement device (MAD) therapy\n* Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE)\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>32 kg\u002Fm².\n* Combined mixed and central AHI is more than 25% of the total AHI\n* Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS\n* Patients with severely impaired neurological control over the upper airway\n* Pregnancy\n* Surgery performed on the soft palate in the past three months before implantation.","99 Years",{"count":462,"type":24},225,"5 Years","Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.\n\nThe aim is to create a multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.",[140,31,466],"Apnea",[468,469,470],"hypoglossal nerve stimulation","registry","routine clinical care","2025-09-12",{"date":473,"type":38},"2025-09-15",{"date":475,"type":38},"2024-04-18",{"date":477,"type":24},"2034-04",{"name":479,"class":98},"University Hospital, Antwerp",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":25,"phases":489,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":422},"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":23,"type":24},[78],"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.",[390,31],[493,494,495,496],"Sleep Scoring","Sleep Stages","Arousals","Neural Network Classifier","2025-09-10",{"date":499,"type":38},"2025-09-16",{"date":501,"type":24},"2025-09",{"date":503,"type":24},"2025-12",{"name":505,"class":400},"Pathway Medtech, LLC.",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":460,"enrollmentInfo":514,"targetDuration":4,"studyType":298,"phases":4,"briefSummary":516,"conditions":517,"keywords":518,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":46},"100559117","non-inferiority-analysis-of-two-titration-methods-for-hypoglossal-nerve-stimulation-therapy-100559117","NCT06559956","Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy","Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea","DOT-PSG","Inclusion Criteria:\n\n* Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)\n* Cohort 1: Patients that previously underwent an overnight titration PSG as part of their routine clinical care at the Antwerp University Hospital\n* Cohort 2: Patients that recently underwent or will be undergoing a daytime titration PSG at the Antwerp University Hospital\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Not able to understand the language of the questionnaires",{"count":515,"type":24},110,"Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options.\n\nApproximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and\u002For snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated.\n\nThe aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.",[140,31,466],[468,519],"titration polysomnography","2025-09-08",{"date":497,"type":38},{"date":523,"type":38},"2024-08-27",{"date":525,"type":24},"2028-07",{"name":479,"class":98},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":25,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":126},"100486324","phase-4-adipose-dysfunction-imaging-physiology-and-outcomes-with-sodium-glucose-cotransporter-2-inhibitor-sglt2i-for-sleep-apnea-the-adiposa-study-100486324","NCT05612594","Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study","Adipose Dysfunction, Imaging, Physiology, and Outcomes With SGLT2i's for Sleep Apnea: The ADIPOSA Study","ADIPOSA","Inclusion Criteria:\n\n* Able to provide informed consent and stated willingness to comply with all study procedures and availability for the duration of the study\n* Overweight or obese (body mass index 25-40 kg\u002Fm2)\n* Clinically confirmed diagnosis of obstructive sleep apnea by one of the following methods:\n\n  a. Polysomnography: AHI ≥15\u002Fhour sleep or b. Home sleep apnea testing: Respiratory event index (REI) ≥15\u002Fhour sleep\n* AHI: apnea-hypopnea index (apneas + hypopneas \u002F total sleep time in hours)\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Known non-OSA related conditions associated with sleep disordered breathing (e.g., central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder)\n* Use of sleep-inducing medications (e.g. benzodiazepines, opiates, barbiturates)\n* Type 1 diabetes mellitus\n* History of diabetic ketoacidosis\n* Known hypersensitivity reaction to bexagliflozin or any of its constituents or any contraindication to bexagliflozin use\n* Severe, recurrent urinary tract or genital mycotic infections\n* eGFR\\\u003C30mL\u002Fmin\u002F1.73m2 at time of or within 4 weeks of enrollment in the study\n* Unable to complete\u002Ftolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.\n* Language barrier, mental incapacity, unwillingness or inability to understand.\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant.\n* Currently or planning to take a SGLT2i prior to or during enrollment in the study\n* Currently or planning to follow a ketogenic diet pattern (\"keto diet) prior to or during enrollment in the study\n* Currently or planning to follow an active weight loss program (including but not limited to use of supplements, medications, or surgery) prior to or during enrollment in the study\n* Currently or planning to follow an intermittent fasting diet plan prior to or during enrollment in the study\n* Currently or planning to take a GLP-1 receptor agonist prior to or during enrollment in the study .