[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osa---obstructive-sleep-apnea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osa---obstructive-sleep-apnea":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,49,80,112,142,167,193,221,240,270,292,322,350,371,403,434,455,480],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100571630","stroke-and-cpap-outcome-study-3-randomized-controlled-trial-100571630",false,"NCT06722755","Stroke and CPAP Outcome Study 3 Randomized Controlled Trial","Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation","SCOUTS3","Inclusion criteria include:\n\n1. Age 18 years or older\n2. Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days\n3. Person providing consent (patient or legally authorized representative (LAR)) able to be consented in English or Spanish.\n\nExclusion criteria include:\n\n1. Unable to obtain informed consent from participant or LAR in English or Spanish\n2. Incarcerated\n3. Known pregnancy-determined by reviewing clinical data\n4. Current mechanical ventilation, tracheostomy, or supplemental oxygen use \\> 4L\u002Fmin\n5. Use of positive airway pressure within 14 days prior to stroke\n6. History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use\n7. Stroke related to tumors, vascular malformations or subarachnoid hemorrhage\n8. Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) including any benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the planned portable sleep apnea study\n9. Anticipated inpatient rehabilitation length of stay \\\u003C 5 nights\n10. Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team\n11. Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months\n12. Patients at significant risk of aspiration that could render the patient at risk of harm from use of CPAP, in the opinion of the site PI.","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"NA","The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR).\n\nThe study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.",[27,28,29],"Stroke Patients","CPAP","OSA - Obstructive Sleep Apnea",[31,32,33,34,35],"behavioral therapy","continuous positive airway pressure","stroke recovery","self determination","sleep apnea","RECRUITING","2026-08-11",{"date":39,"type":40},"2026-08-13","ACTUAL",{"date":42,"type":40},"2025-01-15",{"date":44,"type":21},"2028-05",{"name":46,"class":47},"University of Washington","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100649312","miniscrew-assisted-rapid-palatal-expansion-for-obstructive-sleep-apnea-100649312","NCT07734688","Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea","The Effectiveness of Miniscrew-Assisted Rapid Palatal Expansion in the Management of Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. AHI ≥ 5\n2. Aged ≥ 16 and ≤ 60 years old\n3. Presence of the upper first permanent molars\n4. Presence of unilateral or bilateral posterior crossbite or maxillary transverse deficiency (considering intermolar width measurements, posterior teeth buccolingual incli- nation, and posterior crossbites) allowing meaningful maxillary expansion of at least 5mm\n5. Willingness to undergo MARPE treatment under the standard fee structure of the Faculty of Dentistry, Universiti Malaya\n\nExclusion Criteria:\n\n1. BMI ≥ 30 kg\u002Fm2\n2. Basic Periodontal Examination (BPE) ≥ 3 or BPE markers\\* (root bifurcation lesions)\n3. Mobile teeth (Mobility grade ≥ 1)\n4. Pathology in the maxilla, such as substantial maxillary bone defects, or maxillary bone defects due to space-occupying cysts, tumors, etc.\n5. Significant true skeletal asymmetry\n6. Presence of significant root resorption of upper first permanent molars due to previous orthodontic treatments\n7. Concurrent on-going treatment for OSA such CPAP\n8. Previous treatment for OSA such as soft tissue or hard tissue surgery within the past 4 months\n9. Significant mandibular retrognathic (SNB less than normal value cephalometrically)\n10. General chronic medical illnesses like cardiac failure, kidney failure, stroke etc.\n11. Medication\n12. Syndromic\n13. Presence of neuropsychiatric illnesses such insomnia, narcolepsy, parasomnia etc.\n14. Presence of neuromuscular diseases such multiple schlerosis, epilepsy, Parkinson's disease.\n\n    \\-","16 Years","60 Years",{"count":59,"type":21},24,[24],"The goal of this clinical trial is to learn whether miniscrew-assisted rapid palatal expansion (MARPE) can improve obstructive sleep apnea (OSA) in late adolescents and adults aged 16 to 60 years. The main questions it aims to answer are:\n\n1. Does MARPE improve sleep apnea severity, as measured by Home Sleep Apnea Testing (HSAT), including respiratory event index (REI), oxygen desaturation index (ODI), mean oxygen saturation, nadir oxygen saturation, snoring events, and body position?\n2. Does MARPE improve breathing and sleep-related symptoms, including upper airway dimensions, daytime sleepiness, quality of life, and peak nasal inspiratory flow (PNIF)?\n\nResearchers will compare a MARPE group with a control group that receives standard care for obstructive sleep apnea for 3 months to see whether MARPE provides additional benefit.\n\nParticipants will:\n\n1. Receive standard care for obstructive sleep apnea\n2. Be randomly assigned to either MARPE plus standard care or standard care alone for 3 months\n3. In the MARPE group, wear a miniscrew-assisted rapid palatal expander and activate it according to the study protocol\n4. Visit the clinic for follow-up care and monitoring\n5. Data will be collected at baseline (T0) and 3 months (T1). At both time points, participants in the MARPE group will be assessed using Home Sleep Apnea Testing (HSAT), cone beam computed tomography (CBCT), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10), and peak nasal inspiratory flow (PNIF). Participants in the control group will be assessed using HSAT, ESS, FOSQ-10, and PNIF.",[29,63],"Palatal Expansion Technique",[65,66,67,68,69],"obstructive sleep apnea","miniscrew-assisted rapid palatal expansion","MARPE","adult","palatal expansion technique","NOT_YET_RECRUITING","2026-07-23",{"date":73,"type":40},"2026-07-29",{"date":75,"type":21},"2026-08-01",{"date":77,"type":21},"2027-02-20",{"name":79,"class":47},"University of Malaya",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100646853","phase-1-the-optimal-one-month-dosing-of-lemborexant-for-moderate-obstructive-sleep-apnea-osa-patients-with-low-arousal-threshold-100646853","NCT07683442","The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold","One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial","LMOSALAT","Inclusion criteria\n\nIndividuals are eligible for participation in this study if they have all of the followings:\n\n1. Patient, aged 18 - 65 years at the time of informed consent\n2. Voluntary agreement and capable for giving written informed consent\n3. Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision\n4. Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events\u002Fh of sleep (moderate severity)\n5. Patients identified as low arousal threshold using previously recommended criteria which allocated a score of 1 to each criterion: apnea-hypopnea index \\\u003C 30 events per hour, nadir oxygen saturation as measured by pulse oximetry \\> 82.5%, and fraction of hypopneas \\> 58.3%. A score of 2 or above defined a low arousal threshold.\n6. Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit\n7. Habitually sleeping ≥ 5.5 hours\u002Fnight with usual bedtime falls within the range of 9:00 PM to 1:00 AM\n8. Body mass index 18 - 40 kg\u002Fm2 Exclusion criteria\n\nIndividuals were not eligible for participation in this study if they have any of the followings:\n\n1. Previous allergy or adverse effects with Lemborexant or other sedatives\n2. Pregnant or breastfeeding\n3. Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion\n4. Uncontrolled cardiovascular or cerebrovascular diseases\n5. Neuromuscular diseases\n6. Nasal anatomical defect\n7. Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion\n8. Active respiratory disorders other than OSA\n9. Central respiratory events (CAHI) \\>25% of the total AHI\n10. Diagnosis\u002Fsymptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder\n11. Severe hypersomnolence (ESS ≥16)\n12. Peripheral capillary oxygen saturation (SpO2) \\\u003C 80% for ≥ 5% of total sleep time measured during screening visit\n13. Driving-related sleepiness accident or near misses in the past 12 months\n14. Safety-critical occupation\n15. Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study\n16. Unable to tolerate equipment in this study\n17. Taking any medication that affects sleep or other variable measured in this study\n18. Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers\n19. Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake\n20. Excessive caffeine intake","65 Years",{"count":90,"type":21},36,[92,93],"PHASE1","PHASE2","The goal of this clinical trial is to investigate the 1-month treatment effects of different dose of lemborexant in moderate OSA adult patients (18-65 years of age) with low arousal threshold.\n\nThe main questions it aims to answer are:\n\nPrimary outcome measure: Apnea\u002Fhypopnea index (AHI)\n\nSecondary outcome measure:\n\n1. Polysomnography parameters\n\n   * Mean and nadir oxygen saturation\n   * Sleep efficiency\n   * Wake after sleep onset (WASO)\n   * Sleep latency\n   * Rapid eye movement (REM) latency\n   * Percentage of time spent in Non-rapid eye movement (NREM) stage 1-3 and REM stage\n   * Arousal index\n2. Oxford Sleep Resistance Test (OSLER) test\n3. Epworth Sleepiness Scale (ESS)\n4. Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)\n5. Pittsburgh Sleep Quality Index (PSQI)\n6. Actigraphy parameters\n\n   * Total sleep time\n   * Sleep efficiency\n   * Wake after sleep onset (WASO)\n   * Sleep latency\n7. Sleep diary parameters (Appendix 5)\n\n   * Total sleep time\n   * Sleep efficiency\n   * Wake after sleep onset (WASO)\n   * Sleep latency\n   * Sleep quality\n\nResearchers will compare placebo to see if there is a difference in AHI.\n\nParticipants will\n\n* participate a total of 3 phases of study (3-crossover trial)\n* each phrase the participants will receive either lemborexant 5 mg, lemborexant 10 mg, or placebo orally per day for 30 days with 2-week washout (depend on intervention arm whether the participants receive which intervention sequence)\n* complete three overnight in-laboratory polysomnography (2-week washout) at day 30 of each phrase\n* monitor actigraphy during day 1 to 29 of intervention of all periods\n* record sleep diary during day 1 to 29 of intervention of all periods\n* complete the OSLER test in the morning of the three overnight test\n* complete questionnaires including: Epworth Sleepiness Scale (ESS), Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T), Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention) and the night before overnight in-laboratory polysomnography",[29],[97,98,99,100,101],"Apnea\u002FHypopnea Index (AHI)","Lemborexant","Obstructive Sleep Apnea (OSA)","Low Arousal Threshold","Polysomnography","2026-07-02",{"date":104,"type":40},"2026-07-06",{"date":106,"type":21},"2026-09-01",{"date":108,"type":21},"2028-06-30",{"name":110,"class":47},"Chulalongkorn University",1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":48},"100640198","serene-sleep-palatal-implant-system-clinical-confirmatory-trial-in-participants-who-snore-or-are-diagnosed-with-mild-to-moderate-obstructive-sleep-apnea-osa-100640198","NCT07613281","Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).","A Prospective, Non-Randomized, Multi-Center, Two-Arm Study Evaluating the Serene Sleep Palatal Implant System","INCLUSION CRITERIA\n\nA potential participant must meet ALL the following criteria to be enrolled into this study:\n\n1. Participant is ≥18 years of age.\n2. Participant has Body Mass Index (BMI) less than or equal to 30 kg\u002Fm²\n3. Participant has a tonsil grade less than or equal to 2\n4. Participant has a Friedman Tongue Position (FTP) I or II\n5. Participant is able to provide voluntary written informed consent.\n\nFor a snoring participant to be selected for the study:\n\n* Confirmed identification of palatal snoring\n\n  * Investigators will utilize standard of care clinical assessment methods to confirm the presence of palatal snoring prior to enrollment. These methods may include patient-reported history, physical examination of the upper airway, and auscultation or audio recordings.\n* Confirmed elimination of potential sleep apnea diagnosis\n\n  * If the evaluating doctor suspects that the participant may be experiencing OSA, investigators will utilize standard of care clinical assessment methods to confirm OSA.\n  * A resulting AHI \\\u003C5 would classify the participant as an eligible snoring subject\n\nFor an OSA participant to be selected for study:\n\nConfirmed identification of apnea caused by palatal collapse\n\n* Investigators should be able to make this identification through intraoral evaluation in accordance with their standard of care\n* Confirmed mild-to-moderate classification of OSA\n\n  * If the evaluating investigator knows or suspects that the participant may be experiencing OSA, standard of care diagnostic methods will be used as confirmation.\n  * A resulting AHI between 5 and 30 would classify the participant as an eligible OSA subject.\n\nEXCLUSION CRITERIA\n\nA potential participant will be excluded from enrollment if ANY of the following conditions apply:\n\n1. A record of allergic reaction to polyethylene terephthalate (PET) \u002F polyester\n2. An overly sensitive gag reflex\n3. Septal deviation or nasal obstruction\n4. Nasal polyps\n5. Severe seasonal allergies\n6. Soft palate length insufficient to accommodate implants\n7. Prior Diagnosis of Lingual tonsil hypertrophy\n8. Hypopharyngeal obstruction\n9. Previous pharyngeal surgery\n10. Previous upper respiratory tract cancer or radiation therapy\n11. Active respiratory tract infection\n12. Dysphagia or speech disorder\n13. Neurologic disorder\n14. Unstable psychiatric disorder\n15. Pregnant or breastfeeding\n16. History of falling asleep driving or Motor Vehicle Accident (MVA) due to sleepiness\n17. Clinical Presentation that suggests Severe OSAHS (ESS \\>20, participant report of choking or gasping during sleep, etc.)