[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obstructive-sleep-apnea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obstructive-sleep-apnea":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,187,0,25,[9,44,70,99,120,139,166,196,230,257,285,306,347,373,399,418,444,468,493,518,544,562,582,601,622],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100616093","myofunctional-therapy-for-obstructive-sleep-apnea-100616093",false,"NCT07301125","Myofunctional Therapy for Obstructive Sleep Apnea","Inclusion Criteria:\n\n* Adults aged 18-65\n* New diagnosis of OSA (AHI ≥ 5) or failure of first-line OSA treatment\n* Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months\n\nExclusion Criteria:\n\n* Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia)\n* Severe nasal obstruction\n* Severe ankyloglossia\n* Craniofacial abnormality\n* Severe pulmonary disease\n* Severe post-traumatic stress disorder (PCL-5 \\&gt; 33)\n* Very severe insomnia (ISI \\&gt; 22)\n* Body mass index (BMI) ≥30 kg\u002Fm2.\n* History of TBI\n* Known oropharyngeal or esophageal dysphagia\n* Pregnancy\n* Allergy to topical anesthetic\n* Inability to fast for 6 hours\n* Recent facial trauma\n* Recent nasal, pharyngeal, laryngeal, or esophageal surgery\n* Known nasal, pharyngeal or esophageal obstruction\n* Current upper respiratory infection\n* Insufficient internet\u002Fcomputer access to participate in remote study visit\n* Severe excessive daytime sleepiness (risk of motor vehicle accidents)\n* Heart failure, recent stroke, heart attack, etc.\n* Nasal Obstruction Symptom Evaluation (NOSE) Scale \\&gt;15","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to explore a new way to examine the function of the muscles using a technique called high-resolution manometry. The study will enroll 30 adults with OSA, all of whom will use the myofunctional therapy (MFT) devices for 3 months. High-resolution manometry will be used to measure the amount of pressure generated by the muscles of the throat when drinking water or breathing air, both with and without the MFT devices, and before and after the MFT intervention. If successful, this method can help us understand why sleep improves after MFT.",[27],"Obstructive Sleep Apnea",[27,29,30],"Myofunctional Therapy","High-Resolution Manometry","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":21},"2026-07-15",{"date":39,"type":21},"2027-09-30",{"name":41,"class":42},"University of Minnesota","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100512527","phase-2-endotypic-traits-and-obstructive-sleep-apnea-surgery-100512527","NCT05953610","Endotypic Traits and Obstructive Sleep Apnea Surgery","Inclusion criteria are:\n\n1. age ≥21 years;\n2. moderate to severe OSA (obstructive AHI ≥ 15 events\u002Fhour);\n3. central\u002Fmixed apnea index \\\u003C5 events\u002Fhour;\n4. intolerance of positive airway pressure (defined as use \\\u003C 2 hours\u002Fnight at least 5 nights\u002Fweek);\n5. intolerance or poor candidate for oral appliance;\n6. participant has provided informed consent for palate surgery as part of their standard of care;\n7. tonsil size 0-2+ (without markedly enlarged tonsils that have high surgical success rates);\n8. DISE without evidence of complete tongue-related obstruction (reflecting poorer results with isolated palate surgery);\n9. medications stable for ≥2 months;\n10. body mass index \\\u003C35 kg\u002Fm2;\n11. absence of uncontrolled nasal obstruction;\n12. no prior pharyngeal surgery other than tonsillectomy;\n13. no neurologic, cardiac or pulmonary disorders;\n14. absence of psychiatric disorder except for treated depression or mild anxiety;\n15. no co-existing sleep disorder, such as narcolepsy, chronic insomnia, or restless legs syndrome;\n16. no use of hypnotics, anxiolytics, stimulants, or sedating antidepressants;\n17. no near-miss or prior motor vehicle crash due to sleepiness in past 12 months; and\n18. \\\u003C3 caffeinated beverages daily.\n\nExclusion criteria are:\n\n1. history of allergic reaction to either of the study drugs;\n2. subjects with prior serious allergic reaction (such as Stevens-Johnson syndrome) to sulfonamides;\n3. subjects with a history of hypersensitivity to either of the two study drugs;\n4. subjects who are on high-dose aspirin therapy due to risk of severe metabolic acidosis;\n5. subjects with severe kidney disease or severe liver disease;\n6. subjects with a history of electrolyte imbalance or adrenal insufficiency (due to risks related to acetazolamide);\n7. subjects on ketoconazole or other strong CYP3A4 inhibitors (these will increase eszopiclone blood levels);\n8. pregnancy; and\n9. alcohol or substance abuse.","21 Years",{"count":52,"type":21},150,[54],"PHASE2","This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).",[27],[58,59,60],"surgery","loop gain","arousal threshold","2026-06-29",{"date":34,"type":35},{"date":64,"type":35},"2024-01-07",{"date":66,"type":21},"2028-08-31",{"name":68,"class":42},"University of California, Los Angeles",2,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100645122","cognitive-function-and-quality-of-life-in-obstructive-sleep-apnea-100645122","NCT07678918","Cognitive Function and Quality of Life in Obstructive Sleep Apnea","Correlation Between the Cognitive Function and Quality of Life in Patients With OSA","Inclusion Criteria:\n\n* Patients Group: Age \\> 18 years.\n* Patients Group: Meeting the AASM diagnostic criteria for OSA.\n* Control Group: Age and sex-matched community members related to the patients.\n* Control Group: Education level, social status, and comorbidity-matched people.\n\nExclusion Criteria:\n\n* Patients Group: OSA patients who are compliant on PAP therapy (\\> 4 hours, \\> 5 nights\u002Fweek) for ≥ 6 months.\n* Patients Group: Inability to comprehend and\u002For co-operate with the instructions provided by the investigators during neurocognitive function assessment.\n* Patients Group: History of neurological comorbidities with potential cognitive impairment (previous cerebrovascular stroke, dementia).\n* Patients Group: Patients who are maintained on medications that potentially impair cognitive performance (histamine receptor antagonist, antipsychotic, antidepressant, or mood stabilizer drugs).\n* Patients Group: Use of alcohol, or illicit drugs that interfere with cognitive function (cannabis, opioids, amphetamine or equivalents).\n* Control Group: Intermediate or high-risk of having undiagnosed OSA as assessed by the STOP-BANG questionnaire.",{"count":78,"type":21},86,"OBSERVATIONAL","Obstructive Sleep Apnea (OSA) is a common condition that disrupts normal breathing during sleep. Beyond causing daytime tiredness, OSA can also impact a person's cognitive functions, such as their attention span, memory, and problem-solving skills, which may in turn affect their overall quality of life.\n\nThe main purpose of this study is to compare the thinking and memory skills of adults recently diagnosed with OSA against a control group of healthy adults without the condition. Furthermore, the researchers aim to understand how specific cognitive challenges (like difficulty sustaining attention) relate to a patient's physical and mental well-being.