[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,185,0,25,[9,47,78,101,138,171,190,210,236,264,299,320,339,364,392,416,438,469,490,518,539,560,580,603,622],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100561781","smart-pillows-for-enhancing-sleep-quality-100561781",false,"NCT06594627","Smart Pillows for Enhancing Sleep Quality","Smart Pillows for Enhancing Sleep Quality_Pilot Study","Inclusion Criteria:\n\n* Inclusion criteria for individuals with snoring issues or OSA\n\n  * Individuals 50 years of age or older.\n  * Individuals who experience snoring issues and\u002For OSA that may impact their perceived sleep quality or that of their sleep partner.\n  * Individuals who currently use and do not use snoring and\u002For OSA treatment (participants will not be asked or required to discontinue any current snoring and\u002For OSA treatments that they are prescribed or using.)\n  * Individuals who have a smartphone or a smart mobile device (Apple iOS 15 and higher or Android 10 or higher).\n  * Individuals with and without a sleep partner.\n  * Individuals who do not have a pacemaker.\n  * Individuals who do not have intracranial electrodes.\n  * Individuals who do not have neck pain related to the cervical spine problems, including disc, muscle, and neurological issues.\n\nInclusion criteria for sleep partners\n\n* Individuals aged 18 years and older.\n* Individuals who share the same sleeping space with their sleep partner (who has snoring issues and\u002For OSA) more than four times a week.\n* Individuals whose sleep partner (who has snoring issues and\u002For OSA) agrees to participate in this study.\n\nExclusion Criteria:\n\n* Any participant who is not able to consent or complete study interventions independently, as determined by the investigator.","ALL","50 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to examine the impact of smart pillows on the sleep quality of individuals who experience a snoring issue and\u002For obstructive sleep apnea (OSA), as well as their sleep partners. Furthermore, this study will explore whether enhancements in sleep quality positively influence depressive symptoms, physical activity, heart rate, blood oxygen levels, and cognitive functions.",[27,28],"Snoring","Obstructive Sleep Apnea",[30,31,32,33],"assistive device","sleep quality","snoring","obstructive sleep apnea","RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":38},"2024-11-18",{"date":42,"type":21},"2027-07-11",{"name":44,"class":45},"Indiana University","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":46},"100388301","enhancing-outcomes-in-cognitive-impairment-through-use-of-home-sleep-apnea-testing-100388301","NCT04335994","ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing","ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)","ENCHANT","Inclusion Criteria:\n\n* Evidence of cognitive impairment by any one of: (i) Montreal Cognitive Assessment (MoCA) score of 13-28, or (ii) Mini Mental State Examination (MMSE) score of 18-30, or (iii) Toronto Cognitive Assessment (TorCA) score ≤281.\n* A diagnosis of: (i) Single-domain amnestic or multiple cognitive domain (with one feature being amnestic) Mild Cognitive Impairment due to Alzheimer's disease (AD); or (ii) Probable AD dementia; or (iii) Possible AD dementia due to limited concomitant cerebrovascular disease; or (iv) Probable Vascular dementia or Vascular Mild Cognitive Impairment, as per the 2011 American Heart Association Scientific Statement; or (v) Patients with a suspected neurodegenerative condition known to be associated with non-OSA sleep disorders (e.g. Parkinson's disease-related dementia and dementia with Lewy Bodies); and\u002For (vi) Mixed disease\n* Have the competency to provide informed consent, or the availability of a substitute decision maker\u002Fcaregiver who can provide consent (if needed).\n* The availability of a caregiver to assist in the completion of HSAT or iPSG, if needed.\n\nExclusion Criteria:\n\n* Prior diagnosis of OSA within the last 2 years\n* Patients already using CPAP or a dental appliance for previously diagnosed OSA.\n* A known contraindication for the use of the HSAT that will be used in this study: (a) Moderate to severe pulmonary disease or congestive heart failure that could compromise the validity of the HSAT results (in users of the ApneaLink); (b) Permanent pacemaker or history of sustained non-sinus cardiac arrhythmia (in users of the WatchPAT).\n* Any medical device that would interfere with the placement of the HSAT\n* Significant physical impairment or language barrier that would restrict the ability to use the HSAT or complete the study assessments.",{"count":56,"type":21},200,[24],"Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI\u002FAD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI\u002FAD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI\u002FAD. Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.",[28,60,61,62,63,64,65],"Alzheimer Disease","Vascular Dementia","Mild Cognitive Impairment","Parkinsons Disease With Dementia","Dementia With Lewy Bodies","Mixed Dementia",[28,67,68,69],"Cognitive Impairment","Home Sleep Apnea Test","Screening","2026-08-19",{"date":35,"type":38},{"date":73,"type":38},"2019-09-23",{"date":75,"type":21},"2027-06",{"name":77,"class":45},"Sunnybrook Health Sciences Centre",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100630277","exploration-of-current-and-new-technologies-for-accuracy-of-diagnosing-osa-100630277","NCT07485582","Exploration of Current and New Technologies for Accuracy of Diagnosing OSA","Inclusion Criteria:\n\n* Participant is 18 years of age or older\n* Participant is willing to provide informed consent\n* Participant is willing to participate in all study related procedures\n\nExclusion Criteria:\n\n* Unable to cease PAP therapy during PSG (if currently using)\n* Requires use of oxygen therapy during sleep\n* Diagnosis of untreated clinically relevant sleep disorder (other than SDB, e.g. severe insomnia)\n* Who are or may be pregnant\n* Participants are unsuitable to participate in the study in the opinion of the investigator\n* Participant has a permanent pacemaker, sustained non-sinus cardiac arrhythmias, and\u002For takes alpha blocker or short acting nitrate medication.\n* Shift workers who worked an overnight shift in the past 3 days\n* Participant who are contraindicated to use the NightOwl sensor","18 Years",{"count":86,"type":21},90,"OBSERVATIONAL","Resmed is the manufacturer of medical devices which screen, diagnose, treat and monitor people with sleeping and respiratory disorders, such as obstructive sleep apnea (OSA).\n\nFrom time to time, for regulatory, quality, and marketing purposes, there may be a need to test the various products performance against PSG (gold standard technology), and other products.\n\nThe purpose of this study is:\n\n1. Products performance against PSG\n2. comparison against other products, and\n3. Assessments of potential new technologies",[28],"NOT_YET_RECRUITING","2026-08-17",{"date":70,"type":38},{"date":94,"type":21},"2026-09",{"date":96,"type":21},"2026-10",{"name":98,"class":99},"ResMed","INDUSTRY",5,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":119,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":46},"100479797","self-supporting-nasopharyngeal-airway-ssnpa-treating-upper-airway-obstruction-in-hypotonia-100479797","NCT05527652","Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia","Inclusion Criteria:\n\n* Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index \\[AHI\\]\\>10 or AHI\\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \\[SpO2\\] nadir \\\u003C=75%).