\n18. Marfan's Syndrome, Ehler-Danlos syndromes or other disorders of connective tissue and\u002For muscular tissue\n19. Other sleep disorders\n20. Other significant craniofacial anomaly\n21. Participant is participating in any of the following:\n\n    * A study with the same or similar primary endpoint\n    * Any study in which the investigator determines may interfere with the results of this study\n22. Participant is unwilling to complete all study related assessments and follow-up visits\n23. Participant is unwilling or unable to abstain from all alcohol consumption for 24 hours leading up to the intake sleep study\n24. Participant is unwilling or unable to abstain from all smoking, vaping, and\u002For oral tobacco products for 48 hours following the procedure\n25. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results",{"count":120,"type":21},26,[24],"This clinical investigation is a prospective, non-randomized, parallel-group clinical investigation conducted at two (2) investigative sites. Study participants will be assigned to one of two study groups, snoring and obstructive sleep apnea, in a parallel manner based on predefined eligibility criteria.\n\nThe study aims to evaluate and compare outcomes between the two groups under investigation. The primary endpoint for this study is to evaluate the adverse event profile of the Serene Sleep Palatal Implants, in comparison to those observed with the previously marketed Pillar Palatal Implants, in subjects treated for snoring and\u002For mild-to-moderate OSA.\n\nThe design allows for the concurrent enrollment and follow-up of participants in both arms, enabling direct observation of differences in safety across the groups over time.",[124,29],"Snoring",[124,126,127,128,129,130,131],"Obstructive Sleep Apnea","Sleep Apnea","Hypopnea","Sleep-Disordered Breathing","Sleep Implant","Airway Support Implant","2026-05-29",{"date":134,"type":40},"2026-06-01",{"date":136,"type":21},"2026-06",{"date":138,"type":21},"2026-10",{"name":140,"class":141},"Serene Sleep, Inc.","INDUSTRY",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":111},"100605311","obstructive-sleep-apnoea-and-difficult-asthma-osada-100605311","NCT07160868","Obstructive Sleep Apnoea and Difficult Asthma (OSADA)","Open-label Randomized Controlled Trial Investigating the Relationship Between Obstructive Sleep Apnoea and Difficult Asthma","OSADA","Inclusion Criteria:\n\n* Patients must have a clinical diagnosis of asthma with supportive objective diagnostics including but not limited to, variable airflow obstruction, bronchial-hyper responsiveness and demonstrable eosinophilic inflammation via fractional exhaled nitric oxide or peripheral eosinophilia\n* Patients receiving step 4 or step 5 of 'The Global Initiative for Asthma' (GINA) treatment guidelines will be selected\n* Between the ages of 18 to 90 years of age\n\nExclusion Criteria:\n\n* Patients with previous sleep study investigations\n* Excessive daytime sleepiness; ESS \\>17\n* Previous diagnosis of a sleep disorder\n* Resting hypoxaemia or need for long-term oxygen therapy\n* Inability to provide informed consent","90 Years",{"count":152,"type":21},80,[24],"The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma.\n\nParticipants will undergo home-based sleep studies to assess for OSA and are then allocated to one of three arms: 1) Patients with OSA treated with CPAP (intervention group), 2) Patients with OSA not treated for OSA (control group) and 3) Patients without OSA (reference group).\n\nThe primary objective is to evaluate whether treating OSA improves asthma control, symptom burden, and quality of life compared to untreated OSA and to patients without OSA. Secondary outcomes include exacerbation rates, sleep quality, and healthcare utilization.\n\nThis trial aims to clarify the contribution of OSA to poor asthma control and the potential benefits of integrated sleep and respiratory care in this complex population.",[156,29,157],"Asthma (Diagnosis)","CPAP Treatment","2026-05-20",{"date":160,"type":40},"2026-05-26",{"date":162,"type":40},"2025-09-01",{"date":164,"type":21},"2026-05-22",{"name":166,"class":47},"St. James's Hospital, Ireland",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":48},"100621878","comparative-study-of-cpap-predictive-equations-and-in-laboratory-manual-titration-in-thai-patients-with-obstructive-sleep-apnea-100621878","NCT07376343","Comparative Study of CPAP Predictive Equations and In-laboratory Manual Titration in Thai Patients With Obstructive Sleep Apnea","Inclusion Criteria:\n\n* Suspected OSA\n* Undergoing an in-laboratory sleep study\n\nExclusion Criteria:\n\n* No indication for in-laboratory manual CPAP titration\n* Failure to determine an optimal CPAP pressure during in-laboratory manual CPAP titration",{"count":174,"type":21},150,"OBSERVATIONAL","The goal of this observational study is to compare predictive equations for continuous positive airway pressure (CPAP) with in-laboratory manual titration in patients with obstructive sleep apnea (OSA).\n\nThe main question the study aims to answer is:\n\nWhich CPAP predictive equation best predicts the optimal CPAP pressure in OSA patients in Thailand? Participants will undergo an in-laboratory sleep study.",[29],[179,65,28,32,180,181,182,183],"OSA","equation","Thailand","sleep test","polysomnography","2026-04-15",{"date":186,"type":40},"2026-04-17",{"date":188,"type":40},"2026-02-01",{"date":190,"type":21},"2026-12-31",{"name":192,"class":47},"Thammasat University",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":111},"100626316","phase-3-a-study-of-xw003-in-obese-participants-with-obstructive-sleep-apnea-receiving-positive-airway-pressure-therapy-100626316","NCT07434050","A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy","A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of XW003 Injections in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy","Inclusion Criteria:\n\n1. Body mass index (BMI) ≥ 28.0 kg\u002Fm2;\n2. The results of PSG meet the diagnosis criteria of OSA and with an AHI≥15 at screening;\n3. Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study;\n4. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n1. History of endocrine disorders which have significant impact on body weight;\n2. Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state\u002Fcoma;\n3. HbA1c ≥6.5% at screening;\n4. Fasting blood glucose ≥7.0 mmol\u002FL or 2-hour blood glucose ≥11.1 mmol\u002FL after oral glucose tolerance test (OGTT) at screening; participants with FBG ≥6.1 mmol\u002FL but \\\u003C7.0 mmol\u002FL require OGTT;\n5. Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas\u002Fhypopneas ≥50%;\n6. Respiratory and neuromuscular diseases that could interfere with the results of the trial;\n7. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;\n8. Change of body weight \\>5% within 3 months prior to screening (selfreported);\n9. Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);\n10. Have received any medication for body weight loss and blood glucose lowering or medication that could lead to significant body weight increase, within 3 months prior to screening.","75 Years",{"count":202,"type":21},140,[204],"PHASE3","The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP",[29,207],"Obesity",[209,210,179,207,211],"XW003","Ecnoglutide","GLP-1","2026-04-09",{"date":214,"type":40},"2026-04-13",{"date":216,"type":40},"2026-03-02",{"date":218,"type":21},"2028-06-19",{"name":220,"class":141},"Hangzhou Sciwind Biosciences Co., Ltd.",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":111},"100622705","phase-3-a-study-of-xw003-in-obese-participants-with-obstructive-sleep-apnea-but-not-receive-positive-airway-pressure-therapy-100622705","NCT07387094","A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy","A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of XW003 Injections in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy","Inclusion Criteria:\n\n1. Body mass index (BMI) ≥ 28.0 kg\u002Fm2;\n2. The results of PSG meet the diagnosis criteria of OSA and with an AHI ≥15 at screening;\n3. Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP during the study;\n4. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n1. History of endocrine disorders which have significant impact on body weight;\n2. Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state\u002Fcoma;\n3. HbA1c ≥6.5% at screening;\n4. Fasting blood glucose ≥7.0 mmol\u002FL or 2-hour blood glucose ≥11.1 mmol\u002FL after oral glucose tolerance test (OGTT) at screening; participants with FBG ≥6.1 mmol\u002FL but \\\u003C7.0 mmol\u002FL require OGTT;\n5. Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas\u002Fhypopneas ≥50%;\n6. Respiratory and neuromuscular diseases that could interfere with the results of the trial;\n7. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;\n8. Change of body weight \\>5% within 3 months prior to screening (self-reported);\n9. Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);\n10. Have received any medication for body weight loss and blood glucose lowering or medication that could lead to significant body weight increase, within 3 months prior to screening.",{"count":202,"type":21},[204],"The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP",[29,207],[209,210,207,179,211],{"date":234,"type":40},"2026-04-14",{"date":236,"type":40},"2026-02-09",{"date":238,"type":21},"2027-12-16",{"name":220,"class":141},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":111},"100628351","mandibular-advancement-to-reduce-ventricular-load-and-improve-quality-of-life-in-heart-failure-100628351","NCT07460505","Mandibular Advancement to Reduce Ventricular Load and Improve Quality-of-life in Heart Failure","Mandibular Advancement to Reduce Ventricular Load and Improve Quality of Life in Heart Failure - a Randomized Controlled Trial","MARVEL-HF","Inclusion Criteria:\n\n* Age of at least 40 years old with the capacity to provide signed, written informed consent\n* Ischemic or non-ischemic cardiomyopathy with a left ventricular ejection fraction of 20% to 40% in the previous 6 months\n* Stable chronic HF with NYHA functional class I-III symptoms on maximally tolerated background therapy for at least 4 weeks\n* NT-proBNP \\>600 pg\u002FmL (for participants in sinus rhythm) or \\>900 pg\u002FmL (for participants in atrial fibrillation) in the previous 6 months (same as leading HF trials)\n* Agree to follow the study protocol\n* Able and willing to undergo a hospital-based overnight polysomnography\n\nExclusion Criteria:\n\n* Known OSA and already on regular treatment\n* Moderate or severe valvular stenosis or regurgitation\n* Severe hypoxemia on polysomnography ODI \\>60 or min SpO2 \\\u003C60%\n* Specific HF etiologies, including hypertrophic cardiomyopathy with left ventricular outflow tract obstruction; pericardial disease; infiltrative or inflammatory myocardial disease; valvular heart disease with severe aortic or primary mitral regurgitation, moderate or severe aortic stenosis, any mitral stenosis requiring surgical repair, or active endocarditis\n* Contraindications to MAD: less than six teeth in each arch; inability to advance the mandible and open the jaw widely.\n* Pre-existing temporomandibular joint problems, severe bruxism, and advanced periodontal disease (with mobility affecting MAD stability).\n* Patients who are planning to have restorations, dental prostheses or implants done in the next 12 months\n* Limited life expectancy (\\\u003C one year)\n* Cardiac or cerebrovascular events in the past 6 months, including myocardial infarction, unstable angina leading to hospitalization, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease\n* Current or planned mechanical circulatory support or heart transplantation Current or planned (within the next 6 months) hemodialysis or peritoneal dialysis","40 Years","99 Years",{"count":251,"type":21},328,[24],"Heart failure with reduced ejection fraction (HFrEF) is a serious condition that limits daily activities and often leads to hospital stays and early death. Many patients with HFrEF also have obstructive sleep apnea (OSA), a common but often undiagnosed condition where breathing repeatedly stops during sleep. This causes drops in oxygen, poor sleep, and stress on the heart, which can make heart failure worse.\n\nThe investigators are studying whether a device called a mandibular advancement device (MAD)-a mouthpiece worn during sleep that keeps the airway open-can help people with both HFrEF and moderate-to-severe OSA. This device is already approved to treat OSA and is often more comfortable and easier to use than a CPAP machine.\n\nIn our study, 328 patients in Singapore will be randomly assigned to use either the MAD or a sham device that looks the same but doesn't move the jaw. They will wear the device for 12 months. We will measure changes in a blood marker linked to heart failure severity, as well as exercise ability, blood pressure, sleep quality, and hospital visits.