\n\nParticipants in the study will undergo an overnight sleep test (diagnostic polysomnography) at a sleep clinic. Shortly after the sleep test, participants will complete a series of short, computer-based tasks designed to measure their attention, memory, and executive function. They will also be asked to fill out standard questionnaires regarding their daily sleepiness, mood, and health-related quality of life.",[27,82,83],"Cognitive Impairment","Quality of Life",[27,85,83,86,87,88,89],"Cognitive Function","Neurocognitive Impairment","Psychomotor Vigilance","Polysomnography","SF-36","NOT_YET_RECRUITING","2026-06-25",{"date":34,"type":35},{"date":94,"type":21},"2026-08",{"date":96,"type":21},"2027-09",{"name":98,"class":42},"Assiut University",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":108,"studyType":79,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":43},"100625819","prospective-evaluation-of-new-metrics-to-assess-cardiovascular-remodeling-in-obstructive-sleep-apnea-100625819","NCT07427589","Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea","CARDOSA","Inclusion Criteria:\n\n* AHI ≥ 15 events\u002Fhour, based on a recent (\\\u003C2 years) PSG, conducted in Antwerp University Hospital\n* Patients must be 18 years or older\n* Patients must be dutch-speaking\n* Patients must be eligible for their therapy (CPAP, MAD or HNS)\n* Willing to participate after informed consent\n\nExclusion Criteria:\n\n* Central apneas accounting for ≥25% of total apneas during baseline polysomnography\n* Patients who have received effective CPAP therapy (defined as CPAP use for ≥4 h\u002Fnight) within the previous 6 months\n* Patients with prior MAD therapy\n* Uncontrolled hypertension\n* Known cardiomyopathy\n* Significant coronary arterial disease\n* Clinically significant valvular heart disease, defined as more than mild left-sided valvular disease or more than moderate right-sided valvular disease\n* Congenital heart disease\n* Participants may be excluded if, after rescoring, outcome measures do not meet predefined criteria",{"count":107,"type":21},270,"1 Year","The goal of this prospective study is to gain insight into the endophenotypic variation in OSA, with a focus on the underlying pathophysiological traits and the cardiovascular alterations associated with the condition. To capture the variability in OSA endophenotypes, novel metrics that extend beyond the AHI will be considered, with particular attention to the sleep-apnea-specific hypoxic burden, the sleep-apnea-specific heart rate response, and pulse wave amplitude drops (PWADs). Since the impact of treatment on cardiovascular parameters remains an important point of interest, the effects of different treatment modalities on cardiovascular changes will be investigated, including continuous positive airway pressure (CPAP), mandibular advancement devices (MADs), and hypoglossal nerve stimulation.",[27,111],"Cardiovascular (CV) Risk","2026-06-24",{"date":61,"type":35},{"date":115,"type":35},"2026-06-10",{"date":117,"type":21},"2029-12",{"name":119,"class":42},"University Hospital, Antwerp",{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":43},"100477766","ansa-cervicalis-and-hypoglossal-nerve-stimulation-in-osa-100477766","NCT05501236","Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA","Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea","Inclusion Criteria:\n\n1. Consenting adults with BMI≥ 25 and ≤ 40 kg\u002Fm2\n2. Obstructive sleep apnea with an AHI between 20 and 80 events\u002Fhr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.\n\nExclusion Criteria:\n\n1. Chronic use of opiate medications, illicit drug use, or alcohol dependency\n2. Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)\n3. Clinical history or evidence of cardiopulmonary disease (or oxygen use), liver, renal, immunodeficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia.\n4. Prior upper airway reconstructive surgery excluding tonsillectomy (e.g., cleft palate repair, uvulopalatopharyngoplasty)\n5. Indwelling neurostimulation device (e.g. cardiac pacemaker, spinal, vagal, or hypoglossal nerve stimulator)",{"count":128,"type":21},100,[24],"Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. The Investigators propose a study examining the physiologic effect of ansa cervicalis stimulation (ACS) alone and in combination with HNS during PSG and DISE.",[27],{"date":61,"type":35},{"date":134,"type":35},"2022-11-03",{"date":136,"type":21},"2027-11-30",{"name":138,"class":42},"Vanderbilt University Medical Center",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":16,"minAge":146,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":69},"100618412","bi-lateral-hgn-therapy-in-real-world-patients--post-approval-research-investigation-100618412","NCT07331285","Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation","BREATHE","Inclusion Criteria:\n\n1. Have an apnea-hypopnea index (AHI) greater than or equal to 15 and less than or equal to 65, measured on a full-night PSG performed no earlier than 2 years prior to enrollment (AHI4 and ODI4 available).\n2. Be adults 22 years of age and older.\n3. Have been confirmed to have failed, not tolerated, or be ineligible to be treated with current standard of care treatments for moderate to severe OSA.\n4. Have pursued insurance pre-authorization for Genio® Therapy, recognizing that pre-authorization does not ensure payment, or demonstrate willingness to assume any out-of-pocket costs. The sponsor will not be responsible for treatment-related charges.\n5. Agree to participate in the study and voluntarily sign and date an informed consent form.\n6. Be willing and capable of complying with all study requirements, including specific lifestyle considerations, performing all follow-up visits, evaluation procedures and questionnaires for the whole duration of the trial.\n7. Have a result of a Drug- Induced Sleep Endoscopy (DISE), no earlier than 2 years prior to enrollment.\n\nExclusion Criteria:\n\n1. Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.\n2. Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.\n3. Have an implantable device which may be susceptible to unintended interaction with the Genio® System 2.1.\n4. Women who are pregnant, planning to become pregnant or breastfeeding.\n5. Any condition or procedure that has compromised neurological control of the upper airway.\n6. Be part of the populations for which the safety and effectiveness of the Genio® System 2.1 has not been fully assessed:\n\n   1. Patients below 22 or above 75 years of age.\n   2. Patients with a Body Mass Index (BMI) above 32 kg\u002Fm2.\n   3. Patients with an Apnea Hypopnea Index (AHI) below 15 or over 65 events\u002Fhr.