[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obstructive-sleep-apnea-osa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obstructive-sleep-apnea-osa":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,48,76,107,151,183,203,226,262,286,318,346,366,393,419,449,471,491,512,534,555,578,601,626,651],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645057","phase-4-a-comparative-effectiveness-study-of-positive-airway-pressure-pap-therapy-dental-device-and-atomoxetine-oxybutynin-for-treatment-of-obstructive-sleep-apnea-in-adults-100645057",false,"NCT07679282","A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults","Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study","ADAPT-OSA","Inclusion Criteria:\n\n* Obstructive sleep apnea (AHI \\>\u002F= 5 per hour), diagnosed in the past 6 months\n* Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness\n* Willingness\u002Fability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin)\n* Health insurance of any type\n\nExclusion Criteria:\n\n* Prior treatment for OSA in past year\n* Central sleep apnea or narcolepsy\n* Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)\n* Heart failure with reduced ejection fraction of \\\u003C\u002F= 45%\n* Active coronary artery disease (angina or infarction within 3 months of enrollment)\n* Current untreated depression\n* Untreated narrow angle glaucoma\n* Untreated hypothyroidism\n* Clinically significant gastric retention\n* Clinically significant urinary retention\n* History of liver disease\n* Seizure disorder\n* Pregnant or nursing, or plans to become pregnant within the year\n* Concomitant medication use that is incompatible with atomoxetine or oxybutynin\n* Participation in another clinical study with an investigational product","ALL","18 Years",{"count":21,"type":22},2400,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.",[28],"Obstructive Sleep Apnea (OSA)",[30,31,32,33,34],"Sleep apnea treatments","Dental device for sleep","Positive airway pressure","Atomoxetine-oxybutynin","Comparative effectiveness","NOT_YET_RECRUITING","2026-06-29",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":22},"2026-09-01",{"date":43,"type":22},"2032-05-01",{"name":45,"class":46},"Sairam Parthasarathy","OTHER",4,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100644895","mandibular-advancement-device-mad-and-continuous-positive-airway-pressure-cpap-for-treatment-of-adult-patients-diagnosed-with-moderate-obstructive-sleep-apnea-100644895","NCT07677332","Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Adult Patients Diagnosed With Moderate Obstructive Sleep Apnea","Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Obstructive Sleep Apnea","Inclusion Criteria:\n\n* Objectively diagnosed with moderate OSA (AHI 15-29)\n* \\>\u002F= 18 years\n* BMI \\\u003C\u002F= 35 and neck circumference \\\u003C44cm\n* Fully sanitised at their own dentist (no periodontitis or caries requiring treatment. Periodontal bone loss \\\u003C50%)\n* \\>\u002F= 20 teeth.\n* Evenly distributed occlusal contacts\n\nExclusion Criteria:\n\n* Known craniofacial anomalies\n* General inflammatory joint diseases\n* Maximal protrusion of the mandible \\\u003C 6 mm\n* Severe deep bite\n* Anterior open bite\n* Severe attrition\n* Severe bruxism and involuntary mandibular movements\n* Conditions demanding treatment such as temporomandibular disorders (TMD)\n* Chronically pronounced nasal stenosis\n* Hypertrophic tonsils (tonsil size 3-4)\n* Prior blood clot in the brain or in the heart\n* Heart arrythmias\n* Other severe systemic diseases\n* Epilepsia\n* Allergies towards peanuts, soy or egg\n* Consumption of morphine or other sedatives which cannot be paused\n* Pregnant or breast-feeding women",{"count":56,"type":22},70,[58],"NA","Obstructive sleep apnea (OSA) is a frequent illness related to sleep and breathing with many symptoms and complications. The primary choices of treatment are continuous positive airway pressure (CPAP) and removable appliance for protruding the mandible when sleeping (MAD). Treatment with CPAP is superior to treatment with MAD but many patients don't tolerate CPAP why they seek treatment with MAD. In Denmark, treatment with MAD is not free of charge unlike treatment with CPAP and MAD is therefore not offered systematically to the patients. The same applies to adjustment, control and effect of the MAD treatment. MAD treatment has a positive effect on OSA in general but the effect varies due to differences in selection of patients and lack of specifying who performs and evaluates MAD treatment, the effect on sleep and possible side effects in muscles and the temporomandibular joint as well as the occlusion during treatment. It is therefore of great importance to investigate the effect of MAD treatment as well as short- and long-term side effects. The aim is therefore to compare the treatment effect of MAD and CPAP and how significant the investigation of the airways and the face is for the treatment effect and possible side effects. The project is a 4-year investigation and 70 adult patients diagnosed with moderate OSA are included. The results from the investigation will be of great importance for the choice of treatment and prognosis for the individual patient and socio-economic since the treatment of OSA could be tailored the individual patient and the treatment effect optimised.",[28],[62,63,64,65,66],"Obstructive sleep apnea","OSA","MAD","CPAP","Orthodontics",{"date":68,"type":39},"2026-06-30",{"date":70,"type":22},"2026-08",{"date":72,"type":22},"2029-08",{"name":74,"class":46},"University of Copenhagen",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":75},"100642932","exercise-interventions-in-obstructive-sleep-apnea-syndrome-100642932","NCT07634029","Exercise Interventions in Obstructive Sleep Apnea Syndrome","The Effect of Exercise Snacks and Aerobic Exercise on Circadian Rhythm and Functional Capacity in Individuals With Obstructive Sleep Apnea Syndrome","Inclusion Criteria:\n\n* Individuals diagnosed with OSAHS (AHI ≥ 15) confirmed by polysomnography, with moderate or severe disease, who have been receiving CPAP therapy for at least 3 months.\n* Adults aged 30-65 years.\n* No participation in any regular exercise program within the last 6 months.\n\nExclusion Criteria:\n\n* Individuals with OSAHS and a body mass index (BMI) \\> 35 kg\u002Fm²\n* Severe chronic pulmonary disease\n* Neurological or musculoskeletal disorders that prevent exercise\n* Unstable cardiovascular conditions\n* Unstable metabolic conditions\n* Severe psychiatric disorders such as bipolar disorder or schizophrenia\n* Pregnancy or breastfeeding\n* Individuals working night shifts or with schedules that may cause jet lag\n* Use of steroid or hormone therapy\n* Use of melatonin or sleep-regulating medications within the last 3 months\n* Presence of acute infection or inflammation","30 Years","65 Years",{"count":86,"type":22},39,[58],"Obstructive Sleep Apnea Syndrome (OSA) is a condition characterized by repeated pauses or reductions in breathing during sleep, which can negatively affect sleep quality, daytime functioning, and physical capacity. Although regular exercise is known to have beneficial effects in OSA, the effects of different exercise approaches on circadian rhythm and functional capacity have not been sufficiently investigated.The primary aim of this study is to compare the effects of exercise snacking and aerobic exercise on circadian rhythm and functional capacity in individuals with OSA, in comparison with a control group. The secondary aim is to evaluate the effects of these exercise interventions on peripheral muscle strength, fatigue level, body composition, quality of life, and physical activity level.Participants will be randomly assigned to three groups: an aerobic exercise group, an exercise snacking group, and a control group. While the exercise groups will follow their respective intervention programs, the control group will continue their routine treatment.This study aims to answer whether exercise snacking, which consists of short bouts of exercise distributed throughout the day, may be an alternative or complementary approach to traditional aerobic exercise in individuals with OSA. In addition, this study aims to be the first randomized controlled trial evaluating the effects of exercise snacking on circadian rhythm and functional capacity in individuals with OSA.",[28,90,91,92,93],"Exercise Snacks","Physical Activity","Circadian Rhythm","Sleep",[95,96,97,98],"Obstructive Sleep Apnea","exercise training","circadian rhythm","exercise snacks","2026-06-03",{"date":101,"type":39},"2026-06-08",{"date":41,"type":22},{"date":104,"type":22},"2028-02",{"name":106,"class":46},"Istanbul University - Cerrahpasa",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":84,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":150},"100643054","phase-2-dreamzz--dronabinol-and-acetazolamide-medication-for-sleep-apnea-zz-dose-confirmation-crossover-study-for-ihl-42x-in-subjects-with-obstructive-sleep-apnea-100643054","NCT07635563","DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.","Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea","DReAMzz","Inclusion Criteria\n\nParticipants must satisfy all the following criteria at screening unless otherwise stated:\n\n1. Aged ≥18 and ≤65 years of age at the time of consent.