\n* Existing lower limb ulcer (due to diabetes or any cause)\n* Existing severe peripheral arterial disease with intermittent claudication and\u002For prior lower limb revascularization procedure\n* Concomitant administration of UGT inducers\n* Severe liver disease",{"count":536,"type":24},164,[56],"The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug).\n\nThe main question it aims to answer is:\n\n* If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants\n* If improvement in clinical measures are because of improvement in the anatomic and physiologic traits.\n\nParticipants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better.",[31],"2025-09-03",{"date":542,"type":38},"2025-09-11",{"date":544,"type":38},"2024-03-27",{"date":546,"type":24},"2027-09",{"name":154,"class":98},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":296,"enrollmentInfo":555,"targetDuration":4,"studyType":25,"phases":557,"briefSummary":558,"conditions":559,"keywords":562,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":46},"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.",{"count":556,"type":24},36,[78],"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.",[560,31,561],"Sleep-disordered Breathing (SDB)","Sleep Quality",[563,564,254,565],"Pulse Oximeters","SpO2","postive air pressure","2025-08-13",{"date":568,"type":38},"2025-08-17",{"date":570,"type":24},"2025-09-01",{"date":572,"type":24},"2025-12-31",{"name":505,"class":400},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":19,"minAge":580,"maxAge":20,"enrollmentInfo":581,"targetDuration":4,"studyType":298,"phases":4,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":126},"100364954","clinical-evaluation-of-a-paediatric-sleep-diagnosis-technology-100364954","NCT04031950","Clinical Evaluation of a Paediatric Sleep Diagnosis Technology","Inclusion Criteria:\n\n* Children older than one year old\n* Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.\n\nExclusion Criteria:\n\n* Patients whose parents\u002Flegal guardians\u002Fcarers are not fluent in English, or who have special communication needs.\n* Known allergy to the adhesive dressing.\n* Patients with physical or mental impairments who would be too distressed with additional sensors on themselves.\n* Patients with not enough space on the neck area to fit the sensor.\n* Clinical problem in the area in which the device will be attached, eg skin condition","1 Year",{"count":582,"type":24},200,"The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.\n\nThe Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.",[31],{"date":586,"type":38},"2025-08-15",{"date":588,"type":38},"2020-02-19",{"date":590,"type":24},"2025-12-30",{"name":592,"class":400},"Acurable Ltd.",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":19,"minAge":600,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":25,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":610,"leadSponsor":612,"locationsCount":4},"100600278","assessing-the-performance-of-wesper-lab-for-obstructive-and-central-sleep-apnea-100600278","NCT07095413","Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea","Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea Diagnosis in Adult Populations","Inclusion Criteria:\n\n* Be at least 21 years of age\n* Have a referral to the study site from a physician to complete an overnight polysomnogram test for sleep apnea detection or follow-up.\n* Be willing and able to wear two Wesper Lab patches and an FDA-cleared pulse oximeter in conjunction with a polysomnogram, for a single night.\n* Be able and voluntarily willing to sign a written informed consent form prior to the initiation of any study procedures. Adult patients unable to provide written informed consent on their own behalf will not be eligible for the study.\n\nExclusion Criteria:\n\n* Women who are pregnant, trying to get pregnant or who have a positive urine pregnancy test on the day of the study.\n* Women who are breast-feeding\n* History of severe insomnia\n* Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.","21 Years",{"count":54,"type":24},[78],"The goal of this clinical trial is to evaluate the effectiveness of the Wesper Lab home sleep apnea test as a tool to aid in the diagnosis of sleep apnea in adult patients (age ≥21 years) who are recommended for an overnight polysomnography (PSG) evaluation. The main questions it aims to answer are:\n\n1. Is Wesper Lab home sleep apnea test as accurate as an in-laboratory sleep study (polysomnography) for the diagnosis of obstructive and central sleep apnea?\n2. Is Wesper Lab accurate in a wide range of body types and skin types?\n\nParticipants will:\n\n1. Provide informed consent and complete a brief medical history.\n2. Undergo an overnight polysomnography sleep study while wearing two Wesper Lab patches and a compatible pulse oximeter.