\n* All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive\u002Finattentive behaviors)\n* Post adenotonsillectomy or those with contraindications to tonsillectomy.\n* Tonsil size 2+ or smaller.\n* Parent\u002Fcaregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.\n\nExclusion Criteria:\n\n* AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\\\u003C5 with hypoxemia.\n* Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable\n* Active Coronavirus (COVID) 19 infections\n* End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \\>60 mmHg for \\>10% of sleep time on PSG\n* Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit\u002FHyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.\n* Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)\n* Moderate\u002Fsevere tracheobronchomalacia\n* Need for anticoagulative therapy\n* Bleeding disorder\n* Restrictive thoracic disorders","3 Years","21 Years",{"count":110,"type":21},40,[24],"The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).",[28,114,115,116,117,118],"Hypertonia, Muscle","Nasal Airway Obstruction","Tolerance","Trisomy 21","Down Syndrome",[120,121,114,122,123,124,125,126,127,128,129,130],"Sleep Apnea Syndromes","Sleep Apnea, Obstructive","Apnea","Respiration Disorders","Respiratory Tract Diseases","Sleep Disorders, Intrinsic","Dyssomnias","Sleep Wake Disorders","Nervous System Diseases","Neuromuscular Manifestations","Neurologic Manifestations",{"date":70,"type":38},{"date":133,"type":38},"2022-11-16",{"date":135,"type":21},"2027-08",{"name":137,"class":45},"University of Michigan",{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"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 or major ear, nose or throat surgery for OSA.\n* Those with significant craniofacial abnormalities that may affect breathing at screening.\n* Participants diagnosed with Central or Mixed Sleep Apnea with proportion of mixed or central apneas\u002Fhypopneas ≥ 50%, and\u002For diagnosis of Cheyne Stokes Respiration.\n* Active device treatment of OSA or other treatments, that in the opinion of the investigator, may interfere with study outcomes.\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.","99 Years",{"count":148,"type":21},250,[150],"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 not on PAP therapy and are living with overweight or obesity.",[28],[154,155,156,157,158,159,160],"Obstructive sleep apnea","OSA","Overweight","Obesity","Maridebart Cafraglutide","AMG 133","MariTide","2026-08-13",{"date":163,"type":38},"2026-08-14",{"date":165,"type":38},"2025-11-25",{"date":167,"type":21},"2028-09-13",{"name":169,"class":99},"Amgen",57,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":187,"locationsCount":189},"100545377","app-based-optimization-of-long-term-cpap-adherence-and-quality-of-life-100545377","NCT06381115","App-Based Optimization of Long-Term CPAP Adherence and Quality of Life","An App-Based, Precision Medicine Approach to Optimize Long-Term CPAP Adherence and Quality of Life","Inclusion Criteria:\n\n* In both trials of Aim 2, twenty adults (≥18 years) per trial will be recruited who are newly diagnosed with OSA and speak English.\n* In both trials, we will purposely recruit samples balanced by biological sex and OSA severity (apnea hypopnea index: 5-14 vs. ≥ 15).\n* Inclusion Criteria are the same for both Aim 2 trials; Adult patients from MCCSM sites who:\n\n  * Are diagnosed with OSA based on clinical diagnostic testing via laboratory or home-based sleep study;\n  * Own and have the functional and cognitive ability to use an Apple (iOS9 or higher) or Android (4.2 or higher) smartphone with minimal to no assistance;\n  * Are prescribed continuous or auto-titrated CPAP;\n  * Agree to using a smartphone application and wearable wrist sensor; and\n  * Speak and read English.\n\nExclusion Criteria:\n\n* Unwilling to complete study measures and engage with SleepWell24;\n* Refuse to not use the Fitbit application during the study trial;\n* Have any conditions that would impede full participation (e.g., communication or cognitive impairments that limit ability to read and\u002For follow directions, other acute or severe health, cognitive, or psychological conditions);\n* Currently participating in other lifestyle programs (e.g. active, formal weight loss program or research study; smoking cessation program, etc.);\n* Decide to use a different PAP device than ResMed Airsense 10;\n* Prescribed high-dose benzodiazepines (equivalent to \\> 1 mg lorazapam\u002Fnight);\n* Daily opioid medication use at night;'\n* Unwilling to discontinue use of any current wearable sensor for the duration of the trial;\n* Previous documented history of treatment\u002Freferral for claustrophobia;\n* Previous CPAP use;\n* Currently engaging in shiftwork defined as night shift or rotating day and night shifts; and\n* Currently pregnant, trying to conceive, or breastfeeding.",{"count":110,"type":21},[24],"The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence.",[28],"2026-08-12",{"date":163,"type":38},{"date":185,"type":38},"2025-06-01",{"date":96,"type":21},{"name":188,"class":45},"Mayo Clinic",2,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":209,"locationsCount":46},"100636843","phase-2-a-study-of-synthetic-thc-and-sleep-100636843","NCT07570953","A Study Of Synthetic THC And Sleep","Effects Of Nocturnal Dronabinol Use On Obstructive Sleep Apnea Treatment And Physiological Outcomes","Inclusion Criteria\n\n* 21 - 70 years of age\n* Biological male or female\n* AHI between 15 - 50 events\u002Fhour\n* Current or new OSA diagnosis\n* Established or new (within 1 month) CPAP therapy\n\nExclusion Criteria\n\n* BMI \\> 35 kg\u002Fm2\n* Diagnosed psychiatric disorders\n* Hypotension\n* History of seizures\n* History of substance abuse or recreational drug use or positive urine drug screen\n* History of uncontrolled disease including:\n\n  * Cardiovascular\n  * Pulmonary\n  * Gastrointestinal\n  * Pancreatic\n  * Hepatic\n  * Renal\n  * Hematological\n  * Endocrine (including Type I Diabetes)\n  * Neurological\n  * Urological\n* Pregnant or breastfeeding\n* Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs\n* Prescribed CYP2C9 and\u002For CYP3A4 inhibitors\n* Severe OSA that in the investigator's judgment should only begin CPAP treatment\n* Prior upper airway surgery for snoring or OSA as an adult\n* Significant defect in nasal patency due to anatomical abnormality or uncontrolled rhinitis\n* Bariatric surgery within 2 years\n* Medically managed weight-loss program within 6 months\n* Noninvasive treatment for OSA within 1 month (self-report)\n* History of shift work or rotating shifts within 1 month","70 Years",{"count":199,"type":21},72,[201,150],"PHASE2","The purpose of this study is to determine if oral dronabinol prior to sleep can improve CPAP adherence and sleep quality in humans. We also seek to determine if combination therapy of CPAP and pre-sleep dronabinol is associated with improved BP regulation. We will also explore BP regulatory mechanisms and whether these are impacted differently between traditional CPAP therapy and combination CPAP\u002Fdronabinol.",[28],"2026-08-11",{"date":161,"type":38},{"date":94,"type":21},{"date":208,"type":21},"2028-04",{"name":188,"class":45},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":155,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":220,"conditions":221,"keywords":226,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":232,"leadSponsor":234,"locationsCount":46},"100651086","oliceridine-versus-sufentanil-analgesia-for-postoperative-patients-with-obstructive-sleep-apnea-100651086","NCT07753785","Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea","Effects of Oliceridine Versus Sufentanil Analgesia on Incidence of Postoperative Respiratory Depression in Patients at High-Risk of Obstructive Sleep Apnea: A Prospective Cohort Study","Inclusion Criteria:\n\n* Aged 18 to 90 years.