\n2. Two screening PSG findings confirmed on central over-read that both must meet the below criteria:\n\n   1. AHI4 ≥5\n   2. ≤25% central or mixed apneas out of total AHI\n   3. no Cheyne-Stokes respiration\n   4. total sleep time ≥ 4 hours in each PSG\n   5. \\\u003C 30 periodic leg movement disorder arousals per hour.\n3. A difference in AHI4 of ≤15 between screening PSG 1 and screening PSG 2.\n4. A PROMIS-SRI 8a score of \\>16.\n5. Intolerant or non-compliant to PAP, or has refused PAP after physician recommendation. Participants will be identified as intolerant or non-compliant to PAP devices by the following criteria (NB: OSA diagnosis must be entered in participant medical history):\n\n   1. Participants are regarded as PAP-non-compliant if they do not use PAP for ≥ 4 hours for at least 63 nights during consecutive 90-day period based on data collected from the PAP device (e.g., SD storage cards) and\u002For a cloud-based repository of PAP device data.\n   2. Participants are regarded as PAP-intolerant if they are former PAP users, i.e., a PAP device that they have not used for \\>90 days, have tried PAP and not continued to use it or refusal of PAP after prior positive sleep study or prior refusal of provider recommended sleep study due to unwillingness to consider PAP.\n\n   NB: Participants will have the benefits and risks of PAP explained at screening, including that PAP is standard of care for OSA. Participants also have the option to withdraw from the study at any time if he\u002Fshe elects to be treated with PAP or other alternative therapy such as an oral appliance or surgery.\n6. Must agree not to take any form of cannabis or cannabinoid with the exception of the IP, or any other illicit or recreational drug while participating in this study.\n7. A female participant of childbearing potential must agree to at least one approved highly effective method of contraception. Approved methods of contraception include the following:\n\n   1. Intra-uterine device in place for at least 3 months prior to Day 1 through to 10 days following the last dose of the study drug.\n   2. Stable hormonal contraceptive which includes oral, intravaginal, intrauterine, transdermal, injectable, or implantable methods of hormonal contraception for at least 3 months prior to Day 1 through to 10 days after the last dose of the study drug.\n\n      NB: Barrier method (condom or diaphragm) is not considered 'highly effective' for the purpose of this study and should be used in combination with one of the approved highly effective methods listed above.\n\n      A female will not be considered of childbearing potential if:\n   3. 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \\> 40 mIU\u002Fml.\n   4. Undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to Day 1.\n8. A male participant must agree to use at least 1 approved method of contraception (or as required by local regulations) while engaging in sexual activity from study Day -1 through EOS follow-up and\u002For up to 10 days following the last administration of the study drug. Male participants must not donate sperm during this same period. Approved methods of contraception include the following:\n\n   1. Barrier method (condom) from date of consent through to 10 days after the final dose of the study drug.\n   2. Surgical sterilization (vasectomy) at least 6 months prior to Day 1 with proof of azoospermia.\n9. Voluntarily written consent to participate in the study and be willing and able to participate in all scheduled visits, treatment plans, tests, and other study procedures according to the protocol.\n\nExclusion Criteria:\n\nParticipants will be excluded from the study if they satisfy any of the following criteria at screening, unless otherwise stated:\n\n1. Body mass index (BMI) \\>40 kg\u002Fm2 (men) and \\>42 kg\u002Fm2 (women).\n2. Diagnosed obesity hypoventilation syndrome or hypercapnia.\n3. PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.\n4. Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation devices. Devices must not be used for the duration of the study.\n5. Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug; or participants who are planning surgical treatment.\n6. Have commenced glucagon-like peptide-1 receptor agonist therapy within the last 6 months.\n7. Use of benzodiazepines, sedative-hypnotics or stimulants (Anatomical Therapeutic Chemical \\[ATC\\] N06B, N05C, N05BA, N03AE, and N01AF categories) to treat insomnia, OSA, and other sleep disorders, or other disorders that require the drug to be taken prior to sleep.\n8. Use of other prescription medications to treat insomnia.\n9. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.\n10. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.\n11. Known allergic or other severe reaction to cannabis products with previous use.\n12. Known allergic reaction to sesame oil.\n13. Known allergic reaction to acetazolamide.\n14. Pregnant or breastfeeding.\n15. Current illicit drug abuse (within the last 6 months prior to screening); \"abuse\" has some subsets that are objective and some that require investigator judgement; questions should be discussed with the medical monitor or with the sponsor\n\n    1. An objective subset includes consumption of substances that are \"illicit\", i.e., not legal per local laws\n    2. Investigator judgement is expected for legally marketed products ingested for other than the approved indication(s)\n    3. Participants who test positive to THC should be screen failed and can be considered for rescreening after a \\>6-week washout period. Participants can only be rescreened once. Positive test results for all other substances shall be reviewed by the investigator and participants shall only be screen failed if the investigator believes the use of the substance may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings.\n16. Severe depression, defined as a score of ≥30 on the Major Depression Inventory (MDI) questionnaire.\n17. Severe anxiety, defined as score of \\>15 on the General Anxiety Disorder-7 (GAD-7) questionnaire.\n18. Any of the following co-morbid conditions (NB: clarification on co-morbidities and inclusion\u002Fexclusion criteria may be discussed with the medical monitor and\u002For sponsor):\n\n    1. Severe psychiatric disorder that might be aggravated or exacerbated by dronabinol's potential to cause anxiety\u002Fnervousness, depersonalization, hallucination, etc.\n    2. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.\n    3. Cardiac dysfunction and\u002For its treatment that might augment dronabinol's potential to cause tachycardia or vasodilation.\n    4. Marked hepatic dysfunction as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × the upper limit of normal (ULN), that would reduce dronabinol metabolism.\n\n    i. One retest per participant is permitted at the discretion of the investigator; the participant may continue if BOTH repeat transaminase levels are within acceptable range (i.e., less than 3 × ULN).\n\n    e. Current or history of encephalopathy or cirrhosis Child-Pugh category B or C (see Appendix 8) since acetazolamide can increase blood ammonia levels precipitating a bout of hepatic encephalopathy.\n\n    f. Marked renal dysfunction that would reduce acetazolamide excretion, including eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2, as determined using the National Kidney Foundation calculator (https:\u002F\u002Fwww.kidney.org\u002Fprofessionals \u002Fkdoqi\u002Fgfr\\_calculator) and instructions in Appendix 9.\n\n    g. Hypokalemia (low blood potassium), hyponatremia (low blood sodium), hyperchloremic acidosis, and\u002For adrenal insufficiency that might be aggravated or exacerbated by acetazolamide's activity as a carbonic anhydrase inhibitor.