\n   4. Patients with Complete Concentric Collapse (CCC) at the soft palate level.","22 Years",{"count":148,"type":21},229,"The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed\u002Frefused PAP treatments.",[27],[152,153,154,155],"OSA","Hypoglossal Nerve Stimulation","Genio","obstructive sleep apnea","2026-06-18",{"date":158,"type":35},"2026-06-22",{"date":160,"type":21},"2026-06",{"date":162,"type":21},"2032-10",{"name":164,"class":165},"Nyxoah Inc.","INDUSTRY",{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":16,"minAge":174,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":192,"leadSponsor":194,"locationsCount":43},"100641242","effects-of-a-pacifier-on-obstructive-sleep-apnea-and-its-repercussions-in-infants-with-down-syndrome-100641242","NCT07658053","Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome","Effects of a Pacifier on the Development of Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome","TET21","Inclusion Criteria:\n\n* Group 1 (infants with CURAPROX pacifier)\n\n  * Age 1 month (±1 week)\n  * Children diagnosed with free and homogeneous trisomy 21\n  * For whom a consultation is planned at \\~1 month in the department of genetics\n  * Affiliated to a social security scheme\n  * With informed consent of the 2 legal representatives\n* Group 2 (infants without CURAPROX pacifier)\n\n  * Infants included in the OMF21 study (sponsored by HCL, n°ID-RCB 2025-A01900-49, approved by ethical committee Nord-Ouest IV on October 9th 2025)\n  * With informed consent of the 2 legal representatives for re-use of the data\n\nExclusion Criteria:\n\n* Group 1 (infants with CURAPROX pacifier)\n\n  * Diagnosed with mosaic trisomy 21\n  * Born preterm (gestation age at birth \\\u003C37 weeks)\n  * Known allergy to silicone\n  * Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies\n* Group 2 (infants without CURAPROX pacifier) - Use of the CURAPROX pacifier for ≥1 month","23 Days","38 Days",{"count":177,"type":21},50,[24],"Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals. In children, OSA can have long-term consequences on the development and on the cardiovascular system.\n\nDown Syndrome (DS) is a genetic disorder associated with intellectual disability and many comorbidities. The prevalence of OSA is particularly high in patients with DS, from infancy. In a recent study, OSA was diagnosed in 97% infants and early diagnosis and intervention from the age of 6 months was associated with better neurocognitive outcome at 3 years old. Therefore, there is a need to develop new strategies to prevent OSA early in infancy.\n\nOSA can be linked to some orofacial abnormalities presented by patients with DS. Indeed, orofacial functions and structures ca play a crucial role in OSA. For example, nose breathing allows the tongue to act as a stimulator of the transverse maxillary growth during childhood, allowing the upper airway to develop properly.\n\nThe primary objective of the present study is to evaluate the effects of a pacifier used by infants with Down Syndrome (from the age of 1 months) on the severity of OSA at the age of 6 months, by comparing a group of infants with the pacifier vs a group of infants without the pacifier.\n\nThe main hypothesis is that infants who used the pacifier from 1 month- to 6 month-old will have lower OSA severity (estimated by the obstructive apnea hypopnea index on polysomnography (PSG)).",[27,181],"Down Syndrome (Trisomy 21)",[183,184,185,186,187,188],"Sleep apnea","Down syndrome","Oro-myo-functional development","Sleep","Non-nutritive sucking","Pacifier","2026-06-16",{"date":156,"type":35},{"date":34,"type":21},{"date":193,"type":21},"2029-01-01",{"name":195,"class":42},"Hospices Civils de Lyon",{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":215,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100627110","start-cpap-therapy-in-obstructive-sleep-apnea-patients-after-atrial-fibrillation-ablation-100627110","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.","75 Years",{"count":206,"type":21},658,[24],"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.",[27,210,211,212,213,214],"Sleep Disorder (Disorder)","Atrial Fibrillation (AF)","Sleep Disordered Breathing (SDB)","Arrhythmia","Continuous Positive Airway Pressure",[27,214,216,217,218,219,220],"Atrial Fibrillation","Ablation of atrial fibrillation","Sleep Disordered Breathing","Clinical Trial","Catheter Ablation","2026-06-14",{"date":189,"type":35},{"date":224,"type":35},"2026-05-12",{"date":226,"type":21},"2029-01-31",{"name":228,"class":42},"Beijing Anzhen Hospital",27,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":236,"sex":16,"minAge":17,"maxAge":204,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100425016","atrial-fibrosis-in-obstructive-sleep-apnea-patients-a-pilot-study-100425016","NCT04814420","Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study","Inclusion Criteria:\n\nGroup A: 10 patients 18-75-year-old With mild OSA (5\\\u003CAHI\\\u003C15), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup B: 10 patients 18-75-year-old With moderate OSA (15\\\u003CAHI\\\u003C30), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup C: 10 patients 18-75-year-old With severe OSA (AHI\\>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5\\\u003CAHI\\\u003C15), confirmed by polysomnography. Previous AF diagnosis\n\n* In this group, patients with AF and OSA who already have done MRI might be included.\n\nGroup E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI\\>30), confirmed by polysomnography. Previous AF diagnosis\n\n\\*In this group, patients with AF and OSA who already have done MRI might be included.\n\nGroup F (Control): 10 Patients 18-75-year-old No previous OSA and\u002For AF Diagnosis on the medical chart\n\nExclusion Criteria:\n\n* History of chronic heart failure (LVEF \\\u003C 50%), AF, myocardial infarction, valvular disease.\n* Prior cardiac or chest surgery.\n* Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.\n* Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices\u002Fimplants contraindicated for MRI, glomerular filtration rate \\\u003C30 ml\u002Fmin, etc.).\n* Pregnancy.\n* Inability to give informed consent.",true,{"count":238,"type":21},60,[24],"The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).",[216,27],[243,244,245,246],"Ablation","Atrial Fibrosis","Delayed Enhancement Magnetic Resonance Imaging","Electrocardiogram","2026-06-11",{"date":249,"type":35},"2026-06-15",{"date":251,"type":35},"2021-07-12",{"date":253,"type":21},"2026-11",{"name":255,"class":42},"Tulane University",3,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":238},"100610292","phase-3-maridebart-cafraglutide-versus-placebo-in-adult-participants-with-obstructive-sleep-apnea-on-positive-airway-pressure-therapy-100610292","NCT07225686","Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living With Overweight or Obesity","MARITIME-OSA-1","Inclusion Criteria:\n\n* AHI ≥ 15 on polysomnography at day 1 before randomization.\n* BMI ≥ 27 kg\u002Fm\\^2 at screening.\n* History of at least 1 unsuccessful attempt at weight loss by diet and exercise.\n* On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the trial.\n\nExclusion Criteria:\n\n* Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.\n* Significant craniofacial abnormalities that may affect breathing at screening.\n* Diagnosis of Central Apnea with % of central apneas\u002Fhypopneas ≥ 50%, and\u002For diagnosis of Cheyne Stokes Respiration.\n* Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.\n* Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator.\n* Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.","99 Years",{"count":267,"type":21},250,[269],"PHASE3","This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.",[272,27],"Obesity",[274,275,276,272],"MariTide","Maridebart Cafraglutide","AMG 133",{"date":278,"type":35},"2026-06-12",{"date":280,"type":35},"2025-12-19",{"date":282,"type":21},"2028-09-13",{"name":284,"class":165},"Amgen",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":265,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":297,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":305},"100610375","phase-3-maridebart-cafraglutide-versus-placebo-in-adult-participants-with-obstructive-sleep-apnea-not-on-positive-airway-pressure-pap-therapy-100610375","NCT07226765","Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)","MARITIME-OSA-2","Inclusion Criteria:\n\n* Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization.\n* Body Mass Index (BMI) of 27 kg\u002Fm\\^2 or more at the time of screening.\n* History of at least one unsuccessful attempt at weight loss through diet and exercise.\n* Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling\u002Funable to use PAP, and do not plan to use PAP therapy during the study.\n\nExclusion Criteria:\n\n* Individuals who have had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.\n* Those with significant craniofacial abnormalities that may affect breathing at screening.\n* Participants diagnosed with Central Apnea with a percentage of central apneas\u002Fhypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.\n* Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.\n* Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.",{"count":267,"type":21},[269],"This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are not on PAP therapy and are living with overweight or obesity.",[27],[298,152,299,272,275,276,274],"Obstructive sleep apnea","Overweight",{"date":278,"type":35},{"date":302,"type":35},"2025-11-25",{"date":282,"type":21},{"name":284,"class":165},54,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":16,"minAge":312,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":325,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":43},"100376320","impact-of-positive-airway-pressure-therapy-on-clinical-outcomes-in-older-veterans-with-chronic-obstructive-pulmonary-disease-and-comorbid-obstructive-sleep-apnea-overlap-syndrome-100376320","NCT04179981","Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)","Inclusion Criteria:\n\n* OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (\\>10 pack-years) of smoking\n* Male or female gender\n* Age greater than or equal to 60 years\n* Stable treatment regimen for COPD\n\nExclusion Criteria:\n\n* Current or prior treatment with PAP or oral appliance\n* Central sleep apnea defined as central apnea index \\>5 per hour and comprising 50% of AHI\n* Known primary neuromuscular diseases\n* Disorders that may impact cognitive function including:\n\n  * neurodegenerative disorders\n  * traumatic brain injury\n* untreated PTSD and\u002For history of learning disability\n* Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results\n* Patient is actively suicidal due to depression, unstable mental health condition\n* Epworth sleepiness score \\>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months\n* Narcolepsy is the primary sleep disorder, with requirement of stimulant medications\n* Employed as a commercial driver or operating heavy machinery\n* On long-term oxygen therapy prior to start of study, more than 12 hr\u002Fday\n* Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia)\n* Consumption of \\>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits\n* Patients who cannot give informed consent\n* Patients receiving hospice care\n* Pregnant women due to unknown risks","60 Years",{"count":314,"type":21},668,[24],"Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.",[318,27,319,320,83,321,322,323,324],"Sleep Apnea Syndrome","COPD","Overlap Syndrome","Neurocognitive Function","Sleepiness","Elderly","Positive Airway Pressure",[326,327,328,329,330,331,332,333,334,335,336],"Apnea","Sleep Apnea Syndromes","Sleep Apnea, Obstructive","Nervous System Diseases","Respiration Disorders","Respiratory Tract Diseases","Signs and Symptoms, Respiratory","positive airway pressure","cognitive function","quality of life","sleepiness","2026-06-03",{"date":339,"type":35},"2026-06-05",{"date":341,"type":35},"2020-12-01",{"date":343,"type":21},"2027-12-31",{"name":345,"class":346},"VA Office of Research and Development","FED",{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":43},"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":267,"type":21},[269],"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.",[358,27],"Sleep Apnea",[360,361,362,363,364],"Continuous Positive Airway Pressure (CPAP)","sleep apnea","hypnotic","mechanism","arousability","2026-06-01",{"date":337,"type":35},{"date":368,"type":35},"2026-05-18",{"date":370,"type":21},"2030-06",{"name":372,"class":42},"Yale University",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":16,"minAge":380,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":397,"locationsCount":43},"100457508","phase-2-the-cardiovascular-consequences-of-sleep-apnea-plus-copd-overlap-syndrome-100457508","NCT05237505","The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)","CRESCENDO-SLP","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Persons aged 40-79.\n* For women, only postmenopausal women will be included\n* Diagnosed with untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events\u002Fhr and ≤80 events\u002Fhr) and\u002For diagnosed with COPD with FEV1\u002FFVC ratio \\\u003C0.7 and will be on stable medications as assessed by a board-certified pulmonologist.\n\nExclusion Criteria:\n\n* Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation\n* Presence of specific devices: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices, metallic foreign bodies, implantable neurostimulation systems, cochlear implants\u002Fear implant, drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps), metallic fragments such as bullets, shotgun pellets, and metal shrapnel , cerebral artery aneurysm clips, magnetic dental implants, and artificial limb.\n* Known allergic reactions to components of the study intervention: (if getting contrast, MRI contrast (gadolinium)).\n* Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).\n* Exhibit Cheyne-Stokes respiration or central sleep apnea (\\> 25 % of events central)\n* Take potentially confounding medications or hormones that affect breathing.\n* Subjects will be excluded if they are deemed medically unstable with active neurological, cardiac, liver, endocrine, and infectious diseases.\n* We will also exclude participants with pulmonary disease apart from COPD.\n* We will exclude participants with active cancer treatment.\n* We will exclude azotemia (estimated glomerular fraction rate \\\u003C 30ml\u002Fmin) as there is some concern about giving gadolinium to these patients (if getting contrast MRI).\n* people with exposures deemed to be problematic for the research e.g. any smoking in bedroom by participant or household member, major second-hand smoke, e-cigarettes, tetrahydrocannabinol, major drug or alcohol consumption (\\>3 oz\u002Fday) and other environmental pollution effects (indoor and outdoor).\n* Individuals who are already on continuous O2 for COPD or PAP treatment for OSA.\n* Patients with sustained desaturations below 89% during wake time will be excluded for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care.\n* Individuals with OSA (AHI range 15-80\u002Fhr) will be screened for pathological sleepiness and will be excluded if ESS \\>18\u002F24, history of motor vehicle accident or near miss accident, or high-risk occupation.\n* COPD individuals with arterial PCO2 higher than 52 mmHg will be excluded.