\n* Diagnosed with obstructive sleep apnea according to polysomnography, or suspected to be at high risk of moderate-to-severe OSA according to the STOP-Bang questionnaire: (1) STOP-Bang score ≥ 5; (2) STOP-Bang score ≥ 3 with serum bicarbonate \\[HCO₃-\\] ≥ 28 mmol\u002FL; (3) STOP score ≥ 2 and male sex; (4) STOP score ≥ 2 and body mass index (BMI) \\> 35 kg\u002Fm²; or (5) STOP score ≥ 2 and neck circumference \\> 40 cm.\n* Scheduled to undergo elective non-cardiac surgery under general anesthesia.\n* Required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Scheduled to undergo pulmonary\u002Fthoracic surgery in the current admission;\n* Planning to receive use of epidural analgesia.\n* Preplanned postoperative admission to the intensive care unit (ICU) or requirement for mechanical ventilation.","90 Years",{"count":219,"type":21},851,"Opioids are frequently used for postoperative analgesia but may induce side effects. Opioid-induced respiratory depression is the most dangerous side effect of opioids. Patients with obstructive sleep apnea (OSA) are at higher risk for opioid-induced respiratory depression. Oliceridine is a novel biased μ-opioid receptor agonist that selectively engages the G-protein pathway while reducing β-arrestin recruitment and thus may lower the risk of respiratory depression. The goal of this observational study is to compare the effects of oliceridine versus sufentanil analgesia on the incidence of postoperative respiratory depression in patients with known or suspected OSA in the postoperative period following elective surgery.",[28,222,223,224,225],"Postoperative Analgesia","Oliceridine","Sufentanil","Respiratory Depression",[154,227,223,224,228],"Postoperative analgesia","Respiratory depression","2026-08-07",{"date":204,"type":38},{"date":94,"type":21},{"date":233,"type":21},"2029-12",{"name":235,"class":45},"Peking University First Hospital",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":46},"100552812","phase-1-dronabinol-treatment-of-osa-100552812","NCT06477952","DRonabinol Treatment of OSA","Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial","DROSA","Inclusion Criteria:\n\n1\\. AHI 15-50 per hour on pre-treatment polysomnography\n\nExclusion Criteria:\n\n1. Positive Airway Pressure (PAP) treatment of OSA: use \\> 4 hours per day for 30% of days within 3 months of enrollment. PAP use will be determined from device download data\n2. Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use \\> 4 hours per day for 30% of days within 3 months of enrollment. HNS use will be determined by device download and oral appliance use by self-report\n3. History of upper airway surgery for OSA (except adenotonsillectomy)\n4. Central or mixed apneas \\>25% of respiratory events on diagnostic polysomnography\n5. Arterial oxygen saturation \\\u003C 75% for \\> 5% sleep time on pretreatment polysomnography\n6. Body mass index \\> 45 kg\u002Fm2\n7. If post-bariatric surgery, weight must be stable ±5% (per electronic medical records) for at least 6 months before the first dose of the study drug\n8. Active enrollment in a weight loss program\n9. Shiftwork within 3 months of enrollment\n10. High-risk occupation: commercial driver and pilot\n11. Motor vehicle accident or near-miss incident within 1 year of enrollment\n12. Current drug or habitual alcohol use or positive urine drug screen\n13. Comorbid medical and psychiatric disorders:\n\n    1. Primary sleep disorders: e.g., narcolepsy, restless legs syndrome\n    2. Uncontrolled mood disorder or a diagnosis of schizophrenia\n    3. Initiation of new antidepressant or antipsychotic medication within 3 months\n    4. Identified as high-risk for suicide in electronic health records\n    5. Uncontrolled medical disorders (coronary heart disease, arrhythmia, congestive heart failure, chronic obstructive pulmonary disease, chronic hypoxemic or hypercapnic respiratory failure, stroke within 6 months of enrollment, chronic liver or kidney disease, autoimmune disorders)\n14. Use of sedative-hypnotic medications within 30 days of enrollment\n15. Complete blood count or liver function test values more than 1.5 times the upper limit of normal\n16. Pregnancy\n17. Allergy to cannabinoids or sesame oil\n18. Average weekly alcohol consumption of more than 10 servings\n19. Participation in other investigational protocols within 30 days of enrollment","65 Years",{"count":246,"type":21},120,[248,201],"PHASE1","This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks. Sleep studies will be conducted before and after treatment to measure OSA severity.",[28],[155,252,253,254],"sleep apnea","pharmacological treatment","Drug treatment","2026-08-06",{"date":204,"type":38},{"date":258,"type":38},"2025-08-25",{"date":260,"type":21},"2026-12-31",{"name":262,"class":263},"VA Office of Research and Development","FED",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":272,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100515198","the-effects-of-successful-osa-treatment-on-memory-and-ad-biomarkers-in-older-adults-study-100515198","NCT05988385","The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study","The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults (ESSENTIAL) Study","ESSENTIAL","Inclusion Criteria:\n\n* Cognitively normal (TiCS ≥29)\n* Age 55-85 years\n* Moderate - severe OSA defined as AHI4 ≥20 events\u002Fhour or AHI3A\\>40\u002Fhr using a hypopnea criterion of a 4% oxygen desaturation (AHI4) or 3% oxygen desaturation and\u002For EEG arousal (AHI3A), or equivalent based on in-home testing - Testing must have been completed in past 12 months or confirmed by repeat test\n* Not currently on therapy for OSA and has not received treatment for OSA for at least 6months\n* Able and willing to be treated for OSA (Treatment group)\n* Fluency in English or Spanish\n\nExclusion Criteria:\n\n* Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - an answer of severe or very severe in the screening form\n* Documented diagnosis of circadian rhythm disorder\n* Any current use of supplemental oxygen\n* Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria\n* Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo\n* Anticipated scheduled bariatric surgery within the next 3 months\n* Chronic regular (\\> 2 nights per week) of cannabis for sleep\n* Chronic regular use (\\> 2 nights per week) of sedatives\u002Fhypnotics for sleep\n* Diagnosis of uncontrolled psychiatric disease in the last six months , and\u002For history of schizophrenia or bipolar disorder. Controlled conditions will include major depressive disorder, panic disorder, generalized anxiety disorder, OCD, substance use disorders, and alcohol abuse\u002Fdependence. Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) are allowed if cognition is within normal limits.