\n19. Known CYP2C9 poor metabolizers (NB: this is based on medical history and does not need to be tested genetically).\n20. Other ongoing condition(s) that the investigator considers may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings; any consideration should be discussed with the medical monitor or with the sponsor (such as known alcohol abuse).\n21. Shift workers whose shift pattern has the potential to disrupt sleep patterns.\n22. Participation in any other interventional studies involving investigational or marketed products within 30 days or 5.5 half-lives, whichever is longer, prior to screening.",{"count":116,"type":22},120,[118],"PHASE2","The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea.\n\nThe primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days).\n\nThe study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.",[28],[63,62,122,65,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140],"Obstructive sleep apnoea","Cannabinoid","IHL-42X","Incannex","Dronabinol","THC","Aceazolamide","ACZ","AHI","PSG","Polysomnography","PAP","FOS-Q","FOSQ","PROMIS","PGI","ESS","REM","Phase II",{"date":142,"type":39},"2026-06-09",{"date":144,"type":22},"2026-06",{"date":146,"type":22},"2027-05",{"name":148,"class":149},"Incannex Healthcare Ltd","INDUSTRY",14,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":18,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":181,"locationsCount":75},"100638521","early-dental-risk-screening-for-pediatric-sleep-disordered-breathing-100638521","NCT07581938","Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing","Inclusion Criteria:\n\n* Ages 8-13 years old\n* American Society of Anesthesiologists Class I or II\n* Ability to read and understand the English or Spanish language\n* Ability to assent, with parent\u002Flegal guardian able to provide informed consent\n* Access to a smartphone capable of supporting the wearable monitoring application\n\nExclusion Criteria:\n\n* Diagnosis of a craniofacial syndrome or condition known to significantly alter craniofacial morphology\n* Prior diagnosis of sleep disordered breathing and\u002For obstructive sleep apnea\n* History of adenotonsillectomy\n* Prior or current orthodontic treatment\n* Prior orthognathic surgery",true,"8 Years","13 Years",{"count":161,"type":22},60,"OBSERVATIONAL","This is a prospective, cross-sectional observational study designed to evaluate the Pediatric Sleep Questionnaire (PSQ) as a screening tool for sleep-disordered breathing (SDB) risk in a pediatric dental setting. Children aged 8-13 years will be classified as low- or high-risk for SDB based on PSQ scores and compared using physiologic sleep parameters obtained from a wearable, FDA-cleared home sleep monitoring device, alongside psychosocial assessments and craniofacial measurements derived from lateral cephalometric radiographs. Findings will inform the feasibility and accuracy of incorporating validated SDB screening into routine pediatric dental care.",[165,166,28],"Early Risk Screening for Sleep Disordered Breathing in a Dental Setting","Sleep Disordered Breathing (SDB)",[168,169,28,166,170,171,172,173,174],"Pediatric Sleep Questionnaire","Apnea","Pediatric Dentistry","At-Home Sleep Study","Pediatric","Screening","Lateral Ceph","RECRUITING","2026-06-02",{"date":178,"type":39},"2026-06-04",{"date":144,"type":22},{"date":146,"type":22},{"name":182,"class":46},"University of North Carolina, Chapel Hill",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":75},"100638036","the-impact-of-volume-overload-on-obstructive-sleep-apnea-in-patients-with-congestive-heart-failure-100638036","NCT07601724","The Impact of Volume Overload on Obstructive Sleep Apnea in Patients With Congestive Heart Failure","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Hospitalized with decompensated heart failure and clinical evidence of fluid overload\n* Diagnosis of heart failure (reduced or preserved ejection fraction)\n* Clinically indicated for diuretic therapy\n* Able to undergo sleep apnea assessment using the WatchPAT device\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Known central sleep apnea as the predominant sleep-disordered breathing type\n* Current treatment with continuous positive airway pressure (CPAP)\n* Acute respiratory failure requiring mechanical ventilation\n* Conditions preventing proper use of the WatchPAT device (e.g., severe hand or finger injury)\n* Hemodynamic instability precluding participation\n* Pregnancy",{"count":190,"type":22},50,"The goal of this observational study is to learn how removing extra fluid from the body (diuresis) affects sleep apnea in adults hospitalized with heart failure.\n\nThe main questions it aims to answer are:\n\nDoes sleep apnea severity improve after fluid removal? Is the improvement in sleep apnea related to the amount of fluid removed? Do changes in neck size reflect changes in sleep apnea severity?\n\nParticipants admitted to the hospital with heart failure and fluid overload will take part in this study.\n\nParticipants will:\n\nUse a wearable sleep monitoring device (WatchPAT) on the first night of hospitalization Use the device again after fluid removal, when the treating cardiologist determines that the patient is no longer fluid overloaded Have their neck circumference measured before and after fluid removal Have their weight and fluid balance recorded during hospitalization Have routine blood tests and clinical assessments as part of standard care\n\nResearchers will compare each participant's results before and after fluid removal to see if sleep apnea improves and whether these changes are linked to fluid removal and changes in neck circumference.",[193,28],"Heart Failure","2026-05-19",{"date":196,"type":39},"2026-05-22",{"date":198,"type":39},"2026-01-01",{"date":200,"type":22},"2027-06",{"name":202,"class":46},"Itshak Amsalem",{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":157,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":75},"100587593","data-collection-study-to-review-novel-methods-for-diagnosing-obstructive-sleep-apnea-100587593","NCT06930404","Data Collection Study to Review Novel Methods for Diagnosing Obstructive Sleep Apnea","Innovation and Growth Network for Insightful Trends and Evaluation - Data Collection Study","Ignite","Inclusion Criteria:\n\nAdults aged \\>= 18 Ability to read and comprehend English\n\nExclusion Criteria:\n\n* Previous diagnosis of OSA\n* Respiratory diseases (such COPD, lung cancer, fibrosis of the lungs, lung injury)\n* Subjects who are or may be pregnant, breastfeeding or within 6 weeks postpartum (which may impact HRV temporarily)\n* Subjects with a pacemaker",{"count":212,"type":22},800,"This study will collect data on a range of signals such as facial scans, videos (including speaking, blinking and swallowing) and heart rate variability to assess whether any of these measures are useful for diagnosing obstructive sleep apnea",[28],[216,217],"diagnosis","screening","2026-05-17",{"date":194,"type":39},{"date":221,"type":39},"2025-09-15",{"date":223,"type":22},"2027-02-15",{"name":225,"class":149},"ResMed",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":234,"maxAge":19,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":75},"100638343","cpap-vs-high-flow-nasal-cannula-for-treating-sleep-apnea-in-children-100638343","NCT07600333","CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in Children","Continuous Positive Airway Pressure vs High Flow Nasal Cannula for the Treatment of OSA in Children","CHOSA","Inclusion Criteria:\n\n* Aged 2 to 18 years\n* Diagnosed with moderate to severe obstructive sleep apnea, defined as an obstructive apnea-hypopnea index (OAHI) ≥5 events\u002Fhour, confirmed by an in-laboratory polysomnography within the previous 6 months\n* Deemed to require Continuous Positive Airway Pressure (CPAP) therapy as part of usual clinical care\n* Ability of the participant and\u002For parent or legal guardian to provide informed consent (and assent when applicable)\n\nExclusion Criteria:\n\n* Predominant or pathological central sleep apnea (central apnea-hypopnea index ≥5 events\u002Fhour)\n* Chronic respiratory failure or medical conditions requiring ventilatory support with a set respiratory rate (e.g., neuromuscular disease requiring bilevel ventilation with a backup rate)\n* Hypoventilation requiring non-invasive ventilation with a set respiratory rate\n* History of pneumothorax or pneumomediastinum\n* Uncontrolled gastroesophageal reflux and\u002For recurrent vomiting\n* Uncontrolled oral secretions\n* Prior use of CPAP or High-Flow Nasal Cannula therapy for treatment of obstructive sleep apnea within the previous 12 months","2 Years",{"count":236,"type":22},258,[58],"This study is looking at two different treatments for obstructive sleep apnea (OSA) in children. OSA is a sleep condition where breathing repeatedly stops and starts during sleep, which can affect a child's health, behavior, learning, and quality of life.