\n* Individuals who are currently incarcerated.","40 Years","79 Years",{"count":383,"type":21},240,[54],"Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown. OSA has been associated with major neurocognitive and cardiovascular sequelae, the latter likely a function of autonomic nervous system abnormalities, oxidative stress, inflammation, and other pathways. Recent data suggest that individuals with OVS die preferentially of cardiovascular disease compared to OSA or COPD alone, although mechanisms are again unclear.\n\nThe combination of OSA and COPD may lead to profound hypoxemia. Individuals with COPD can develop pulmonary hypertension via disturbances in gas exchange and parenchymal injury leading to loss of pulmonary vasculature. OSA has been associated with mild to moderate pulmonary hypertension, but the situation may be worse if combined with parenchymal lung disease. The biological response to sustained hypoxemia has been carefully studied as has the topic of intermittent hypoxemia; however, to our knowledge, very little research has occurred regarding the combination of sustained plus intermittent hypoxia as seen in OVS. For example, we do not really know whether individuals with OVS develop coronary disease, right or left heart failure, dysrhythmias or some combination of abnormalities predisposing them to cardiovascular death. Thus, design of interventional studies is challenging as causal pathways are poorly understood despite our considerable preliminary data addressing these issues.\n\nThe purpose of this study is to examine vascular mechanisms in individuals with COPD\u002FOSA overlap syndrome (OVS) compared with matched individuals with obstructive sleep apnea (OSA) alone or chronic obstructive pulmonary disease (COPD) alone and to perform a phase II pilot mechanistic clinical trial in OVS to examine the effect size of nocturnal bi-level positive airway pressure (PAP) vs. nocturnal oxygen therapy in cardiovascular outcomes.",[27,387,320],"Chronic Obstructive Pulmonary Disease",[152,155,319,389,390,391,392],"chronic obstructive pulmonary disease","PAP therapy","oxygen","cardiovascular health",{"date":337,"type":35},{"date":395,"type":35},"2024-02-13",{"date":66,"type":21},{"name":398,"class":42},"University of California, San Diego",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":236,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":43},"100589883","phase-2-phototherapy-for-non-responders-to-oral-appliance-therapy-for-obstructive-sleep-apnea-100589883","NCT06960200","Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep Apnea","Inclusion Criteria:\n\n* diagnosed with OSA\n* incomplete treatment with OAT\u002FMAD\n\nExclusion Criteria:\n\n* not diagnosed with OSA\n* using CPAP",{"count":406,"type":21},528,[54],"Obstructive sleep apnea (OSA) is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. However, while the majority of OSA patients are able to tolerate the use of oral appliance therapy (OAT) for OSA, some patients are incomplete responders to OAT. These patients, despite having improvement, may still have a disease index above the diagnostic threshold for OSA.\n\nPhototherapy (laser therapy) has been used as a method to stiffen the soft palate and parts of the tongue to prevent their collapse. This is a type of cold laser therapy that does not cut\u002Fablate tissue (similar to healing laser therapies). This has been shown to help with both snoring and can also help with OSA, as soft palate and tongue collapse are common areas for where OSA occurs inside the airway. A recent pilot study has shown that phototherapy on its own may be able to treat selected patients with mild, moderate, or severe OSA. To our knowledge, there are no contraindications to combining phototherapy and dental sleep appliance therapy.",[27],"2026-05-29",{"date":365,"type":35},{"date":413,"type":35},"2024-01-05",{"date":415,"type":21},"2030-12",{"name":417,"class":42},"University of Alberta",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":236,"sex":16,"minAge":425,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":43},"100509301","osa-18-in-children-with-mild-obstructive-sleep-apnea-can-it-be-a-helpful-decision-making-tool-100509301","NCT05911646","OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?","OSA-18","Inclusion Criteria:\n\n* Parent\u002Fcaregiver of child with an initial diagnosis mild obstructive sleep apnea defined as polysomnography AHI score between 1 and 5\n* Parent\u002Fcaregiver of child between 3 and 12 years of age\n* Parent\u002Fcaregiver of child who has been diagnosed with tonsillar hypertrophy grade 2 or higher\n\nExclusion Criteria:\n\n* Parent\u002Fcaregiver of child diagnosed with a syndromic or known neurologic condition and\u002For multiple (more than two) medical cardiac or respiratory medical conditions\n* Parent\u002Fcaregiver of child who has previously underwent tonsillectomy","3 Years","12 Years",{"count":428,"type":21},130,[24],"The concept is a novel research idea that incorporates the potential impact of patient quality of life (QOL) on decision-making for treatment of mild obstructive sleep apnea (OSA). Our hypothesis is that in children with mild OSA there is significant conflict with parental decision-making; in the absence of significant sleep apnea, there is limited research regarding comparative efficacy of various treatment options. The impact of a QOL questionnaire can be a significant deciding factor and may help guide management decisions in such situations.",[432,27],"Apnea, Obstructive Sleep",[434],"Mild Obstructive Sleep Apnea","2026-05-26",{"date":437,"type":35},"2026-05-28",{"date":439,"type":35},"2021-06-02",{"date":441,"type":21},"2027-05-31",{"name":443,"class":42},"Connecticut Children's Medical Center",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":455,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":467},"100486774","enhancing-pap-adherence-among-spanish-speaking-hispanic-adults-with-osa-100486774","NCT05618444","Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA","Enhancing Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)","Inclusion Criteria:\n\n* Spanish-speaking and reading\n* Self-identified Hispanic\n* Adults ≥ 18 years-old\n* Males and females\n* Moderate-severe OSA defined as AHI ≥15 events\u002Fhour using a hypopnea criterion of a 4% oxygen desaturation (AHI4%)\n* Expected availability for the duration of the study (6 months from date of randomization)\n* Ownership of smartphone with unlimited text messaging capability\n* Referred to PAP treatment and able and willing to be treated with PAP\n\nExclusion Criteria:\n\n* Other sleep apnea or nocturnal respiratory insufficiency or failure diagnosis other than OSA established by polysomnogram (PSG) or home sleep apnea test (HSAT)\n* Requirement of supplemental oxygen or other non-invasive ventilation modality\n* Women referred to PAP because of new-onset OSA with pregnancy as PAP treatment may be time-limited (enrolled women who become pregnant during the trial and are already on PAP treatment will not be excluded)\n* Anticipated or scheduled bariatric surgery and\u002For referred to sleep evaluation by bariatric surgery",{"count":177,"type":21},[24],"This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanic adults, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA.",[27],[456,457,458,459],"positive