\n* Taking methylphenidate for ADHD. Unless on stable dose which will be reviewed by the PI to determine.\n* Taking GLP-1 agonist semaglutide (Ozempic, Wegovy, Rybelsus), or tirzepatide (Mounjaro, Zepbound), or similar for weightloss, and planning to lose an additional 20lbs or more at the time of enrollment. PI Discretion for determination of why they are taking the drug based on conversation with subject and medical chart, will be documented in form of Note-to-file in the subject's records\n* Presence of other comorbid condition that would lead to inability to complete the study protocol (including follow-up for 2 years), or that would affect cognition (e.g. clinically relevant endocrine or hematological conditions).\n* Does not have a regular sleeping environment (i.e., sleeps in a different setting \\> 2 nights per week).\n* Currently pregnant or planning to become pregnant.\n* Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, a loss of consciousness \\> 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with MCI or Alzheimer's disease based on neuropsychological testing will be excluded. Delirium in the last 12 months.\n* Near-miss or prior automobile accident \"due to sleepiness\" within the past 12 months.\n* Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots).\n* Any use of neuroleptics, benzodiazepines, barbiturates, opiates or anti-amyloid therapies.\n* Use of other cognitive enhancing drugs will also be excluded if initiated in the last 3 months, or not on stable dose.\n* Consumption of \\>14 alcohol drinks per week, unless alcohol consumption can be reduced if initiated in the last 3 months.","55 Years","85 Years",{"count":56,"type":21},[24],"The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an \"effective\" AHI4%\\\u003C 10\u002Fhour and AHI3A\\\u003C20\u002Fhour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.",[28,278],"Cognitive Decline",[28,155,280,60,281,282,283,284,285,286,287,288,289],"Cognitive decline","AD","AD biomarkers","Positive Airway Pressure","PAP","CPAP","Oral appliance therapy","OAT","Positional therapy","Sleep-dependent memory","2026-08-04",{"date":255,"type":38},{"date":293,"type":38},"2024-08-29",{"date":295,"type":21},"2028-05-31",{"name":297,"class":45},"California Pacific Medical Center Research Institute",4,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":4},"100633733","kpap-vs-epr-for-efficacy-100633733","NCT07530523","KPAP vs EPR for Efficacy","A Randomized Crossover Study of Continuous Positive Airway Pressure (CPAP) Treatment Efficacy: Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)","Inclusion Criteria:\n\n* BMI above 18 kg\u002Fm2, inclusive\n* Recent formal diagnosis of OSA meeting all the following criteria: AHI \\> 10, Central apneas \\\u003C 25% of events, PLM arousal index \\\u003C 15, no prior\u002Fconcomitant OSA therapy\n* Subject is fluent in English and subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.\n* Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the study-related procedures.\n\nExclusion Criteria:\n\n* A female of child-bearing potential that is pregnant or intends to become pregnant.\n* Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).\n* Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.\n* The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc.).\n* The presence of a psychiatric disorder, including attempted suicide within 1 year prior to screening, or current suicidal ideation.\n* A serious illness or infection in the past 30 days.\n* Excessive alcohol consumption (\\>21 drinks\u002Fweek).\n* The use of any illegal drug(s).\n* Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.\n* Chronic nocturnal oxygen therapy.\n* Active hypoglossal nerve stimulation implant.","20 Years","80 Years",{"count":20,"type":21},[24],"The KPAP EPR is a randomized, crossover study in which treatment efficacy will be compared between SleepRes CPAP + KPAP and ResMed CPAP + EPR. Participants will be chosen from those with a recent OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) and with no previous use of OS therapy (PAP-naïve).\n\nUpon signing an informed consent, participants will be scheduled to come to the sleep laboratory for a manual titration on CPAP. Once the therapeutic pressure is determined, participants will be randomized to start either CPAP + KPAP (delivered by a SleepRes device) or CPAP + EPR (delivered by a ResMed device). Participants will be blinded to the sequence order. They will then be invited to the laboratory for two overnight sleep studies, one on each treatment device, in the order determined by the randomization, with a minimum washout of 1 week and a maximum of 3 weeks. Both studies will use the therapeutic pressure determined during manual titration. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. The next morning of each sleep study, participants will be administered visual analog scale (VAS) questionnaires to examine subjective sleep quality (1=best sleep quality; 10=worst sleep quality) and, after all studies are completed a device subjective preference (1=CPAP+KPAP was extremely better than CPAP+EPR; 10=the opposite).\n\nThe study will be single blinded with both the participants (the device will be concealed in the laboratory so that participants will not be able to understand what treatment they are on) and the registered technician scoring the polysomnographies blinded to treatment allocation.",[28],"2026-08-03",{"date":290,"type":38},{"date":315,"type":21},"2027-03-01",{"date":317,"type":21},"2027-12-31",{"name":319,"class":99},"SleepRes Inc.",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":146,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":337,"locationsCount":338},"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 or major ear, nose, or throat surgery for OSA.\n* Significant craniofacial abnormalities that may affect breathing at screening.\n* Diagnosis of Central or Mixed Sleep Apnea with proportion of mixed or central apneas\u002Fhypopneas ≥ 50%, and\u002For diagnosis of Cheyne Stokes Respiration.\n* Active device treatment of OSA other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes.\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.",{"count":148,"type":21},[150],"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.",[157,28],[160,158,159,157],{"date":290,"type":38},{"date":335,"type":38},"2025-12-19",{"date":167,"type":21},{"name":169,"class":99},61,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":363},"100530666","micrornas-as-biomarkers-for-obstructive-sleep-apnea-100530666","NCT06189755","MicroRNAs as Biomarkers for Obstructive Sleep Apnea","MIR-OSA","Inclusion Criteria for Cases:\n\n* age 18-75 years\n* moderate-severe OSA (defined as AHI ≥15 events\u002Fhour)\n* willing to accept PAP therapy\n\nInclusion Criteria for Controls:\n\n* age 18-75 years\n* no OSA (defined as AHI \\\u003C5 events\u002Fhour)\n\nExclusion Criteria for Cases:\n\n* current use of PAP or other OSA treatments\n* home oxygen therapy\n* recent changes (within 3 months) to BP medications among those who are on these medications\n* presence of Cheyne-Stokes Respiration (CSR) in sleep study\n* predominantly central sleep apnea (AHI≥15 events\u002Fhour, with \\>50% central events)\n* pregnancy\n* clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant\n* organ transplantation\n* self-reported sleep duration less than 5 hours per night on weeknights (work