\n\nChildren with moderate-to-severe OSA who cannot be treated with surgery are often prescribed Continuous Positive Airway Pressure (CPAP). CPAP uses a mask worn during sleep to deliver pressurized air and keep the airway open. Although CPAP is effective, many children have difficulty using it regularly because it can feel uncomfortable or hard to tolerate.\n\nThis study compares CPAP with another treatment called High-Flow Nasal Cannula (HFNC). HFNC delivers warm, humidified air through soft nasal prongs and may be more comfortable and easier for children to use while still helping keep the airway open during sleep.\n\nChildren aged 2 to 18 years with moderate-to-severe OSA will be randomly assigned to use either CPAP or HFNC at home during sleep for 3 months. The study will measure how much each treatment is used, how well it improves sleep-related symptoms and quality of life, how comfortable it is for children, and how it affects caregivers.\n\nThe goal of this study is to find out whether HFNC is a comfortable and effective alternative to CPAP for treating obstructive sleep apnea in children.",[28],[241,242,243,244,245,65,246,247,248,249,250,251,252],"obstructive sleep apnea","pediatric obstructive sleep apnea","children","adolescents","continuous positive airway pressure","High Flow nasal cannula","HFNC","Sleep-disordered breathing","adherence","quality of life","home sleep therapy","randomized controlled trial","2026-05-14",{"date":255,"type":39},"2026-05-20",{"date":257,"type":22},"2026-06-01",{"date":259,"type":22},"2031-12",{"name":261,"class":46},"The Hospital for Sick Children",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":75},"100618527","effect-of-adenotonsillectomy-on-spinal-curve-magnitude-in-children-with-sleep-disordered-breathing-100618527","NCT07332780","Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing","A Randomized Controlled Study of Adenotonsillectomy on Spinal Curve Magnitude in Children With Mild Sleep-Disordered Breathing","Inclusion Criteria:\n\n1. Age between 6 and 15 years.\n2. Diagnosed with mild SDB, defined as: Obstructive Apnea-Hypopnea Index (OAHI) ≤5 events\u002Fhour on a laboratory-based PSG performed within the past 6 months, AND parental report of habitual obstructive breathing symptoms (e.g., snoring, mouth-breathing, witnessed apneas) occurring \\>3 nights per week on average.\n3. Tonsillar hypertrophy grade ≥2 (on a scale of 0-4) and deemed an appropriate candidate for AT upon ENT evaluation (i.e., no absolute contraindications such as submucous cleft palate).\n4. Has undergone radiographic screening for idiopathic scoliosis at the first clinic visit.\n5. Skeletally immature (Risser sign 0-3) with spinal Cobb angle \\\u003C 40 degrees.\n6. Informed consent\u002Fassent provided by the participant and guardian.\n\nExclusion Criteria:\n\n1. Unwillingness or inability to comply with study procedures.\n2. Plans to relocate outside the study area within 24 months.\n3. Previous tonsillectomy or adenoidectomy.\n4. Recurrent tonsillitis meeting guideline criteria for immediate AT.\n5. Severe OSA (OAHI \\>10 or as per clinician judgment) or significant hypoxemia requiring immediate CPAP therapy.\n6. Severe chronic conditions that could confound outcomes, including but not limited to:\n\n   * Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis.\n   * History of spine surgery or significant spinal injury.\n   * Spinal tumor.\n   * Leg length discrepancy \\>20 mm.\n   * Severe cardiopulmonary disease (e.g., cystic fibrosis, congenital heart disease).\n   * Significant cardiac arrhythmia noted on PSG.\n   * Bleeding disorders, Sickle Cell Disease.\n   * Uncontrolled diabetes, narcolepsy, or asthma.\n   * Known genetic, craniofacial, neurological, or psychiatric conditions likely to affect the airway or study participation.\n   * Severe obesity (BMI z-score ≥ 3).","6 Years","15 Years",{"count":272,"type":22},160,[58],"This study aims to determine the effect of adenotonsillectomy (AT) surgery on the progression of spinal curvature in children with mild sleep-disordered breathing (SDB) and concurrent scoliosis, as well as its potential role in preventing the de novo development of scoliosis in children with SDB.",[276,277,28],"Sleep-disordered Breathing (SDB)","Idiopathic Scoliosis",{"date":279,"type":39},"2026-05-15",{"date":281,"type":39},"2025-07-11",{"date":283,"type":22},"2028-07-31",{"name":285,"class":46},"Second Affiliated Hospital of Wenzhou Medical University",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":157,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":304,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":75},"100600934","ioa-preventing-occlusal-changes-with-mad-use-100600934","NCT07103941","IOA Preventing Occlusal Changes With MAD Use","Effectiveness of Interocclusal Aligner (IOA) on Preventing Occlusal Changes in Patients Treated With a Mandibular Advancement Device (MAD): A Preliminary Study","Inclusion Criteria:\n\n* adult participants (≥18 years)\n* diagnosed with SRBD and prescribed Mandibular Advancement Device (MAD) therapy\n* Participants will include patients with well restored natural dentition with all posterior teeth, excluding third molars, one missing premolar secondary to orthodontic treatment.\n\nExclusion Criteria:\n\n* pervious orthognathic surgery\n* anterior cross bite\n* posterior cross bite\n* existing open bite or implant supported restorations\n* tooth mobility\n* significant dental caries or periodontitis\n* severe bruxism\n* planned upcoming dental work including caps, crowns, implants, or braces\n* inadequate mandibular protrusion\n* severe micrognathia\n* large tori\n* significant claustrophobia\n* significant nasal obstruction\n* large oropharyngeal masses or large tonsils",{"count":294,"type":22},30,[58],"This study is evaluating two standard-of-care strategies used to prevent bite changes (occlusal changes) in patients treated with a Mandibular Advancement Device (MAD) for sleep-related breathing disorders such as obstructive sleep apnea (OSA). While MAD therapy is effective, it can lead to changes in how the teeth fit together, including the development of a posterior open bite.\n\nParticipants in this study will be randomly assigned to one of two standard-of-care approaches: using an interocclusal aligner each morning after removing the MAD, or performing daily jaw exercises. Both methods aim to reduce the risk of occlusal changes.\n\nThe study will follow participants over a 3-month period and includes dental evaluations, 3D oral scans, and short daily surveys. Findings from this research may help guide best practices for preserving occlusion during MAD therapy.",[298,299,28,300,301,302,303],"Sleep Related Breathing Disorder","Snoring","Open Bite","Occlusal Changes","Tooth Migration","Posterior Open Bite",[305,306,303,301,307,308,309,95],"Interocclusal Aligner","Mandibular advancement Device","Dental Changes","Protrusion","Sleep Appliance",{"date":311,"type":39},"2026-05-18",{"date":313,"type":39},"2025-11-17",{"date":315,"type":22},"2026-12-30",{"name":317,"class":46},"Isabel Moreno Hay",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":345},"100616588","high-flow-nasal-cannula-for-preventing-hypoxia-during-sedated-endoscopy-in-high-risk-obstructive-sleep-apnea-patients-100616588","NCT07307560","High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients","High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients: A Multicenter Randomized Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* STOP-Bang score ≥5.\n* Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).\n* The estimated duration of the procedure does not exceed 45 minutes.\n* Patients have signed the informed consent form.\n\nExclusion Criteria:\n\n* Coagulation disorders or bleeding tendency (e.g., oral\u002Fnasal bleeding risk, mucosal injury, space-occupying obstructions).\n* Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature \\>37.5°C).\n* Chronic obstructive pulmonary disease or other acute\u002Fchronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.\n* Severe organ dysfunction, including: Cardiac insufficiency (\\\u003C4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.\n* Confirmed pregnancy or current breastfeeding.