airway pressure (PAP)","adherence","Hispanic","tele-management",{"date":437,"type":35},{"date":462,"type":21},"2026-09",{"date":464,"type":21},"2027-04",{"name":466,"class":42},"Geisinger Clinic",4,{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":16,"minAge":312,"maxAge":475,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":482,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":43},"100263017","neurocognitive-and-health-impact-of-sleep-apnea-in-elderly-veterans-with-comorbid-copd-100263017","NCT02703207","Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD","Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD","Inclusion Criteria:\n\n* OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index (AHI) 15\\* per hour by polysomnography\n* Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1\u002FFVC ratio \\\u003C70% and FEV1 \\>30% and \\\u003C80% of predicted based on PFT done within the past 1 year and a past significant history (10 pack-years) of smoking\n* Age 60 years\n* Male or female gender\n\nExclusion Criteria:\n\n* Mild COPD\n* Mild OSA\n* Overlap Syndrome with mild OSA plus mild COPD\n* Central sleep apnea defined as central apnea index \\>5 per hour\n* Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance\n* Current smokers\n* Pregnant women\n* Disorders of hypoventilation due to known neuromuscular or chest wall diseases\\*\\*\n* Patients with significant restrictive lung disease on pulmonary function testing\n* Recent admission for any acute illness within the prior 4 months\n* Current psychiatric illness requiring sedating medications\n* Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3\u002F4\n* For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score \\>10)\n* History of learning disability\n* Inability to sign consent\n* Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months\n* Patients with unstable heart disease, decompensated heart failure, ejection fraction\\\u003C45% or uncontrolled arrhythmias\n* Patients unable to use either a nasal or face mask (e.g., facial trauma)\n* Consumption of \\> 2 alcoholic beverages per day or past history of excessive alcohol use\n* Current use of illicit drugs\n* Patients who have problems with vision or dexterity and hence, cannot use CPAP\u002FNIPPV\n* Life expectancy is less than 6 months","89 Years",{"count":477,"type":21},108,[24],"Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.",[27,481],"OSA COPD Overlap Syndrome",[155,319,483,335,484,336,485],"Overlap syndrome","neurocognitive function","elderly","2026-05-21",{"date":435,"type":35},{"date":489,"type":35},"2016-08-17",{"date":491,"type":21},"2027-03-31",{"name":345,"class":346},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":501,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":43},"100640306","assessment-of-heart-rate-variability-for-predicting-obstructive-sleep-apnea-in-patients-with-hypertension-100640306","NCT07603583","Assessment of Heart Rate Variability for Predicting Obstructive Sleep Apnea in Patients With Hypertension","The Exploration of the Relationship Between Hypertension and Sleep Apnea Through Heart Rate Variability, and the Subsequent Investigation of Non-pharmacological and Pharmacological Treatments","HRV-OSA-HTN","Inclusion Criteria:\n\n* Age 18 to 65 years\n* Diagnosed hypertension or resistant hypertension\n* STOP-Bang score ≥3 indicating high risk of obstructive sleep apnea\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Refusal to undergo HRV monitoring or polysomnography\n* Unstable medical condition that may interfere with study participation\n* Inability to comply with study procedures",{"count":128,"type":21},"This study aims to investigate the relationship between hypertension and obstructive sleep apnea (OSA) using heart rate variability (HRV) as a non-invasive biomarker of autonomic nervous system function.\n\nHypertensive patients at high risk for OSA will undergo 24-hour Holter electrocardiogram monitoring to assess HRV parameters, along with overnight polysomnography (PSG) to determine OSA severity. The study will analyze the association between HRV indices and the apnea-hypopnea index (AHI), and develop predictive models using machine learning techniques.\n\nIn addition, patients diagnosed with OSA will be followed after treatment, and changes in HRV and blood pressure will be evaluated to assess treatment effects and autonomic function recovery.\n\nThe results of this study may provide a cost-effective and clinically applicable approach for early detection, risk stratification, and management of OSA in patients with hypertension.",[27,504],"Hypertension",[506,88,507,508,509],"Heart Rate Variability","CPAP","Sleep Apnea Screening","Machine Learning",{"date":511,"type":35},"2026-05-22",{"date":513,"type":35},"2026-04-30",{"date":515,"type":21},"2026-12-31",{"name":517,"class":42},"Kaohsiung Armed Forces General Hospital",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":16,"minAge":425,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":43},"100462616","phase-2-dexmedetomidine-versus-propofol-sedation-for-drug-induced-sleep-endoscopy-in-pediatric-obstructive-sleep-apnea-100462616","NCT05303987","Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea","Trial of Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea","Inclusion Criteria:\n\n1. Diagnosed with Obstructive sleep apnea (OSA) by the following criteria: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 1.5, confirmed on nocturnal, laboratory-based polysomnography within the previous 12 months scored using American Academy of Sleep Medicine pediatric criteria in an accredited sleep lab.\n2. Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist.\n3. Clinical determination by the child's otolaryngologist surgeon that the child would benefit from sleep endoscopy prior to adenotonsillectomy due to one or more reported risk factors for residual sleep apnea after surgery, which may include:\n\n   1. Obese (\\>95th percentile of body mass index for age)\n   2. Severe preoperative OSA (AHI ≥10 events\u002Fhour)\n   3. Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity;\n   4. African American race\n   5. Age ≥7 years old\n4. Male or Female ages 3.00 - 11.99 years of age at the time of consent\n5. Parent\u002Fguardian ability to understand and willingness to sign a written informed consent..\n6. Parent\u002Fguardian must understand\u002Fread\u002Fspeak English or Spanish and be able and willing to complete questionnaires.\n\nExclusion Criteria:\n\n1. Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred \\>18 months prior to recruitment.\n2. Major medical diagnosis that may be exacerbated by the study treatment, pose undue risk to the patient, or that may impact interpretation of study results\n3. History of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane\n4. Allergy to eggs, egg products, soybeans or soybean products.