nights)\n* current night shift work\n\nExclusion Criteria for Controls:\n\n* home oxygen therapy\n* pregnancy\n* clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant\n* organ transplantation\n* self-reported sleep duration less than 5 hours per night on weeknights (work nights)\n* current night shift work","75 Years",{"count":348,"type":21},500,"Although obstructive sleep apnea (OSA) is a common disorder, there are no blood biomarkers for identification and management of these patients. This project will study microRNAs in order to develop and validate blood biomarkers that are specific to OSA, useful for identification of cases with OSA, reflective of efficacy of therapy, and able to predict blood pressure response to treatment of OSA.",[28],[352,353,354],"Sleep Apnea","Biomarkers","Blood pressure","2026-07-30",{"date":312,"type":38},{"date":358,"type":38},"2024-04-01",{"date":360,"type":21},"2028-04-30",{"name":362,"class":45},"University of Pennsylvania",3,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":372,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":376,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":46},"100613932","tongue-muscular-assessment-in-children-with-sleep-disordered-breathing-100613932","NCT07273019","Tongue Muscular Assessment in Children With Sleep Disordered Breathing","Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea","TMAC-C","Inclusion Criteria:\n\n* With suspected sleep-disordered breathing\n* Referred for polysomnography\n* Affiliated to a social security scheme\n* With informed consent from both legal representatives\n\nExclusion Criteria:\n\n* Insufficient comprehension of French language\n* Regarding patients with suspected OSA type I or II:\n\n  * Neurological, cardiac, or unstable respiratory conditions other than sleep disorders and their repercussions\n  * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)\n  * Malformation of the skull, the upper airway or the oral cavity\n* Regarding patients with suspected OSA type III:\n\n  * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)\n  * Intellectual deficit impeding the understanding of instructions","4 Years","17 Years",{"count":375,"type":21},78,[24],"Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing.\n\nThe primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.",[28],[380,381,382,383],"Tongue","Motor functions","Sleep","Sleep apnea","2026-07-29",{"date":355,"type":38},{"date":387,"type":38},"2026-03-26",{"date":389,"type":21},"2028-03-26",{"name":391,"class":45},"Hospices Civils de Lyon",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":400,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":46},"100648678","combination-tonsillectomy-and-hypoglossal-nerve-stimulation-for-osa-patients-with-lateral-pharyngeal-collapse-100648678","NCT07724938","Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse","HGNS+T","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) ≥ 15 events\u002Fhour\n* Complete oropharyngeal lateral wall (OPLW) collapse identified on DISE\n* Candidate for HGNS implantation based on standard clinical criteria\n* Presence of small (1-2+) tonsils and eligibility for tonsillectomy\n* Untreated OSA at the time of enrollment\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Absence of tonsils\n* Presence of large tonsils (3-4+; not eligible for HGNS)\n* Predominant central or mixed sleep apnea (\\>25% central or mixed events)\n* Any unstable or serious medical condition that, in the opinion of the investigator, would increase risk or interfere with study participation\n* Ineligibility for HGNS implantation based on standard clinical or surgical criteria\n* Inability to comply with study procedures or follow-up assessments",{"count":199,"type":21},[24],"The goal of this clinical trial is to learn whether removing the tonsils at the time of hypoglossal nerve stimulation improves treatment of obstructive sleep apnea in adults whose airway collapses from the side of the upper airway during sleep. The main questions it aims to answer are:\n\n1. Does hypoglossal nerve stimulation combined with tonsillectomy reduce the severity of obstructive sleep apnea more than hypoglossal nerve stimulation alone?\n2. Does tonsillectomy improve how effectively hypoglossal nerve stimulation opens and stabilizes the upper airway?\n\nResearchers will compare participants who receive hypoglossal nerve stimulation with tonsillectomy to participants who receive hypoglossal nerve stimulation alone.\n\nParticipants will:\n\n* Complete sleep studies, questionnaires, and other assessments before and after treatment\n* Be randomly assigned to receive hypoglossal nerve stimulation either with or without tonsillectomy\n* Return for follow-up visits and sleep testing to evaluate treatment effectiveness\n* In a subset of participants, complete additional overnight testing to measure how treatment changes upper-airway collapsibility",[28,403],"Sleep Disordered Breathing",[154,405,406],"Hypoglossal nerve stimulation","Tonsillectomy","2026-07-23",{"date":409,"type":38},"2026-07-24",{"date":411,"type":21},"2026-08",{"date":413,"type":21},"2031-02",{"name":415,"class":45},"Brigham and Women's Hospital",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":423,"enrollmentInfo":424,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":4},"100647996","association-between-metabolic-associated-fatty-liver-disease-and-obstructive-sleep-apnea-100647996","NCT07716995","Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea","OSA\u002FMAFLD","Inclusion Criteria:\n\n* Patients aged \\>18 years old\n* presented with a clinical suspicion of sleep-disordered breathing, including snoring, sleepiness and witnessed sleep apnea\n\nExclusion Criteria:\n\n* Patients aged ≤18 years old\n* Pregnancy\n* Presence of malignancy\n* Type I DM\n* Patients with fatty liver who undergone bariatric surgeries.\n* Patients with Central sleep apnea, upper airway resistance and narcolepsy\n* Patients with lung diseases with hypoxia\n* Previous history of alcohol consumption, steroids, proton pump inhibitors, antibiotics, and contraceptive pills","60 Years",{"count":425,"type":21},127,"Association between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea",[28,428],"Metabolic Dysfunction-Associated Steatotic Liver Disease","2026-07-21",{"date":431,"type":38},"2026-07-22",{"date":433,"type":21},"2026-08-01",{"date":435,"type":21},"2027-09-01",{"name":437,"class":45},"Assiut University",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":445,"sex":17,"minAge":84,"maxAge":244,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":454,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":467,"locationsCount":46},"100648411","identification-of-biomarkers-of-obstructive-sleep-apnea-100648411","NCT07723144","Identification of Biomarkers of Obstructive Sleep Apnea.","Identification of Biomarkers to Understand the Pathogenesis of Obstructive Sleep Apnea.","Inclusion Criteria:\n\n1. Participants with obstructive sleep apnea (OSA):\n\n   * Age 18 to 65 years.\n   * Moderate or severe obstructive sleep apnea confirmed by overnight polysomnography (apnea-hypopnea index \\[AHI\\] ≥15 events\u002Fhour).\n   * Willing and able to provide written informed consent.\n   * Willing to undergo repeated blood sampling and study assessments.\n   * Willing to use positive airway pressure (PAP) therapy and accept random assignment to immediate or delayed treatment.