\n* Known allergy to sedatives (e.g., propofol) or medical adhesives.\n* Multiple traumatic injuries.\n* Current participation in another clinical trial.\n* Other conditions deemed unsuitable by the investigator",{"count":326,"type":22},600,[58],"Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.",[330,331,332,28],"Hypoxia","Esophageal Cancer","Gastric Cancer (Diagnosis)",[334,330,28,335],"Sedation","Gastrointestinal Endoscopy","2026-05-01",{"date":338,"type":39},"2026-05-04",{"date":340,"type":39},"2025-12-21",{"date":342,"type":22},"2026-12-01",{"name":344,"class":46},"Zhejiang University",3,{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":4},"100636332","phase-4-informing-patients-with-oximetry-data-to-improve-mad-engagement-100636332","NCT07564310","INFORMing Patients With Oximetry Data to Improve MAD Engagement","INFORMing Patients With Oximetry Data to Improve Mandibular Advancment Device (MAD) Engagement","INFORM","Inclusion Criteria:\n\n* Participants willing to give written informed consent; Participants who can read and comprehend English; ≥ 18 years of age; Participants who have mild-to-moderate OSA, or severe OSA where CPAP has failed, is not tolerated, or is refused; Participants who can participate in the study for up to 4 weeks; Participants who own and can use a smartphone that is compatible with the study app; Participants who have the cognitive ability to follow the study instructions and procedures; Participants who have undergone a panoramic X-ray and are deemed suitable for MRD use\n\nExclusion Criteria:\n\n* Participants who are pregnant or may be pregnant; Participants who have a major psychiatric disorder that, in the investigator's opinion, could interfere with participation; Participants who have severe insomnia, for example usually sleeping less than about four hours per night; Participants believed to be unsuitable for the study for safety or other medical reasons by the investigator; Participants who are currently enrolled in another medical clinical study; Participants who have central sleep apnoea; Participants who have severe respiratory disorders other than OSA; Participants who have dental contraindications to using an oral appliance, such as loose teeth or advanced periodontal (gum) disease; Participants who have a completely edentulous lower arch (no lower teeth) unless a complete denture that is mechanically retained (for example, by implants) is present; Participants who have a completely edentulous upper arch (no upper teeth) unless a complete upper denture is present; Participants who have short teeth and\u002For insufficient undercuts to retain the device securely",{"count":116,"type":22},[25],"Obstructive sleep apnea (OSA) is common and associated with impaired daytime functioning, reduced quality of life and increased cardiovascular, metabolic and perioperative risk.\n\nMandibular advancement devices (MADs) are a guideline-supported, non-invasive alternative to CPAP for patients with mild to moderate OSA and for those with severe OSA who refuse or cannot tolerate CPAP.\n\nMAD therapy relies heavily on patient engagement and sustained use over time. However, in usual care, patients typically have limited access to objective information about their treatment response. Titration is often based on intermittent assessments and subjective symptom reporting, with little real-time feedback to patients on treatment effectiveness.\n\nThis lack of visibility may limit patient understanding of their condition, reduce engagement with therapy, and delay optimisation of treatment.\n\nAdvances in nocturnal oximetry now enable multi-night, home-based assessment of oxygen desaturation and related metrics. The myNarval CC solution provides patients, alongside clinicians, with access to objective oximetry data during MAD therapy. By increasing patient awareness of treatment response, this approach has the potential to enhance engagement, support adherence, and improve the overall treatment experience.\n\nThe purpose of this study is to evaluate whether access to oximetry data through the myNarval CC solution improves patient-reported experience measures (PREMs) compared with standard care in patients treated with MADs for OSA.",[28],[359],"mandibular advancement device MAD","2026-04-26",{"date":338,"type":39},{"date":257,"type":22},{"date":364,"type":22},"2027-05-01",{"name":225,"class":149},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":374,"maxAge":84,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":389,"leadSponsor":391,"locationsCount":4},"100635726","effective-of-early-treatment-of-insomnia-on-the-adherence-of-cpap-100635726","NCT07556432","Effective of Early Treatment of Insomnia on the Adherence of CPAP","Comorbid Insomnia and Sleep Apnea (COMISA): Can Early Treatment of Insomnia Improve Adherence to CPAP Therapy?","CoPAP","Inclusion criteria:\n\n1. 45-65 years of age\n2. Diagnosis of OSAS by respiratory polygraphy or polysomnography with an apnea-hypopnea index (AHI) ≥20 when scored by PSG or ≥15 when scored by PG30 with a prescription for CPAP therapy\n3. Diagnosis of chronic insomnia according to the International Classification of Sleep Disorders (ICSD 3-TR).31\n4. Ability to communicate in French\n5. Ability to provide informed consent\n6. Accept to receive information about incidental findings\n7. Ownership of a smartphone running at least Android 9 (API version 28+) or iOS 12.2+.\n\nExclusion criteria:\n\n1. Current treatment for OSAS\n2. Current or past treatment for chronic insomnia (CBT-I)\n3. Severe restless legs syndrome\n4. REM sleep behaviour disorder\n5. Neurological diseases (stroke, Parkinson's disease, etc.)\n6. Severe hypertension (≥180 mmHg systolic or requiring ≥3 antihypertensive medications)\n7. Respiratory failure (oxygen saturation during wakefulness \\\u003C90%)\n8. Severe heart failure (NYHA class III-IV)\n9. High-risk alcohol consumption (≥14 units\u002Fweek)\n10. Known pregnancy\n11. Epilepsy or history of epileptic seizures (ICD-11: 8A6; ICD-10: G40)\n12. Known bipolar disorder of any type (ICD-11: 6A60, 6A61, 6A6Y, 6A6Z; ICD-10: F31)\n13. Known Acute and transient psychotic disorder (ICD-11: 6A23; ICD-10: F23)\n14. Known Active suicidal ideation\n15. Known or suspected severe parasomnias incompatible with programme use (e.g., sleepwalking:\n16. Known Severe cardiovascular disease that may contraindicate unsupervised CBT-I strategies (e.g., unstable arrhythmias, angina pectoris)\n17. Any medical or psychiatric condition that, in the investigator's judgment, would contraindicate the use of the CE-marked HelloBetter Insomnie digital device or participation in CBT-I","45 Years",{"count":116,"type":22},[58],"This study includes patients suffering from both sleep apnea and insomnia. All participants receive treatment with CPAP. Half of the participants additionally receive a digital program to treat insomnia, initiated at the same time as CPAP. The other half follows usual care and will be able to access the program after 6 months. The aim is to determine whether treating insomnia earlier improves CPAP use and overall health.",[28,379],"Insomnia Chronic",[62,63,65,381,382,383,384],"COMISA","cognitve behavorial therapy for insomnia","cognitive health","cardiovascular health","2026-04-22",{"date":387,"type":39},"2026-04-29",{"date":257,"type":22},{"date":390,"type":22},"2028-12-31",{"name":392,"class":46},"Centre Hospitalier Universitaire Vaudois",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":401,"enrollmentInfo":402,"targetDuration":404,"studyType":162,"phases":4,"briefSummary":405,"conditions":406,"keywords":407,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":417,"locationsCount":75},"100635572","ios-parameters-and-pap-titration-pressure-in-obstructive-sleep-apnea-100635572","NCT07554430","IOS Parameters and PAP Titration Pressure in Obstructive Sleep Apnea","Impulse Oscillometry for Prediction of PAP Titration Pressure in Obstructive Sleep Apnea (IOS-PAP Study)","IOS-PAP","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Diagnosed with obstructive sleep apnea (OSA) by overnight polysomnography (PSG)\n* Apnea-hypopnea index (AHI) ≥ 15\n* Undergoing positive airway pressure (PAP) titration (CPAP or BPAP)\n* Able to perform impulse oscillometry (IOS) test\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Central sleep apnea\n* Neuromuscular disease or restrictive lung disease\n* Recent upper airway infection (\\\u003C 2 weeks)\n* Incomplete PSG or IOS data\n* Inability to cooperate with testing procedures","80 Years",{"count":403,"type":22},92,"4 Weeks","This prospective observational study aims to investigate whether impulse oscillometry (IOS)-a non-invasive lung function test-can help predict the specific pressure settings needed for positive airway pressure (PAP) therapy in patients with obstructive sleep apnea (OSA).