\n5. Contraindication to receiving general anesthesia","11 Years",{"count":527,"type":21},90,[54],"This research study is designed to learn, first, whether two anesthetics have different effects on collapse seen within the upper airway during sleep endoscopy. A second purpose is to learn whether collapse at several levels of the upper airway is associated with obstructive sleep apnea that persists after adenotonsillectomy, the surgery that removes the tonsils and adenoids.",[27],[532,533,534],"Drug-Induced Sleep Endoscopy","Propofol","Dexmedetomidine","2026-05-11",{"date":537,"type":35},"2026-05-14",{"date":539,"type":35},"2022-10-05",{"date":541,"type":21},"2027-01-01",{"name":543,"class":42},"Erin Kirkham",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":236,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":551,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":559,"leadSponsor":561,"locationsCount":43},"100589880","phase-1-exploring-the-use-of-phototherapy-to-improve-cpap-compliance-100589880","NCT06960161","Exploring the Use of Phototherapy to Improve CPAP Compliance","Inclusion Criteria:\n\n* using CPAP\n* problems with CPAP tolerance\u002Fsnoring\n\nExclusion Criteria:\n\n* not using CPAP",{"count":20,"type":21},[552],"PHASE1","Photobiomodulation (PBM) is a type of light therapy like lasers and LEDs. PBM was previously known by different terms like \"low-level laser therapy\" (LLLT) or \"photobiostimulation.\" LLLT, despite its name, can also have effects beyond biomodulation, including thermal effects useful in medical imaging and therapy.\n\nPBM works by interacting with our biological systems, and its clinical benefits depend on factors like light wavelength, and energy output.\n\nPBM has various clinical applications, such as wound healing, pain management, and treatment in sports injuries. It's also used as an adjunct to surgery, reducing risks and improving outcomes in areas like wound healing and inflammation. In oral medicine, PBM is applied to conditions like oral aphthous ulcers and is well-recognized for its positive effects in treatment of oral inflammation for oncology patients.\n\nRecent studies indicate that PBM, when administered by trained professionals, can improve sleep quality and reduce snoring\u002FSDB in adults. There's potential for its use in treating obstructive sleep apnea (OSA), showing effectiveness similar to dental sleep appliances but with fewer side effects. This effect seems to be from stabilization of the upper airway. Combining PBM with other therapies, like dental sleep appliances, has shown promise in enhancing effectiveness.\n\nHowever, whether the effect of PBM in stabilizing the upper airway to reduce snoring\u002FSDB can be used in combination with continuous positive airway pressure (CPAP) to decrease CPAP pressures and improve patient compliance has not been explored.",[27],"2026-05-06",{"date":557,"type":35},"2026-05-08",{"date":413,"type":35},{"date":560,"type":21},"2030-12-31",{"name":417,"class":42},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":573,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":43},"100501040","phase-2-patient-centered-and-neurocognitive-outcomes-with-acetazolamide-for-sleep-apnea-100501040","NCT05804084","Patient-centered and Neurocognitive Outcomes With Acetazolamide for Sleep Apnea","PANACEA","Inclusion Criteria:\n\n* Age ≥18 years\n* Body mass index ≤ 35 kg\u002Fm2\n* Untreated moderate\u002Fsevere OSA (AHI ≥15\u002Fh)\n\nExclusion Criteria:\n\n* Substantial sleep hypoxemia (SpO2\\\u003C80% for \\>10% of the monitoring time during the home sleep test, or for \\>25% of the total sleep time during any of the in-laboratory studies)\n* Abnormally low blood counts\u002Felectrolytes or renal function at baseline\n* Use of OSA therapy during the past 1 month, or plans to urgently resume\u002F(re)start clinical OSA therapy within 3 months\n* Significant, uncontrolled cardiac, pulmonary, endocrine, renal, hepatic, neurocognitive, psychiatric, or urologic (e.g., kidney stones) disorder\n* Other major sleep disorder (e.g., narcolepsy)\n* Urgent need to initiate effective OSA therapy (i.e., Epworth sleepiness score \\>18, commercial driver, prior sleep-related car accident, or based on MD judgment)\n* Severe allergy to sulfa-drugs or taking another carbonic-anhydrase inhibitor (e.g., topiramate)\n* Pregnancy\u002Fbreastfeeding (current\u002Fplanned)\n* Prisoners\n* Illicit substance abuse or \\>2 standard drinks of alcohol\u002Fday\n* Medications that may affect OSA or ventilatory control (e.g., opiates, sedatives)\n* Thiazide\u002Floop diuretic (risk of hypokalemia)\n* Inability to give consent or follow procedures\n* Safety concern based on MD judgment",{"count":238,"type":21},[54],"Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure, memory problems and can severely affect quality of life. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated.\n\nAcetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Further, its low cost (66¢\u002Fday) and once-daily dosing may be attractive for OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations such as studying acetazolamide for only a few days and not capturing important outcomes. The goal of this study is to test if acetazolamide can improve sleep apnea, neurocognitive function and quality of life in adults with OSA, and to assess how it does that. Thus, the investigators will treat 60 OSA patients with acetazolamide or placebo for 4 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 4 week period the investigators will assess OSA severity, neurocognitive function and quality of life. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide.\n\nUltimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments",[27],[27,152,574,575],"Acetazolamide","Precision medicine",{"date":557,"type":35},{"date":578,"type":35},"2023-05-16",{"date":580,"type":21},"2026-10-31",{"name":398,"class":42},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":43},"100408801","prevalence-and-impact-of-obstructive-sleep-apnea-in-multiple-sclerosis-100408801","NCT04603196","Prevalence and Impact of Obstructive Sleep Apnea in Multiple Sclerosis","SOMNUS","Inclusion Criteria:\n\n* Written consent\n* Over age 18\n* Confirmed diagnosis of multiple sclerosis\n\nExclusion Criteria:\n\n* cannot provide informed consent",{"count":590,"type":21},800,"This study will evaluate the influence of sleep apnea on clinical and radiological features of MS. Sleep apnea is associated with hypoxemia during sleep, which is likely detrimental to MS. Clinical data (MRI, lab results, medical history, labs, and sleep studies) of MS patients will be collected and analyzed. This will be done to study correlations between MRI, clinical data, lab studies and sleep studies. There is specific interest in the type of sleep apnea associated with MS, and whether MRI or clinical metrics of MS severity correlate with presence or absence of sleep apnea.",[593,27],"Multiple Sclerosis",{"date":535,"type":35},{"date":596,"type":35},"2019-06-20",{"date":598,"type":21},"2030-06-20",{"name":600,"class":42},"Beth Israel Deaconess Medical Center",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":16,"minAge":380,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":620,"locationsCount":43},"100369616","increasing-the-use-of-an-anti-snoring-mouth-guard-mandibular-advancement-appliance-to-prevent-upper-airway-collapse-during-sleep-in-patients-with-obstructive-sleep-apnoea-100369616","NCT04092660","Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.","Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial","IPOSAT","Inclusion Criteria:\n\n* Adult (≥ 40 years old)\n* Confirmed diagnosis of OSA (AHI ≥ 5)\n* Referred for MAA therapy\n* Must be able to understand, read and write English; with the assistance of a translator\n\nExclusion Criteria:\n\n* Insufficient teeth for MAA fabrication\n* Poor dental and\u002For periodontal health\n* Symptomatic Temporomandibular Disorder (TMD)\n* Previously used an MAA\n* Patients with Epilepsy","90 Years",{"count":611,"type":21},56,[24],"Obstructive Sleep Apnoea (OSA) is a sleep-related breathing disorder that is characterized by the repeated collapse of the upper airway during sleep, resulting in sleep deprivation. Mandibular Advancement Appliances (MAA) or Oral Appliances (OA) is prescribed for the patients with OSA and they have been shown to be effective. However, they rely entirely on the patient's acceptance and use. The aim of this study is to assess whether interventions- additional support approaches, will help patients use their MAA more as compared to those who receive routine care.