\n3. Have a follow-up communication within 5 days post-study to assess any adverse events.",[31,194,605],"Sleep Apnea, Central","2025-07-23",{"date":608,"type":38},"2025-07-31",{"date":570,"type":24},{"date":611,"type":24},"2026-02-01",{"name":613,"class":400},"Wesper Inc",{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":25,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":46},"100587641","phase-3-a-study-of-ibi362-in-chinese-subjects-with-obstructive-sleep-apnea-and-bmi28-kgm2-100587641","NCT06931028","A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg\u002Fm2","A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of IBI362 in Chinese Subjects With Moderate-to-Severe Obstructive Sleep Apnea and BMI≥28 kg\u002Fm2 (GLORY-OSA)","Inclusion Criteria:\n\n* For PAP s: Subjects who have received positive airway pressure (PAP) therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study.\n* For non-PAP s:Subjects who are unable or unwilling to undergo PAP therapy. PAP must not have been used for at least 4 weeks prior to screening.\n* For all subjects:\n\n  1. Age ≥18 years at the time of signing informed consent.\n  2. Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events\u002Fhour.\n  3. Body mass index (BMI) ≥28.0 kg\u002Fm² at screening.\n\nExclusion Criteria:\n\nFor PAPs：\n\n* Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study\n* Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study For all subjects：\n* Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM).\n* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline\n* Have significant craniofacial abnormalities that may affect breathing at baseline\n* Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.\n* Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.\n* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.\n* Have achieved a \\>5% change in body weight through diet and exercise alone for at least 12 weeks prior to screening.",{"count":622,"type":24},260,[137],"This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg\u002Fm2. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.",[31,626,627],"Obstructive","Obesity","2025-06-25",{"date":630,"type":38},"2025-06-29",{"date":632,"type":38},"2025-06-12",{"date":634,"type":24},"2027-06-11",{"name":636,"class":400},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":643,"eligibilityCriteria":644,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":645,"enrollmentInfo":646,"targetDuration":4,"studyType":298,"phases":4,"briefSummary":648,"conditions":649,"keywords":650,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":46},"100578220","new-approach-in-the-study-of-the-autonomic-nervous-system-through-cardiac-variability-in-sleep-apnea-syndrome-100578220","NCT06808464","New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.","Evaluation of Autonomic Activity in REM Sleep by a New Marker of Cardiac Variability in Subjects With Severe Obstructive Sleep Apnea Hypopnea Syndrome","HRVSAS","Inclusion Criteria:\n\n* Group healthy subjects - 1): absence of sleep disorder referenced in the ICSD-3.\n\n  * Epworth Sleep Scale \\\u003C 11\n  * Pittsburgh Quality Sleep Index \\\u003C 6\n  * Berlin Questionnaire: \\\u003C 2 positive categories\n  * STOP BANG \\\u003C3\n  * HADS normal\n  * No RLS\n* Group 2 (subjects with severe SAS - 2): AHI \\> 30\u002Fh obstructive\n\nExclusion Criteria:\n\nNon-inclusion criteria:\n\n* Cardiac rhythm disorder\n* Neurological or psychiatric pathology impacting on ANS\n* Control group (healthy subjects - 1)\n\n  * Complaint of sleep disorder\n  * Known sleep disorder\n* Experimental group (subjects with severe SAS - 2):\n\n  o Associated sleep pathology at diagnosis of severe SAS\n* Administrative reasons:\n\n  * Unable to receive informed information,\n  * Unable to participate in the entire study\n  * Lack of social security coverage\n  * Refusal to sign consent Exclusion criteria\n* Control group (healthy subjects - 1):\n\n  * Sleep pathology detected by polysomnography\n  * Total sleep time less than 4 hours\n  * Recording technically not usable","64 Years",{"count":647,"type":24},97,"The main objective of this study is to compare the different variations of the cardiac variability index measured thanks to the technique developed by the CIC-IT between subjects with severe SAS and healthy subjects with sleep pathology.\n\nIn a first step, these two groups will be compared in REM sleep phase because it is the period during which the risk of sleep apnea syndrome is the highest. In a second step, the same methodology will be applied for the other sleep phases and correlations will be established with the other markers of cardiac variability (HRV) already known. This will allow to validate a reliable method of screening for SAS that is more accessible in ambulatory settings by means of a machine learning system based on artificial intelligence",[31],[651,652,653,654,655],"Sleep apnea hypopnea syndrome","Autonomic nervous system","Cardiac variability","Automatic detection","Machine Learning","2025-05-22",{"date":658,"type":38},"2025-05-29",{"date":660,"type":38},"2025-05-14",{"date":662,"type":24},"2027-02",{"name":664,"class":98},"University Hospital, Lille"]