\n\nCurrently, finding the optimal therapeutic pressure for OSA patients typically requires a titration process during sleep. This study explores if IOS parameters, which measure airway resistance and elasticity through small pressure oscillations during normal breathing, correlate with the final titration pressures (CPAP, EPAP, IPAP, and ΔP) determined by polysomnography.\n\nAdult patients diagnosed with moderate-to-severe OSA (Apnea-Hypopnea Index ≥ 15) will undergo standard diagnostic sleep testing followed by IOS testing using the Vyaire Vyntus BodyBox® system. The researchers will evaluate whether these respiratory measurements can accurately predict required airway pressures and if they can help clinicians distinguish between patients who need Continuous Positive Airway Pressure (CPAP) versus Bilevel Positive Airway Pressure (BPAP) therapy.",[28],[241,408,409,410],"positive airway pressure","cpap","bpap","2026-04-21",{"date":413,"type":39},"2026-04-28",{"date":336,"type":22},{"date":416,"type":22},"2027-01-02",{"name":418,"class":46},"Mustafa Kemal University",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":269,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":428,"briefSummary":429,"conditions":430,"keywords":432,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":448},"100614505","phase-4-endotype-directed-treatment-for-osa-in-down-syndrome-100614505","NCT07280468","Endotype DIrected Treatment for OSA in Down Syndrome","EDIT OSA","Inclusion Criteria:\n\n1. Age 6 years or older\n2. Down syndrome diagnosis\n3. Any gender or ethnicity\n4. Adults without a legally authorized representative must have a caregiver\u002Fsupport person that can co-sign consent and complete study questionnaires.\n\nExclusion Criteria:\n\n1. Currently using and adherent to PAP therapy (\\>4 hours per night for 70% of nights in the past 30 days based on device download or parent\u002Fcaregiver report)\n2. MAO inhibitor use\n3. Urinary retention\n4. Seizure disorder\n5. Untreated or inadequately treated hypothyroidism\n6. Significant traumatic brain injury\n7. Not cleared to participate in the study by their cardiologist for individuals with congenital heart disease requiring follow up with cardiology at least once in the past year\n8. History of current, untreated depression\n9. History of liver disease (not including metabolic dysfunction-associated steatotic liver disease)\n10. 3+ or greater tonsillar hypertrophy (for children only, no restriction for adults)",{"count":427,"type":22},200,[25],"Down syndrome is the most common genetic cause of intellectual disability. People with Down syndrome often have obstructive sleep apnea (OSA), a condition where people have difficulties with breathing while asleep. OSA can lead to poor sleep, worse quality of life, behavior problems and more difficulties with thinking (\"cognitive impairment\"). Current treatments for OSA in people with Down syndrome are not very effective or require surgery. The combination of 2 medications, atomoxetine and oxybutynin (\"ato-oxy\") is a promising treatment for OSA in people with Down syndrome, but ato-oxy does not work for everyone with Down syndrome. Similarly, oxygen is effective for OSA in some people, but does not work for everyone. This study will evaluate the use a precision medicine approach to increase the effectiveness of OSA treatment in people with Down syndrome. The study will compare two groups. In the first group, everyone will be treated with ato-oxy. In the second group, a precision medicine approach will be used to assign participants to either ato-oxy or oxygen therapy, based on the specific reasons they have OSA.\n\nThe research team will enroll 200 children (age 6-17 years old) and adults with Down syndrome and OSA from five sites across the country. Half of participants will randomly receive ato-oxy while the other will receive either oxygen or ato-oxy dependent upon which treatment would be expected to work better for them. The research team will measure OSA severity, quality of life, behavior and cognition at the start of the study and after 12 months of treatment for every participant. The study will also track any treatment side effects for each treatment group.",[28,431],"Down Syndrome",[433,241,434,435,436,437,438],"Down syndrome","ato-oxy","precision medicine","oxygen","atomoxetine","oxybutynin","2026-04-01",{"date":441,"type":39},"2026-04-07",{"date":443,"type":39},"2026-03-14",{"date":445,"type":22},"2030-01",{"name":447,"class":46},"University of Arizona",5,{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":458,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":75},"100631526","phase-3-evaluate-the-efficacy-and-safety-of-gzr18-injection-in-obese-subjects-with-obstructive-sleep-apnea-receiving-positive-airway-pressure-pap-therapy-100631526","NCT07501832","Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy","A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy","Inclusion Criteria:\n\n1. Subject is aged ≥18 years at the time of signing the informed consent form.\n2. Body mass index (BMI) is ≥28 kg\u002Fm² at both screening and randomization.\n3. Subject has a documented history of at least one unsuccessful attempt at weight loss through dietary control prior to screening, and has had \\\u003C5% change in body weight during the 12 weeks prior to screening (see Appendix 2 for the weight change calculation formula).\n4. Subject has been diagnosed with obstructive sleep apnea (OSA) according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria prior to screening, and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events\u002Fhour on polysomnography (PSG) at screening. (See Appendix 3 for ICSD-3 diagnostic criteria for adult OSA.)\n5. Subject has been receiving continuous positive airway pressure (PAP) therapy for at least 12 consecutive weeks prior to screening and intends to continue PAP therapy throughout the study period.\n6. Subjects of childbearing potential must agree to remain abstinent or use highly effective contraception from the time of signing informed consent until 8 weeks after the last dose of investigational product, and must not donate sperm or oocytes during this period. Female subjects of childbearing potential must not be lactating and must have a negative pregnancy test at both screening and randomization.\n7. The subject fully understands the purpose, nature, methods, and potential adverse reactions of the trial; is able to communicate effectively with the investigator; comprehends and agrees to comply with all study requirements; and voluntarily signs the informed consent form to participate in this study.\n\n   \\-\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or any of their excipients, or presence of a contraindication to GLP-1 RA use.\n2. History of any type of diabetes mellitus (history of gestational diabetes is permitted).\n3. Has undergone or plans to undergo during the study period surgical or device-based obesity treatment (exceptions: acupuncture, liposuction, or abdominal fat removal performed \\>1 year prior to screening; prior device-based obesity treatment is acceptable if the device was removed \\>1 year before screening).\n4. Secondary obesity due to disease, medication, or other causes (e.g., Cushing's syndrome, Prader-Willi syndrome, monogenic obesity, or obesity secondary to hypothalamic\u002Fpituitary injury).\n5. Clinically significant gastric emptying disorders at screening (e.g., gastroparesis or gastric outlet obstruction); or long-term use (≥4 consecutive weeks) of medications affecting gastrointestinal motility within 6 months prior to screening.\n6. History of acute or chronic pancreatitis or pancreatic injury prior to screening.\n7. History of symptomatic gallbladder disease at screening (post-cholecystectomy status is permitted); or presence at screening of cholelithiasis conferring high risk for acute biliary pancreatitis.\n8. Clinical or subclinical thyrotoxicosis at screening, regardless of treatment status.\n9. Inadequately controlled blood pressure at screening or randomization: systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg (concurrent antihypertensive therapy is permitted).