\n2. Control participants:\n\n   * Age 18 to 65 years.\n   * No obstructive sleep apnea (AHI \\\u003C5 events\u002Fhour on overnight polysomnography).\n   * Willing and able to provide written informed consent.\n   * Willing to undergo study assessments and blood sampling.\n\nExclusion Criteria:\n\n* Mild obstructive sleep apnea (AHI 5 to \\\u003C15 events\u002Fhour).\n* Central sleep apnea.\n* Previous treatment for obstructive sleep apnea within the previous 3 months.\n* Body mass index (BMI) ≥40 kg\u002Fm².\n* Severe cardiovascular disease.\n* Severe kidney disease or impaired renal function.\n* Significant liver disease.\n* Chronic inflammatory, autoimmune, or rheumatic disease.\n* Active cancer or other condition associated with systemic inflammation.\n* Chronic respiratory diseases, including asthma or chronic obstructive pulmonary disease.\n* Respiratory infection within 4 weeks before enrollment.\n* Major surgery or significant injury within the previous 3 months.\n* Chronic rhinosinusitis.\n* Current treatment with systemic corticosteroids, immunosuppressive drugs, cytotoxic drugs, chronic anti-inflammatory medications, or other medications that may influence inflammatory biomarkers.\n* Pregnancy or any condition that, in the opinion of the investigators, would make participation unsafe or interfere with interpretation of the study results.",true,{"count":246,"type":21},[24],"Obstructive sleep apnea (OSA) is a common sleep disorder associated with intermittent hypoxia, systemic inflammation, oxidative stress, and an increased risk of cardiovascular and metabolic diseases. Current diagnostic methods are effective but have limited availability and do not adequately predict disease burden or treatment response.\n\nThe purpose of this study is to identify and validate blood biomarkers that may improve the screening, diagnosis, risk stratification, and monitoring of adults with OSA. A total of 120 participants will undergo clinical evaluation and overnight polysomnography. Participants with moderate-to-severe OSA will be randomly assigned to either immediate or delayed positive airway pressure (PAP) therapy, while participants without OSA will serve as controls. Blood samples will be collected at predefined time points and analyzed for inflammatory, metabolic, oxidative stress, and other candidate biomarkers.\n\nThe study aims to determine which biomarkers are associated with OSA severity and how they change in response to PAP therapy. The results may contribute to the development of more accessible and personalized diagnostic and monitoring strategies for patients with OSA.",[28,450,451,452,453],"Obstructive Sleep Apnea (OSA)","Obstructive Sleep Apnea (OSAS)","Obstructive Sleep Apnea (SAOS)","Obstructive Sleep Apnea (Moderate to Severe)",[154,155,455,285,456,457,458,459,460,461],"Positive airway pressure therapy","Blood biomarkers","Polysomnography","Inflammation","Oxidative stress","Metabolomics","Precision medicine","2026-07-20",{"date":407,"type":38},{"date":335,"type":38},{"date":466,"type":21},"2029-06-19",{"name":468,"class":45},"Medical University of Bialystok",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":100},"100546085","functional-improvement-in-osa-and-copd-with-a-telehealth-lifestyle-and-exercise-intervention-100546085","NCT06390345","Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention","FOCuSEd","Inclusion Criteria:\n\n* COPD: Defined by presence of airflow obstruction (FEV1\u002FFVC \\\u003C 0.70) on post-bronchodilator spirometry\n* ≥10 pack year history of tobacco use\n* Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)\n* BMI ≥ 25 kg\u002Fm2\n* Symptoms of dyspnea defined by MMRC score of ≥1\n\nExclusion Criteria:\n\n* Self-report of weight change \\>15 lbs. during prior 3 months\n* Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.\n* Severe illness from any cause\n* Diagnosis of bulimia or history of purging behavior\n* Active enrollment in pulmonary rehabilitation\n* Safety and\u002For adherence concerns due to severe physical or mental health issues or life expectancy \\\u003C 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.\n* Pregnant, lactating, or planning to become pregnant during the study period\n* Participation in other intervention studies.\n* Prisoner\n* Unable to complete surveys in English",{"count":477,"type":21},400,[24],"The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or \"enhanced\" usual care, stratifying by age (≥65 vs. \\\u003C 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the \"enhanced\" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.",[481,28,482],"Chronic Obstructive Pulmonary Disease","Overweight and Obesity",{"date":431,"type":38},{"date":485,"type":38},"2024-07-29",{"date":487,"type":21},"2028-10-01",{"name":489,"class":45},"Seattle Institute for Biomedical and Clinical Research",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":4},"100619341","transcutaneous-electrical-stimulation-in-patients-with-obstructive-sleep-apnoea-100619341","NCT07343362","Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea","Zeus Sleep Technology: A UK-based Multi-centre Randomised Controlled Trial Using Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea (TESLA)","TESLA-MICRON","Inclusion Criteria:\n\n1. Adult participants (≥18 years) who have OSA with an AHI between 5-40 events\u002Fhour, as measured by the baseline sleep study (3 nights off CPAP).\n2. If the participant fails to use CPAP sufficiently, defined as use of CPAP for less than 4 hours\u002Fnight on fewer than 70% of nights over a minimum period of 3 months prior to enrolment.\n3. Adults with a body mass index (BMI) of 18.5-32.0 kg\u002Fm2 (inclusive)\n4. Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils).\n5. Able and willing to provide informed written consent.\n6. Access to a smartphone and internet at home.\n\nExclusion Criteria:\n\n1. Hypercapnic patients (pCO2\\>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- \\>28mmol\u002FL).\n2. Adults with significantly enlarged tonsils (size 3-4)\n3. Adults with polyps or adenoids, hypoglossal nerve palsy,\n4. Adults with notable medical co-morbidities that could potentially impact participation in or the achievement of the study's objectives (e.g., significant heart failure (New York Heart Association, NYHA class III-IV), recent myocardial infarction (within 3 months) and significant cardiac arrhythmias, uncontrolled hypertension).\n5. Participants with an active psychiatric condition that, in the opinion of the Investigator, may affect the participant's capacity to provide informed consent, adhere to study procedures, actively participate in the study, or compromise the integrity of study data.\n6. Participants with active implantable medical devices, including but not limited to cardiac pacemakers, implantable cardioverter defibrillators (ICDs), cochlear implants, deep brain stimulation (DBS) systems, vagus nerve stimulation (VNS) devices, neurostimulators, or implanted infusion pumps.\n7. Participants with metallic implants in the head or neck region that, in the opinion of the Investigator, may interfere with the safe use of the investigational device.\n8. Participants who are physically incapacitated such as to manoeuvre the ZeusOSA device\n9. Adults with long facial hair that interferes with the correct placement of the hydrogel pad, and who are unwilling to shave.