\n\nThe investigators hope this study will show that MAD is a simple and patient-friendly way to improve outcomes in people with heart failure.",[255,29],"Heart Failure",[257,179,258,259,260],"heart failure","clinical trial","biomarker","quality of life","2026-03-04",{"date":263,"type":40},"2026-03-10",{"date":265,"type":21},"2026-05-01",{"date":267,"type":21},"2031-04-01",{"name":269,"class":47},"National University Hospital, Singapore",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":277,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":4},"100625246","evaluation-of-a-wearable-pap-device-in-a-tethered-configuration-for-the-treatment-of-obstructive-sleep-apnoea-100625246","NCT07420140","Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnoea.","Evaluation of a Wearable PAP Device in a Tethered Configuration for the Treatment of Obstructive Sleep Apnea.","Inclusion Criteria: • Participants willing to give written informed consent\n\n* Participants who ≥ 18 years of age\n* Participants who can trial the APL mask system for up to 7 nights\n* Participants willing and able to complete the specified tasks\n* Participants being treated for Obstructive Sleep Apnea (OSA) for ≥ 3 months\\*\n* Participants on APAP therapy\\*\n* Participants currently using a Resmed AirFit N20 Medium mask\\*\n* Participants who are employees of Resmed\\^\n\n  * Only applicable to participants with OSA \\^ Only applicable to internal participants\n\nExclusion Criteria:\n\n* Participants using Bilevel flow generators\n\n  * Participants who are or may be pregnant\n  * Participants with a preexisting lung disease\u002F condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\\\u003C 2years) case of pneumonia or lung infection; lung injury.\n  * Participants (or participants bed partners) with active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin\u002Finfusion pumps).\n  * Participants (or participants bed partners) with metallic implants\u002Fobjects containing ferromagnetic material (i.e., aneurysm clips\u002Fflow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye)\n  * Participants who are currently enrolled in other clinical studies\n  * Participants believed to be unsuitable\\* for inclusion by the researcherꝉ",true,{"count":279,"type":21},15,[24],"Each participant will wear a wearable PAP device, tethered to a released PAP device for up to 7 nights. Objectives include collecting and evaluating participants feedback on seal, comfort and usability of the wearable PAP device.",[29],[179,28],"2026-02-12",{"date":286,"type":40},"2026-02-19",{"date":288,"type":21},"2026-03",{"date":136,"type":21},{"name":291,"class":141},"ResMed",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":300,"targetDuration":302,"studyType":175,"phases":4,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":111},"100620953","cognitive-function-in-obstructive-sleep-apnea-100620953","NCT07364318","Cognitive Function in Obstructive Sleep Apnea","Cognitive Function and Pathophysiological Mechanisms in Adults With Obstructive Sleep Apnea: Long-term Impact of Positive Airway Pressure Therapy","CUFM1DN","Inclusion Criteria:\n\n1. Informed consent.\n2. Age 18 - 65 years.\n3. Newly diagnosed OSA according to the criteria of the American Academy of Sleep Medicine Guidelines (overnight PSG with an AHI ≥5 events per hour, hypopneas defined by ≥ 10 seconds of airflow reduction accompanied by ≥ 3% desaturation or an arousal).\n4. Able to accomplish relevant tests and follow-up.\n\nExclusion Criteria:\n\n1. History of any chronic disease other than overweight and obesity.\n2. Severe psychiatric condition that could affect cognitive functions.\n3. Chronic use of medication or nicotine that may affect the study results.\n4. Prior neuropsychological assessment less than 6 months before the start of the research.\n5. Prior therapy for OSA (i.e., CPAP, upper airway surgery, or oral appliance).\n6. Motor or sensory deficits that would significantly complicate test administration.\n7. Patients who do not have Slovak as their native language actively used in daily communication.\n8. Considered by the study team as not suitable for enrollment based on clinical judgment.",{"count":301,"type":21},30,"12 Months","Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder and has been increasingly recognized as a contributor to cognitive decline and a potential risk factor for neurodegeneration. Previous studies have identified several associated comorbidities, including vascular dysfunction, metabolic alterations, and neuroinflammatory changes. However, the impact and underlying interplay of these pathophysiological mechanisms remain poorly understood due to the lack of integrated, multidimensional assessment. This prospective, observational, longitudinal cohort study aims to investigate cognition and OSA-related physiological and pathophysiological processes in 100 adults newly diagnosed with OSA, who have no history of chronic diseases (except for overweight and obesity) and are not receiving chronic medication. A subgroup of patients with moderate to severe OSA indicated for positive airway pressure (PAP) therapy will be followed to evaluate its long-term effects on cognitive function and related mechanisms. All participants will undergo polysomnography (PSG), comprehensive neuropsychological assessment, brain MRI with volumetric analysis, biomarker profiling from blood and saliva, and evaluation of endothelial function, baroreflex sensitivity, and gut microbiome composition at baseline and after 12 months. PAP adherence will be continuously monitored. The primary objective of this study is to characterize the profile of cognitive impairment associated with OSA. Secondary exploratory analyses will focus on factors contributing to neurocognitive dysfunction in OSA.",[29,305],"Cognitive Functions",[307,308,126,309,310,311,312],"Cognitive Function","Positive Airway Pressure Therapy","Neuroimaging","Biomarkers","Vascular Changes","Metabolic Changes","2026-01-15",{"date":315,"type":40},"2026-01-23",{"date":317,"type":40},"2024-11-01",{"date":319,"type":21},"2027-12-31",{"name":321,"class":47},"Comenius University",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":330,"enrollmentInfo":331,"targetDuration":333,"studyType":175,"phases":4,"briefSummary":334,"conditions":335,"keywords":338,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":111},"100617190","the-correlation-between-obstructive-sleep-apnea-related-nocturnal-hypoxemia-parameters-and-coronary-microvascular-dysfunction-a-prospective-cohort-study-sleep-cmd-100617190","NCT07315399","The Correlation Between Obstructive Sleep Apnea-Related Nocturnal Hypoxemia Parameters and Coronary Microvascular Dysfunction: A Prospective Cohort Study (SLEEP-CMD)","The Correlation Between Obstructive Sleep Apnea-Related Nocturnal Hypoxemia Parameters and Coronary Microvascular Dysfunction: A Prospective Cohort Study","SLEEP-CMD","Inclusion Criteria:\n\n1. Aged 18 to 80 years, of any gender.\n2. Scheduled for elective coronary angiography due to symptoms or evidence of myocardial ischemia.\n3. Agreed to and capable of completing overnight polysomnography (PSG) monitoring.\n4. Provided written informed consent and were willing and able to comply with baseline assessments and long-term follow-up.\n\nExclusion Criteria:\n\n1. Presence of coronary chronic total occlusion (CTO), history of coronary artery bypass grafting (CABG), severe valvular heart disease, dilated or hypertrophic cardiomyopathy, congenital heart disease, or heart failure (NYHA functional class III-IV).\n2. Sleep-disordered breathing with central sleep apnea (CSA) as the primary manifestation.\n3. Severe hepatic insufficiency (Child-Pugh class C) or renal failure (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n4. Pregnancy or lactation.