\n10. History within 6 months prior to screening of: decompensated heart failure (NYHA Class III-IV), unstable angina, myocardial infarction, ischemic or hemorrhagic stroke (lacunar infarcts excluded), transient ischemic attack; or invasive cardiovascular procedures\u002Ftherapies (e.g., valve replacement, CABG, PCI). (Diagnostic coronary angiography without intervention is permitted.)\n11. Positive response on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screening Version to Question 4 or 5 of the \"Suicidal Ideation\" section, or any question in the \"Suicidal Behavior\" section, with the event occurring within 4 weeks prior to screening; or investigator assessment of significant suicide risk during the study.\n12. History of moderate-to-severe depression; or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.\n13. Any uncontrolled acute or chronic hepatitis other than metabolic dysfunction-associated fatty liver disease (MAFLD).\n14. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) type 2A or 2B.\n15. History of malignancy within 5 years prior to screening (exceptions: definitively cured in situ carcinomas, e.g., basal\u002Fsquamous cell skin cancer, cervical in situ carcinoma, or prostate in situ carcinoma).",{"count":457,"type":22},140,[459],"PHASE3","The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of GZR18 injection in Chinese adult obese patients with moderate-to-severe obstructive sleep apnea (OSA) who are currently using positive airway pressure (PAP) therapy. This study will assess the impact of GZR18 on OSA-related symptoms, respiratory parameters, and quality of life compared to placebo.",[28],"2026-03-30",{"date":464,"type":39},"2026-04-03",{"date":466,"type":22},"2026-03-27",{"date":468,"type":22},"2028-09-28",{"name":470,"class":149},"Gan & Lee Pharmaceuticals.",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":482,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":75},"100630852","phase-3-evaluate-the-efficacy-and-safety-of-gzr18-injection-in-obese-subjects-with-obstructive-sleep-apnea-not-treated-with-positive-airway-pressure-pap-therapy-100630852","NCT07493057","Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy","A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea（OSA） Not Treated With Positive Airway Pressure（PAP）","Inclusion Criteria:\n\n1. Subject is aged ≥18 years at the time of signing the informed consent form.\n2. Body mass index (BMI) is ≥28 kg\u002Fm² at both screening and randomization.\n3. Subject has a documented history of at least one unsuccessful attempt at weight loss through dietary control prior to screening, and has had \\\u003C5% change in body weight during the 12 weeks prior to screening.\n4. Subject has been diagnosed with obstructive sleep apnea (OSA) , and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events\u002Fhour on polysomnography (PSG) at screening.\n5. Unable or unwilling to receive PAP therapy before screening, and not planning to initiate PAP therapy during the study period.\n\n   \\-\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or any of their excipients, or presence of a contraindication to GLP-1 RA use.\n2. History of any type of diabetes mellitus (history of gestational diabetes is permitted).\n3. Has undergone or plans to undergo during the study period surgical or device-based obesity treatment (exceptions: acupuncture, liposuction, or abdominal fat removal performed \\>1 year prior to screening; prior device-based obesity treatment is acceptable if the device was removed \\>1 year before screening).\n4. Secondary obesity due to disease, medication, or other causes (e.g., Cushing's syndrome, Prader-Willi syndrome, monogenic obesity, or obesity secondary to hypothalamic\u002Fpituitary injury).\n5. Clinically significant gastric emptying disorders at screening (e.g., gastroparesis or gastric outlet obstruction); or long-term use (≥4 consecutive weeks) of medications affecting gastrointestinal motility within 6 months prior to screening.\n6. History of acute or chronic pancreatitis or pancreatic injury prior to screening.\n7. History of symptomatic gallbladder disease at screening (post-cholecystectomy status is permitted); or presence at screening of cholelithiasis conferring high risk for acute biliary pancreatitis.\n8. Clinical or subclinical thyrotoxicosis at screening, regardless of treatment status.\n9. Inadequately controlled blood pressure at screening or randomization: systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg (concurrent antihypertensive therapy is permitted).\n10. History within 6 months prior to screening of: decompensated heart failure (NYHA Class III-IV), unstable angina, myocardial infarction, ischemic or hemorrhagic stroke (lacunar infarcts excluded), transient ischemic attack; or invasive cardiovascular procedures\u002Ftherapies (e.g., valve replacement, CABG, PCI). (Diagnostic coronary angiography without intervention is permitted.)\n11. Positive response on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screening Version to Question 4 or 5 of the \"Suicidal Ideation\" section, or any question in the \"Suicidal Behavior\" section, with the event occurring within 4 weeks prior to screening; or investigator assessment of significant suicide risk during the study.\n12. History of moderate-to-severe depression; or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.\n13. Any uncontrolled acute or chronic hepatitis other than metabolic dysfunction-associated fatty liver disease (MAFLD).\n14. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) type 2A or 2B.\n15. History of malignancy within 5 years prior to screening (exceptions: definitively cured in situ carcinomas, e.g., basal\u002Fsquamous cell skin cancer, cervical in situ carcinoma, or prostate in situ carcinoma).",{"count":457,"type":22},[459],"This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.",[28],[483,241],"obesity","2026-03-24",{"date":466,"type":39},{"date":487,"type":22},"2026-04-27",{"date":489,"type":22},"2027-11-14",{"name":470,"class":149},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":448},"100601653","inspire-uas-high-apnea-hypopnea-index-ahihigh-body-mass-index-bmi-post-approval-study-100601653","NCT07113288","Inspire UAS High Apnea Hypopnea Index (AHI)\u002FHigh Body Mass Index (BMI) Post-Approval Study","Inspire UAS High AHI\u002FHigh BMI Post-Approval Study","AHIBMI PAS","Inclusion Criteria:\n\n1. Subject is at least 18 years of age;\n2. Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32\\\u003CBMI≤40 kg\u002Fm2;\n3. Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI \\> 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (\\> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).\n4. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;\n5. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the study;\n6. Subject is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Subject has a combination of central + mixed apneas \\> 25% of the total apnea-hypopnea index (AHI) based on a recent sleep study (within 12 months);\n2. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;\n3. Subject has any condition or procedure that has compromised neurological control of the upper airway;\n4. Subject is unable or does not have the necessary assistance to operate the patient remote;\n5. Subject is pregnant or plans to become pregnant;\n6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;\n7. Subject has a terminal illness with life expectancy \\\u003C 12 months;\n8. Any other reason the investigator deems the subject is unfit for participation in the study.",{"count":56,"type":22},"The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.",[28],[95,63,503,130],"Inspire","2026-03-23",{"date":466,"type":39},{"date":507,"type":39},"2025-07-31",{"date":509,"type":22},"2032-01-01",{"name":511,"class":149},"Inspire Medical Systems, Inc.",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":521,"briefSummary":522,"conditions":523,"keywords":524,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":530,"leadSponsor":532,"locationsCount":4},"100630947","personalised-active-self-management-of-sleep-apnea-program-100630947","NCT07494292","Personalised Active Self-management of Sleep Apnea Program","A Personalised Active Self-management of Sleep Apnea Program (PASS) to Improve Positive Airway Pressure Treatment Uptake and Adherence: A Pilot Randomized Controlled Trial","PASS","Inclusion Criteria:\n\n* Aged 18 years and above\n* Newly diagnosed with OSA (diagnosis made within the past year)\n* Newly started or not yet started Positive Airway Pressure (PAP) treatment, with a treatment duration of less than 6 months\n* Physically inactive (self-reported moderate physical activity per week of \\\u003C150 minutes)\n* Overweight (BMI≥23 kg\u002Fm2)\n* Mentally, cognitively, and physically fit to join the trial as determined by the doctor in charge and responsible clinical investigators\n* Able to speak, read, and write Chinese\n* Willing to complete the questionnaires and assessments\n* Has a smartphone\n\nExclusion Criteria:\n\n* Clinically significant psychiatric disorder\n* Use of prescription drugs or clinically significant drugs affecting sleep.",{"count":161,"type":22},[58],"This study is to assess the feasibility and acceptability of the PASS in patients with OSA. Second, the study examines its effectiveness in improving PAP uptake and adherence, self-efficacy in self-care, changes in health-related habits, and health outcomes. We also assess the facilitators and barriers to implementing the PASS.