\n10. Participants with an allergy to plasters or similar products.",{"count":499,"type":21},186,[24],"The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous positive airway pressure (CPAP) therapy over a period of 3-months in the community and compare results against usual care (ongoing CPAP therapy), evaluate acceptability, comfort and adverse events, and record outcomes for provision of the health economics analysis. The proposed study will provide us with data about the efficacy of the domiciliary use of the intervention from a UK-based prospective, multi-centre and randomised controlled trial (Phase III). We will understand whether the primary outcome parameter, the apnoea hypopnea index (AHI), or the secondary outcomes (e.g. 4% oxygen desaturation index (ODI), the Epworth Sleepiness Scale (ESS), compliance and comfort, Functional Outcome of Sleep Questionnaires (FOSQ), European Quality of Life Questionnaire (EQ-5D)) are suitable measures to assess control of OSA using TESLA within reasonable acceptance for the patients to provide the analysis of healthcare resource usage for assessment of cost-efficacy and quality-adjusted life years (QALYs). Responder analysis will provide insights into gender, socio-economic background and endotypes to predict who most suitably benefits from this treatment.",[28],[285,504,505,506,507,496,508,509,510],"Continuous Positive Airway Pressure","Hypoglossal Nerve Stimulation","non-CPAP therapy","sleep-disordered breathing","Zeus Sleep Technology","transcutaneous electrical stimulation","Zeus Sleep Ltd","2026-07-17",{"date":429,"type":38},{"date":514,"type":21},"2026-07-16",{"date":516,"type":21},"2028-09",{"name":510,"class":99},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":197,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":46},"100461818","phase-1-rescue-pharmacotherapy-for-osa-100461818","NCT05293600","Rescue Pharmacotherapy for OSA","Treating Residual OSA With Endotype-directed Pharmacotherapy (Aim 3)","RescOSA","Inclusion Criteria:\n\n* Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events\u002Fhr on MAD or HGNS therapy.\n\nExclusion Criteria:\n\n* Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:\n\ncentral sleep apnea (\\>50% of respiratory events scored as central), chronic hypoventilation\u002Fhypoxemia (awake SaO2 \\\u003C 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.\n\n* Other sleep disorders: periodic limb movements (periodic limb movement index \\> 20\u002Fhr), narcolepsy, or parasomnias.\n* Any unstable major medical condition.\n* Medications expected to stimulate or depress respiration (including opioids, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).\n* Use of SSRIs\u002FSNRIs.\n* Contraindications for atomoxetine, including:\n* pheochromocytoma\n* use of monoamine oxidase inhibitors\n* benign prostatic hypertrophy, urinary retention\n* untreated narrow angle glaucoma\n* bipolar disorder, mania, psychosis\n* clinically significant constipation, gastric retention\n* pre-existing seizure disorders\n* clinically-significant kidney disorders\n* clinically-significant liver disorders\n* clinically-significant cardiovascular conditions\n* severe hypertension (SBP\\>180 mmHg or DBP\\>110 mmHg measured at baseline)\n* cardiomyopathy (LVEF\\\u003C50%) or heart failure\n* advanced atherosclerosi\n* history of cerebrovascular events\n* history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation\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\n* Contraindications for eszopiclone, including:\n* Hypersensitivity to eszopiclone\n* Chronic Obstructive Pulmonary Disease (COPD)\n* Pregnancy\n* Breast feeding\n* Liver disease\n* Contraindications for acetazolamide, including:\n* Hyperchloremic acidosis\n* Hypokalemia\n* Hyponatremia\n* Adrenal insufficiency\n* Impaired kidney function\n* Hypersensitivity to acetazolamide or other sulfonamides.\n* Marked liver disease or impairment of liver function, including cirrhosis.\n* Contraindications for trazodone, including:\n* suicidal ideation\n* bipolar disorder, mania\n* use of monoamine oxidase inhibitors\n* coronary artery disease\n* cardiac arrhythmias\n* QT prolongation\n* hepatic disease\n* renal failure or impairment\n* closed angle glaucoma\n* priapism\n* pregnancy\u002Fbreast-feeding",{"count":527,"type":21},70,[248,201],"Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of undertreated OSA. In this study, the investigators want to test the addition of a drug treatment to their regimen. Endotypes will be targeted pharmacologically with one of the following drugs: acetazolamide for a high loop gain, atomoxetine-plus-eszopiclone for poor pharyngeal muscle compensation, or trazodone for a low arousal threshold.\n\nThis aim is expected to provide treatment strategies for rescuing non-responders to MAD or HGNS therapy.",[28],"2026-07-14",{"date":533,"type":38},"2026-07-15",{"date":535,"type":38},"2023-07-01",{"date":537,"type":21},"2026-10-30",{"name":415,"class":45},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":46},"100559497","comparative-assessment-of-sleep-positive-airway-pressure-modalities-caspam-100559497","NCT06564896","Comparative Assessment of Sleep Positive Airway Pressure Modalities (CASPAM)","Comparative Assessment of Sleep Positive Airway Pressure Modalities (CASPAM) Trial: Conventional CPAP (AirSense 10) Versus Portable CPAP (AirMini) in Patients With Obstructive Sleep Apnea-A Randomized Crossover Study of User Preference","CASPAM","Inclusion Criteria:\n\n* Aged ≥ 18 years.\n* Patients diagnosed with moderate to severe OSA (based on AHI classification from sleep study performed).\n* Patients who are able to understand and answer the questionnaire given.\n\nExclusion Criteria:\n\n* Patients who are unable to give consent to the study.\n* Patients who have been diagnosed with OSA and already on CPAP machine.\n* Patients who had underlying Obesity Hypoventilation Syndrome (OHS).\n* Patients who had underlying co-morbidities that worsen apnea symptoms, such as congestive cardiac failure, active malignancy, narcolepsy, active alcohol or drug abuse, treatment-refractory dementia, psychotic illness and active use of drugs that disturb the sleep architecture (i.e hypnotics or stimulants of central nervous system).",{"count":548,"type":21},50,[24],"Obstructive sleep apnea (OSA) has been one of the topmost global health problems. It is an underdiagnosed disease which have a huge burden on healthcare if left untreated. Almost 80-90% of adults are underdiagnosed of OSA Obesity primarily is one of the supreme risk factors for developing OSA. Globally, obesity cases have risen affecting almost two billion people. According to National Health and Morbidity Survey (NHMS) 2019, 1 in 2 adults in Malaysia were overweight or obese. Report from World Obesity Atlas 2023 predicts that adult obesity will rise 4.7% annually from 2020 - 2035, while child obesity will increase by 5.3% per year over similar timeline. Overweight individuals will have a significant economic impact on Malaysia's Gross Domestic Product (GDP) by 2035 by 2.8% which is estimated to be about RM 3.2 trillion.