\n5. Life expectancy of less than 2 years, or any other condition that the investigators considered unsuitable for participation in the study.","80 Years",{"count":332,"type":21},560,"36 Months","In a cohort of patients with suspected myocardial ischemia undergoing sleep studies, the objectives of this study were:\n\n1. To determine the association between various obstructive sleep apnea (OSA)-related nocturnal hypoxemia parameters and coronary microvascular dysfunction (CMD) in patients with suspected myocardial ischemia.\n2. To compare the predictive value of nocturnal hypoxemia parameters versus the traditional Apnea-Hypopnea Index (AHI) for coronary microvascular dysfunction.\n3. To evaluate the prognostic value of nocturnal hypoxemia parameters in predicting Major Adverse Cardiovascular Events (MACE) during the follow-up period.\n4. To explore the potential mediating roles of inflammatory and oxidative stress biomarkers in the relationship between nocturnal hypoxemia parameters and coronary microvascular dysfunction.",[29,336,337],"Coronary Microvascular Dysfunction (CMD)","Coronary Artery Disease (CAD)",[29,339,340],"Coronary Microvascular Dysfunction","Coronary Artery Disease","2025-12-18",{"date":343,"type":40},"2026-01-02",{"date":345,"type":21},"2025-12-30",{"date":347,"type":21},"2030-12-30",{"name":349,"class":47},"Beijing Anzhen Hospital",{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":179,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":111},"100599293","effect-of-weight-loss-from-esg-plus-lifestyle-changes-vs-lifestyle-changes-alone-in-sleep-apnea-patients-100599293","NCT07082608","Effect of Weight Loss From ESG Plus Lifestyle Changes vs. Lifestyle Changes Alone in Sleep Apnea Patients","Impact of Weight Loss From Endoscopic Sleeve Gastropathy (ESG) Plus Life Style Modification VS Life Style Modification Alone on Obstructive Sleep Apnea (OSA) Patients With Obesity - Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age \\> 18years.\n2. Obesity defined by ethnic specific BMI cut-offs through \\\u003C 40 kg\u002Fm².\n3. Diagnosed with moderate to severe OSA (Apnea-Hypopnea Index \\[AHI\\] ≥15).\n4. Stable weight (\\\u003C 5 kg change) within 3 months prior to screening\n5. Failure or inadequate weight loss with conservative methods:\n\n   1. lifestyle modification. and\u002For\n   2. anti-obesity medications\n6. No planned additional weight loss treatments (i.e. OTC supplements, pharmacotherapy or bariatric surgery) during the first 12-months following study treatment\n7. Willingness to comply with the study protocol, including in office follow-up visits and lifestyle modifications.\n8. Able to sign, understand, and sign a written Informed Consent Form to participate in the study.\n\nExclusion Criteria:\n\n1. Any previous or planned surgery for sleep apnea or major ear, nose, or throat surgery\n2. Significant craniofacial abnormalities that may affect breathing\n3. Diagnosis of central or mixed sleep apnea, or diagnosis of Cheyne-Stokes Respiration Obesity related\n4. History of disorder, other than OSA, associated with insomnia or excessive daytime sleepiness\n5. Obesity induced by other endocrinologic disorders, or monogenetic or syndromic forms of obesity\n6. Active device treatment of OSA other than continuous positive airway pressure therapy\n7. Requires the use of supplemental oxygen\n8. Previous bariatric surgery or any other gastrointestinal surgery where primary ESG will not be feasible.\n9. Active inflammatory bowel disease.\n10. Current or planned pregnancy or breastfeeding while participating in the study.\n11. Severe cardiopulmonary conditions contraindicating endoscopy.\n12. Uncontrolled psychiatric disorders.\n13. Eating disorder that will impact the ability of the subject to follow the lifestyle modification program\n14. History of substance abuse.\n15. Use of any over-the-counter or prescription medications that could affect the evaluation of excessive sleepiness\n16. Type 2 diabetics that has had a change within 3 months of the screening visit or planned change in medication for blood sugar management that has thee potential to impact weight loss (i.e. GLP-1 medications)",{"count":358,"type":21},74,[24],"Study Overview:\n\nObesity and Obstructive Sleep Apnea (OSA) are strongly linked. This study aims to understand whether a procedure called Endoscopic Sleeve Gastroplasty (ESG), along with lifestyle changes like healthy eating and regular exercise, can help improve symptoms of OSA in people with obesity.\n\nWhat is Obstructive Sleep Apnea (OSA)?\n\nOSA is a condition where your breathing repeatedly stops and starts during sleep. This happens when the airway becomes blocked-often due to extra fat around the neck and throat in people with obesity. These breathing interruptions can lead to poor sleep quality, daytime tiredness, mood issues, and long-term health risks like high blood pressure and heart problems.\n\nWhy Does Weight Matter?\n\nObesity is a major cause of OSA. Being overweight can cause:\n\nNarrowing of the airway\n\nMore inflammation in the body\n\nHormonal changes\n\nDifficulty breathing properly during sleep\n\nLosing weight can reduce these problems, ease OSA symptoms, and help improve sleep. Even a moderate amount of weight loss can make a big difference.\n\nHow Can People Lose Weight?\n\nMany people try to lose weight through:\n\nDiet changes\n\nExercise\n\nBehavioural changes like mindful eating\n\nThese methods can help, but some people find it hard to lose enough weight or keep it off. That's where medical procedures like ESG can help.\n\nWhat is ESG (Endoscopic Sleeve Gastroplasty)?\n\nESG is a non-surgical, minimally invasive weight-loss procedure. It works by reducing the size of your stomach using stitches (done through a tube inserted through your mouth-no cuts or incisions on the body). A smaller stomach means you feel full sooner and eat less.\n\nBenefits of ESG:\n\nHelps you lose weight (up to 20% of total body weight)\n\nLower risk of complications than traditional surgery\n\nShort recovery time\n\nNo hospital stay in most cases\n\nWhat Does the Research Say So Far?\n\nSome early studies have shown that ESG can help people lose a significant amount of weight and may also improve conditions related to obesity, such as OSA.\n\nOne study followed 99 people for a year after ESG. About 30% had OSA at the start. After the procedure, many reported improvement in their OSA symptoms.\n\nAnother study compared ESG with a more invasive surgery (laparoscopic sleeve gastrectomy or LSG). While LSG led to more weight loss, both groups showed similar improvements in OSA symptoms.\n\nThis shows that ESG may be a good option for improving OSA, but more research is needed to fully understand its benefits.\n\nWhy Is This Study Important?