\n\nThe investigators also will try and identify factors that help us to understand why some patients choose to wear the MAA more than others. Adults (≥40 years) with a confirmed diagnosis of OSA (apnoea-hypopnoea index \\>5) and referred for MAA therapy will be included in this study. It is a multicentre study comprised of recruiting patients from secondary care. Patients will be provided with information in relation to the study and written informed consent obtained at their subsequent appointment for placement of MAA.\n\nPatients will be randomly assigned to Intervention Care (IC) and Standardised care (SC). Patients will also be provided with a sleep diary to subjectively record their hours of sleep and usage of MAA and an objective adherence record from the micro-sensor included in their MAA design. Data indicating adherence will be collected and evaluated, both subjectively at 3- (T2) and 6-months (T3) and objectively by downloading the data stored within a micro-sensor placed in the MAA device. At the end of the follow-up, the investigators also plan to undertake a qualitative one-to-one interview with patients compliant (users) and non-compliant (non-users) to identify their views of what helps and\u002For prevents their adherence.",[27],"2026-05-05",{"date":555,"type":35},{"date":618,"type":35},"2019-12-06",{"date":365,"type":21},{"name":621,"class":42},"Queen Mary University of London",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":381,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":635,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":643,"leadSponsor":645,"locationsCount":43},"100639471","phase-1-combination-upper-airway-electrical-and-pharmacological-stimulation-for-obstructive-sleep-apnea-100639471","NCT07577661","Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea","Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea: A Randomized-Controlled Trial.","Inclusion Criteria for Enrolment:\n\n* Ages 18 - 79 years\n* Diagnosed OSA\n* Implantation of a hypoglossal nerve stimulation device (HGNS, Inspire Medical) or scheduled for implantation (implantation required for randomization)\n* Willingness to withhold HGNS while testing therapies (up to 6 weeks with HGNS off \\[with\u002Fwithout pharmacotherapy\\] to assess benefits of HGNS therapy).\n\nExclusion Criteria:\n\n* Any uncontrolled medical condition\n* Current use of the medications under investigation.\n* Issues relating to short-term withdrawal of HGNS therapy\n\n  * Excluded: Occupational driving (truck drivers, fork-lift operation, taxi\u002Fuber drivers)\n  * Excluded: History of traffic accidents attributable to sleepiness or fatigue (\\\u003C2 years).\n* Use of SNRIs\u002FSSRIs or anticholinergic medications during the study.\n* Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.\n* Respiratory disorders other than sleep disordered breathing:\n\nchronic hypoventilation\u002Fhypoxemia (awake SaO2 \\\u003C 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.\n\n* Other sleep disorders: narcolepsy, parasomnias. Insomnia\n* Contraindications for atomoxetine and oxybutynin, including:\n\n  * hypersensitivity to atomoxetine or oxybutynin (angioedema or urticaria)\n  * pheochromocytoma\n  * use of monoamine oxidase inhibitors\n  * diagnosed benign prostatic hypertrophy, urinary retention\n  * suspected benign prostatic hypertrophy \u002F urinary retention based on a positive answer to either of the following questions:\n\n    1. \"During the last month, when urinating, have you had the sensation of not emptying your bladder completely more often than 1 out of 5 times?\"\n    2. \"During the last month, have you had a weak urinary stream more often than 1 out of 5 times?\n  * known untreated narrow angle glaucoma\n  * known bipolar disorder, mania, psychosis\n  * known history of major depressive disorder (age\\\u003C24).\n  * known history of attempted suicide or suicidal ideation within one year prior to screening\n  * known clinically significant constipation, gastric retention\n  * known pre-existing seizure disorders\n  * known clinically-significant kidney disorders (eGFR\\\u003C60 ml\u002Fmin\u002F1.73m2)\n  * known clinically-significant liver disorders\n  * known clinically-significant cardiovascular conditions\n  * moderate-to-severe hypertension (SBP\\>160 mmHg or DBP\\>100 mmHg measured at baseline; average of evening and morning measures)\n  * known cardiomyopathy (LVEF\\\u003C50%) or heart failure\n  * known advanced atherosclerosis\n  * recent cerebrovascular events (within 2 years)\n  * recent history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation (within 2 years)\n  * other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate\n  * myasthenia gravis\n  * pregnancy\u002Fbreast-feeding",{"count":630,"type":21},24,[552,54],"Obstructive sleep apnea (OSA) is a common condition in which the airway repeatedly collapses during sleep, leading to poor sleep quality and reduced oxygen levels. Hypoglossal nerve stimulation (HGNS) is an approved treatment that uses a small implanted device to stimulate the genioglossus muscle and keep the airway open. However, some patients continue to have OSA despite using HGNS. Atomoxetine and oxybutynin, \"AtoOxy\", is a promising pharmacologcal therapy under investigation that has been shown to activate pharyngeal muscles-in particular non-genioglossus muscles--but appears more efficacious in some patients than others.\n\nThis study will test whether the combination of AtoOxy and HGNS can further improve breathing during sleep compared to either monotherapy alone. Participants with OSA and an HGNS device will be randomized to receive, in random order: HGNS+AtoOxy, HGNS alone (plus placebo), AtoOxy alone (HGNS device off), and placebo (HGNS device off), in a cross-over trial.\n\nThe main goal is to determine whether the combined treatment reduces the number of breathing events during sleep; the primary outcome test will compare HGNS+AtoOxy versus HGNS alone. The effect of each intervention versus placebo will also be presented.\n\nThe study will also examine how individual patient characteristics influence response to treatment.",[27,634],"Sleep-disordered Breathing",[298,636,637,638,639],"Pharmacotherapy","Hypoglossal nerve stimulation","Oxybutynin","Atomoxetine","2026-05-04",{"date":535,"type":35},{"date":365,"type":21},{"date":644,"type":21},"2027-12-01",{"name":646,"class":42},"Brigham and Women's Hospital"]