\n\nSequalae of OSA is divided into two (cardiovascular-metabolic effect and neurocognitive effect). This group of patients are at high risk of developing hypertension, insulin resistance, dyslipidemia which then leads to pulmonary hypertension and heart failure. More importantly, from the neurocognitive point of view, persistent sleep deprivation will lead to poor concentration, impaired memory, personality changes affecting overall self-performance which can lead to depression and compromising safety as they have higher risk of work-related accidents.",[28],"2026-07-13",{"date":531,"type":38},{"date":555,"type":38},"2024-09-01",{"date":557,"type":21},"2027-01-01",{"name":559,"class":45},"National University of Malaysia",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":197,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":46},"100466168","phase-1-atomoxetine-and-daw2022-on-osa-severity-100466168","NCT05350215","Atomoxetine and DAW2022 on OSA Severity","Effect of Atomoxetine and DAW2022 on OSA Severity","Inclusion Criteria:\n\n* Moderate-to-severe OSA (AHI ≥ 15 events\u002Fhr)\n\nExclusion Criteria:\n\n* All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.\n* Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).\n* Use of SNRIs\u002FSSRIs.\n* Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.\n* Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:\n* Other sleep disorders: periodic limb movements (periodic limb movement arousal index \\> 10\u002Fhr), narcolepsy, or parasomnias.\n* Hypersensitivity to the study drug (angioedema or urticaria)\n* Contraindications to DAW2020\n* Use of medications that lengthen QTc interval\n* Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease\n* Severe claustrophobia.",{"count":568,"type":21},18,[248,201],"Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, DAW2020, a hypnotic which prolonged the total sleep time in a previous trial in OSA patients, could be a better candidate to associate with atomoxetine.",[28],"2026-07-09",{"date":574,"type":38},"2026-07-10",{"date":576,"type":38},"2022-06-01",{"date":578,"type":21},"2026-12-01",{"name":415,"class":45},{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":587,"maxAge":373,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":189},"100535977","treatment-of-obstructive-sleep-apnea-with-personalized-surgery-in-children-with-small-tonsils-100535977","NCT06258837","Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils","TOPS-ST","To be in the study:\n\n* Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5).\n* Child age is 2.00 to 17.99 years of age.\n* Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam.\n* Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.\n* Caregiver can speak, read, and write in English or Spanish.\n* Caregiver is primary caretaker of the child.\n* Child is not expecting their own child.\n* Child is eligible for surgical treatment\n\nCannot be in the study if:\n\n* Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.\n* Child has any contraindication to surgery (e.g. bleeding disorders).\n* Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence.\n* Child has a genetic abnormality, Down syndrome, neuromuscular disorder, craniofacial anomaly.\n* Caregiver is unwilling or unable to comply with study procedures.\n* Child is or plans to become a parent themselves.","2 Years",{"count":589,"type":21},175,[24],"The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (DISE)-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with ST will perform better than the currently recommended standard first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT. To test this hypothesis, the investigators propose to study children aged 2-17 years with small tonsils and OSA.",[593,28],"Otolaryngological Disease","2026-07-02",{"date":596,"type":38},"2026-07-06",{"date":598,"type":38},"2024-10-04",{"date":600,"type":21},"2028-09-30",{"name":602,"class":45},"Oregon Health and Science University",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":587,"maxAge":373,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":621},"100478361","treatment-of-obstructive-sleep-apnea-with-personalized-surgery-in-children-with-down-syndrome-tops-ds-100478361","NCT05508971","Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)","TOPS-DS","Requirements to participate in study:\n\nChild has a diagnosis of Down syndrome (Trisomy 21). Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5). Child age is 2.00 to 17.99 years of age. Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.\n\nCaregiver can speak, read, and write in English or Spanish. Caregiver is primary caretaker of the child. Child is not expecting their own child. Child is eligible for surgical treatment\n\nCannot participate in study if:\n\nChild has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.\n\nChild has any contraindication to surgery (e.g. bleeding disorders). Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence.\n\nCaregiver is unwilling or unable to comply with study procedures. Child is or plans to have their own child.",{"count":611,"type":21},304,[24],"The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untreated OSA in children has been associated with daytime sleepiness, cognitive or behavioral problems, and cardiovascular complications, all which are common in children with DS. Adenotonsillectomy (AT) is the first line treatment for OSA in children, however, most large studies of AT outcomes have excluded children with DS. Available evidence demonstrates that AT is far less effective in children with DS than in the general pediatric population, with 48 to 95% of children with DS having persistent OSA after AT. Medical treatments such as positive airway pressure (PAP) therapy are frequently inadequate or poorly tolerated in this population, so many children with DS and OSA remain untreated. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of obstruction during sedated sleep using a flexible endoscope passed through the nose into the pharynx. DISE was developed to guide surgical decisions in adult OSA, and in recent years has also been used to design personalized surgical interventions in children. Using this DISE Rating Scale, the investigators have demonstrated that children with DS are more prone to tongue base and supraglottic obstruction than non-DS children, suggesting the need for more personalized surgical treatments that are tailored to the common sources of obstruction in this population. Several small case series demonstrate that DISE-directed surgery can be effective in treating OSA in children with DS. However, because there have been few prospective studies and no randomized trials comparing different treatment options in this population, there remains uncertainty about whether such a personalized approach leads to superior outcomes compared to the first line AT.\n\nIt is the investigators' hypothesis that personalized DISE-directed surgery that uses existing procedures to address specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the current first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT.",[28,118],{"date":596,"type":38},{"date":617,"type":38},"2023-08-02",{"date":619,"type":21},"2028-06-30",{"name":602,"class":45},7,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":22,"phases":630,"briefSummary":631,"conditions":632,"keywords":633,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":189},"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.",{"count":629,"type":21},150,[201],"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).",[28],[634,635,636],"surgery","loop gain","arousal threshold","2026-06-29",{"date":639,"type":38},"2026-07-01",{"date":641,"type":38},"2024-01-07",{"date":643,"type":21},"2028-08-31",{"name":645,"class":45},"University of California, Los Angeles"]