\n\nWith obesity and OSA becoming more common, it is important to find effective and safe treatments. This study will help us learn:\n\nHow much ESG can improve sleep and breathing in people with OSA\n\nWhether combining ESG with lifestyle changes is better than lifestyle changes alone\n\nHow ESG impacts other health problems linked to obesity\n\nWhat We Hope to Learn:\n\nWe believe that weight loss from ESG will:\n\nReduce the severity of OSA\n\nImprove sleep quality\n\nImprove overall health\n\nThe results of this study could help guide future treatment options for people with obesity and sleep apnea.",[29],"2025-12-13",{"date":364,"type":40},"2025-12-19",{"date":366,"type":40},"2025-08-19",{"date":368,"type":21},"2029-05-19",{"name":370,"class":47},"Asian Institute of Gastroenterology, India",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":111},"100612870","impact-of-atrial-fibrillation-ablation-on-sleep-parameters-100612870","NCT07259200","Impact of Atrial Fibrillation Ablation on Sleep Parameters.","Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)","AAHI","Inclusion Criteria (all must be met):\n\n* Diagnosis of atrial fibrillation (AFib) and scheduled catheter ablation.\n* Presence of at least one OSA risk factor: hypertension, male sex, BMI \\> 25, diabetes, excessive daytime sleepiness, snoring.\n\nExclusion Criteria:\n\n\\- Absence of predefined sleep apnea risk factors.",{"count":380,"type":21},100,"Assessment of Sleep Parameters Using Polygraphy in Patients with Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study: Afib Ablation and Hypopnea Index - The \"AAHI\" Study\n\nPrincipal Investigator:\n\nDr. Paweł Basiukiewicz, MD, PhD\n\nStudy Sponsor:\n\nPrimula Clinics sp. z o.o. Żyrardowska 31, 05-825 Grodzisk Mazowiecki, Poland NIP (Tax ID): 529 183 03 11\n\nDear Sir\u002FMadam,\n\nYou have been invited to participate in a scientific study aimed at assessing sleep parameters in patients with atrial fibrillation undergoing rhythm-control therapy. Please read this document carefully before deciding whether to take part in the study. If you have any questions, please contact the principal investigator.\n\nStudy Objective:\n\nTo assess sleep parameters using polygraphy in the course of treatment of patients with paroxysmal atrial fibrillation qualified for pulmonary vein isolation.\n\nStudy Procedures:\n\nThe study involves four polygraphic sleep studies (two before and two after atrial fibrillation ablation), each conducted at least 7 days apart.\n\nThe polygraphic studies will record the following parameters: pulse oximetry, heart rate, respiratory movements of the chest, and airflow through the anterior nares.\n\nThe study includes only patients undergoing atrial fibrillation ablation for the first time.\n\nRisks and Benefits:\n\nThe study is non-invasive and does not involve any direct health risks. Participation will not affect your treatment process, but it may provide valuable information about your health status.\n\nVoluntary Participation:\n\nParticipation in the study is entirely voluntary. You may withdraw from the study at any time without providing a reason and without any impact on your ongoing medical treatment.\n\nPersonal Data Protection (GDPR):\n\nIn accordance with Regulation (EU) 2016\u002F679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation - GDPR):\n\nThe data controller is Primula Clinics sp. z o.o.\n\nPersonal data will be processed solely for the purpose of conducting this study.\n\nData will be stored no longer than required by law or necessary for the research purposes.\n\nYou have the right to access your data, request its correction, deletion, restriction of processing, and to object to data processing.\n\nAll data will be protected against unauthorized access.",[383,29,384],"Atrial Fibrillation (AF)","Pulmonary Vein Isolation",[386,35,387,388,389,390,391,392,393],"atrial fibrillation","sleep apnoea","ablation","pulmonary vein isolation","pvi","snoring","choking","somnolence","2025-11-26",{"date":396,"type":40},"2025-12-02",{"date":398,"type":40},"2025-03-20",{"date":400,"type":21},"2026-02-28",{"name":402,"class":47},"Primula Clinics",{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":17,"minAge":411,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":420,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":111},"100595658","the-effect-of-systemic-nonsteroidal-anti-inflammatory-drugs-nsaids-vs-intraoperative-infiltration-of-steroids-in-tonsillar-bed-following-tonsillectomy-on-post-tonsillectomy-pain-100595658","NCT07035314","The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.","The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain: A Prospective Randomized Controlled Study.","NSAIDs","Inclusion Criteria:\n\n* Age: Between 4-10 years.\n* Indications of tonsillectomy such as:\n\n  * Recurrent acute attacks at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years.\n  * Chronic tonsillitis and hypertrophy of tonsils causing sleep apnea, difficulty in deglutition, interference in speech.\n* Tonsillectomy by cold dissection only.\n* American Society of Anesthesiologists (ASA) classification 1,2 (Normal Health, Mild systematic disease).\n\nExclusion Criteria:\n\n* Patients with age less than 4 and more than 10 years.\n* Indications of tonsillectomy other than chronic tonsillitis such as lymphoma.\n* Patients on chronic steroid therapy\n* Hemoglobin level less than 10 gm\u002FdL\n* Presence of acute infection in the upper respiratory tract, acute tonsillitis\n* American Society of Anesthesiologists (ASA) classification ASA 3,4 (Severe systematic disease such as uncontrolled Diabetes, cardiac disease, liver or kidney disease, life threating medical conditions)\n* Regular use of analgesics within a week of surgery.","4 Years","10 Years",{"count":414,"type":21},75,[24],"The aim of this study is to compare the efficacy of adding paracetamol to systemic non-steroidal anti-inflammatory drugs (NSAIDs) versus adding dexamethasone as local infiltration to paracetamol on post tonsillectomy pain control.",[418,419,29],"Tonsillitis Chronic","Tonsillitis Recurrent",[421,422,423,424,409],"tonsillitis","tonsillectomy","post tonsillectomy pain","Dexamethasone infiltration in tonsillar bed","2025-06-15",{"date":427,"type":40},"2025-06-25",{"date":429,"type":40},"2025-03-08",{"date":431,"type":21},"2025-08-01",{"name":433,"class":47},"Ain Shams University",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":4},"100589481","smartphone-application-home-based-exercises-in-obstructive-sleep-apnea-in-jeddah-100589481","NCT06954974","SMARTPHONE APPLICATION HOME-BASED EXERCISES IN OBSTRUCTIVE SLEEP APNEA IN JEDDAH","THE EFFECT OF SMARTPHONE APPLICATION HOME-BASED EXERCISES ON SLEEP QUALITY, FATIGUE, FUNCTIONAL CAPACITY, AND QUALITY OF LIFE IN OBSTRUCTIVE SLEEP APNEA IN JEDDAH","Inclusion Criteria:\n\n* Male and female patients with confirmed mild or moderate OSA\n* aged between 18 and 65 years\n* BMI ≤ 40 kg\u002Fm2\n* agreed to participatein the study were recruited.\n\nExclusion Criteria:\n\n* Pregnant patients\n* individuals younger than 18 or older than 65\n* those who refused to participate in the study\n* those with severe cardiopulmonary conditions such as chronic obstructive pulmonary disease or heart failure\n* those with head and neck anomalies\n* those with a BMI \\>40 kg\u002Fm² were excluded from the study.",{"count":442,"type":21},60,[24],"The study aim is to explore the effects of a home-based exercise training smartphone application on sleep quality, fatigue, functional capacity, and quality of life among obstructive sleep apnea (OSA) patients in Jeddah city, Saudi Arabia.",[29],"2025-04-28",{"date":448,"type":40},"2025-05-02",{"date":450,"type":21},"2025-05-25",{"date":452,"type":21},"2025-12-25",{"name":454,"class":47},"King Abdulaziz University",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":111},"100587467","phase-2-effects-of-eszopiclone-and-lemborexant-in-people-with-osa-with-a-low-arousal-threshold-who-have-difficulty-sleeping-100587467","NCT06928766","Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping","Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.","ELOSA","Inclusion Criteria:\n\n* Moderate or more difficulty \"staying or initiating asleep\" score on the Insomnia Severity Index questionnaire\n* Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index ≥ 10 events\u002Fhour\n* Low arousal respiratory threshold OSA endotype\n* BMI ≤35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Concomitant medications that interact or are contraindicated with eszopiclone, zopiclone, and Lemborexant\n* Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology\n* Current pregnancy or breast-feeding\n* Current or recent other medical conditions likely to affect results or safety",{"count":279,"type":21},[93],"Insomnia and obstructive sleep apnoea (OSA) are very common conditions, collectively estimated to affect 2 billion people globally, and share many of the same symptoms. It is also common for people to have both insomnia and sleep apnoea (COMISA). Indeed, 30 to 40% of patients with chronic insomnia also fulfil the diagnostic criteria for OSA. These people can be particularly challenging to treat with conventional therapy approaches.\n\nPeople get OSA for different reasons. One key cause is waking up too easily to minor airway narrowing episodes (a low arousal threshold).\n\nAccordingly, this study aims to increase the arousal threshold using a combination approach with a GABAergic and an orexin agent in appropriately selected individuals (i.e., the clinically relevant group of people with OSA with a low arousal threshold and difficulty maintain or initiating sleep). Sleep, breathing and next day performance will be compared across two monitored overnight sleep studies (placebo vs the study drugs).",[29],[468,469,470],"sleep disordered breathing","arousal","COMISA","2025-04-15",{"date":473,"type":40},"2025-04-18",{"date":475,"type":21},"2025-05-01",{"date":477,"type":21},"2027-06-30",{"name":479,"class":47},"Flinders University",{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":490,"studyType":175,"phases":4,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":111},"100568158","multidisciplinary-network-osa-code-obstructive-apnea-syndrome-digital-operative-model-in-public-health-for-an-early-diagnosis-and-therapy-monitoring-100568158","NCT06677580","Multidisciplinary Network OSA Code (Obstructive Apnea Syndrome): Digital Operative Model in Public Health for an Early Diagnosis and Therapy Monitoring","Multidisciplinary Network OSA Code (Obstructive Apnea Syndrome): Digital Operative Model in Public Health for an Early Diagnosis and Therapy Monitoring, a Monocentric Observational Prospective Study","DOMOSA","Inclusion Criteria:\n\n* patients with obstructive sleep apnea syndrome (Diagnosis according to American Academy of Sleep Society International Classification of Sleep Disorders, third edition (ICSD-3))\n* male and female\n* age \\> 18 years\n\nExclusion Criteria:\n\n* Unable of giving signed informed consent\n* Refuse to participate or withdrawal the consent",{"count":489,"type":21},500,"3 Years","Obstructive Sleep Apnea Syndrome (OSAS) is a sleep related breathing disorder with high epidemiological impact (9-38% of general population), more frequently reported in male gender and increasing with the age. Pathognomonic OSAS symptoms are snoring, excessive daytime sleepiness, sleep fragmentation, awakening during the night often for nocturia and morning headache. The repeated sleep fragmentation due to numerous awakenings (the patient is often unaware of this) can impair higher cognitive functions over the time and negatively impact the quality of life, If timely untreated.\n\nAmong the most frequently impaired cognitive functions detected in OSAS patients, there are attention, concentration, amnestic and executive domains. While these impairments are well documented in literature, the pathogenetic mechanisms underlying cognitive impairment are not yet defined. To date, the most widely accepted pathophysiological hypotheses are two: i) intermittent hypoxia (frequent brain awakenings); ii) sleep fragmentation. Moreover solid evidence report that, there is a strict correlation between OSAS and neurodegenerative diseases, such as Mild Cognitive Impairment (MCI) and Alzheimer's Dementia (AD). Indeed, OSAS might act as a trigger, accelerating the accumulation of harmful proteins in the brain, in particular beta-amyloid and tau protein.\n\nThe first-line treatment for OSAS is Continuous Positive Airway Pressure (CPAP). Of note is the effect of CPAP treatment on higher cognitive function in OSAS patients.\n\nNot all OSAS' patients, however, develop MCI\u002FAD over time. For this reason, to identify the OSA phenotype (both clinical and neuroimaging) at higher risk of phenoconversion represents an important challenge for neuropsychologists and neurologists.\n\nThe interest on OSAS is not purely scientific, but also economic, whit important repercussions on the intake and costs of hospital and home management of OSAS' patients.\n\nIn conclusion, OSAS is a syndrome needing great attention for several reasons: i) from a scientific point of view, it is important to identify for the risk of phenoconversion to highly disabling neurodegenerative diseases; ii) from an economic-welfare point of view, to reduce costs that still burden NHS.\n\nIn summary, the study may have an important impact on Public Health, considering the various aspects related to the taking care and management of OSAS' patients: 1) To know in details, the syndrome epidemiology and on this basis provide for the corresponding commitment of resources, suitable for implementing the support activities for both patients and families; 2) To have major information on the real prevalence of clinical signs and symptoms, to support and optimize the care efforts of physicians; 3) To assess the prognostic factors and outcomes of the treatment; 4) On the basis of the data collected in the platform, to have the possibility for support research.\n\nOSAS-platform could represent one of the most effective methods to improve scientific, clinical and therapeutical knowledge on OSAS-pathology.",[29],"2024-11-06",{"date":495,"type":40},"2024-11-07",{"date":497,"type":40},"2024-03-13",{"date":499,"type":21},"2029-12-01",{"name":501,"class":47},"IRCCS San Raffaele"]