\n\nThis is a two-group pilot randomized controlled trial (n=60) with a 4-month follow-up. Subjects assigned to the intervention group will receive a 4-month Personalized and Adaptive Sleep Support (PASS) program, a digital platform-based intervention. The 4-month program incorporates: i) a 20-minute brief motivational interviewing session; ii) a digital platform where users can view personalized OSA health-related videos and information, track their adherence to prescribed treatments, log their daily activities and dietary intake, and set personal health goals; and iii) continuous personalized chat-based messaging and phone call support. Participants in the control group will receive a 4-month general hygiene program, including (i) a 20-minute session, (ii) messaging, and (iii) phone call support.\n\nThe feasibility and acceptability of the PASS will be evaluated via semi-structured interviews at the 4-month follow-up. Self-administered questionnaires will be used at baseline, 2 months, and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline and at the 2- and 4-month follow-ups. PAP adherence data will be downloaded from PAP machines (if available) for all subjects in both groups at baseline and at month 4.",[28],[525,63,526],"self-management","digital health","2026-03-20",{"date":466,"type":39},{"date":439,"type":22},{"date":531,"type":22},"2027-03-31",{"name":533,"class":46},"Hong Kong Metropolitan University",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":23,"phases":542,"briefSummary":543,"conditions":544,"keywords":545,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":75},"100615462","digital-supported-orofacial-myofunctional-therapy-in-osa-100615462","NCT07292922","Digital-supported Orofacial Myofunctional Therapy in OSA","Digital-supported Orofacial Myofunctional Therapy in Subjects With Obstructive Sleep Apnoea: A Pilot Randomised Control Trial","Inclusion Criteria:\n\n* Adults aged 18 years and above\n* Diagnosed with mild to moderate Obstructive Sleep Apnoea, defined as: Apnoea-Hypopnea Index of 5-30 events per hour\n* Indications for Continuous Positive Airway Pressure or oral appliance treatment, but unable to tolerate or decline these treatments\n* Body Mass Index less than 30 kg\u002Fm2\n\nExclusion Criteria:\n\n* Presence of obstructive nasal disease or significant nasal obstruction\n* Unstable mental health issues\n* History of stroke\n* Unstable chronic respiratory, cardiac, neurological conditions\n* Inability to provide informed consent\n* Prior oral, pharyngeal, or maxillofacial surgical therapy for sleep apnoea",{"count":161,"type":22},[58],"This pilot study explores the feasibility, acceptability, and preliminary effectiveness of Digital-supported Orofacial Myofunctional Therapy (d-MFT), an innovative program combining facial recognition technology with evidence-based orofacial exercises for individuals with mild to moderate obstructive sleep apnoea (OSA). The d-MFT program aims to strengthen oropharyngeal muscles, improve airway function, and reduce OSA severity.\n\nParticipants receiving 3-month d-MFT (n=30) are expected to demonstrate greater improvements in OSA severity, sleep-related symptoms, and quality of life compared to those in the waitlist control group (n=30).\n\nFeasibility and acceptability will be evaluated through outcome-based questionnaires and semi-structured interviews to explore participants' experiences, satisfaction, and perceived barriers to adherence.",[28],[546],"Orofacial Myofunctional Therapy","2026-03-11",{"date":549,"type":39},"2026-03-13",{"date":551,"type":39},"2026-01-05",{"date":553,"type":22},"2027-04-30",{"name":533,"class":46},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":157,"sex":18,"minAge":561,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":567,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":75},"100628841","effects-of-frequency-adjustment-in-functional-electrical-stimulation-on-genioglossus-muscle-activity-100628841","NCT07466888","Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* STOP questionnaire score ≥ 2\n* Able to read and write in Korean\n* Voluntarily provides written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Refusal to undergo study procedures or failure to provide informed consent\n* Cognitive impairment or psychiatric disorders that interfere with the ability to follow study instructions\n* Pregnant or breastfeeding women\n* Known allergy or hypersensitivity to electrical stimulation pads or related materials (e.g., silicone, polypropylene, polyethylene)\n* Skin conditions preventing application of electrical stimulation (e.g., hypersensitive skin)\n* Medical conditions considered unsuitable for participation by the investigator (e.g., epilepsy, malignant tumor, high fever, diabetes mellitus, use of anticoagulants, phlebitis, thrombophlebitis, hemophilia)\n* Infectious disease or local conditions at the stimulation site (e.g., inflammation, wounds, abscess, edema)\n* Known cardiac disease or presence of a cardiac pacemaker or implanted electrical stimulation device\n* History of surgery involving the submental area or upper airway region","19 Years",{"count":563,"type":22},28,[58],"This single-group interventional study investigates the safety and physiologic effects of functional electrical stimulation (FES) applied to the tongue and submental muscles in adults at high risk for sleep apnea. Participants will receive five stimulation frequencies (15, 25, 35, 45, and 75 Hz) in randomized order during a single visit. Ultrasound and tongue pressure (IOPI) measurements, as well as subjective assessments of discomfort and perceived effects, will be conducted before, during, and after stimulation. The primary objective is to evaluate changes in muscle thickness, length, and tongue strength across different stimulation frequencies. Secondary objectives include assessing participant discomfort, safety, and subjective treatment effects.",[28,299],[28,299,568],"FES","2026-03-08",{"date":571,"type":39},"2026-03-12",{"date":573,"type":39},"2026-01-06",{"date":575,"type":22},"2026-04",{"name":577,"class":46},"Seoul National University Bundang Hospital",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":75},"100628639","telemonitoring-with-cpap-in-severe-obstructive-sleep-apnea-in-primary-health-care-100628639","NCT07464262","Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care","Efficacy of Telemonitoring With CPAP in Severe Obstructive Sleep Apnea: A Randomized Controlled Trial in Primary Health Care","CPAP-APS","Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Diagnosis of severe obstructive sleep apnea (OSA) confirmed by polysomnography with apnea-hypopnea index (AHI) ≥30 events\u002Fhour.\n* New CPAP users (≤30 days since initiation of CPAP therapy).\n* Resident within the coverage area of the Southeast Regional Health Coordination (CRS Sudeste), São Paulo, Brazil.\n* Ability to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* Previous CPAP use for more than 30 days prior to enrollment.\n* Indication for bilevel ventilation (BiPAP) or non-invasive ventilation due to conditions such as hypoventilation syndromes, chronic hypercapnic COPD, or neuromuscular diseases.\n* Predominant central sleep apnea (≥50% central events) or Cheyne-Stokes respiration.\n* Recent unstable or severe comorbidity (e.g., decompensated heart failure, acute coronary syndrome within 30 days, stroke within 3 months).\n* Severe cognitive impairment or psychiatric disorder that prevents understanding of study procedures or adherence.\n* Conditions preventing safe use of CPAP mask (e.g., major craniofacial deformities, facial trauma, extensive facial skin lesions).\n* Inability to maintain follow-up in primary care services of CRS Sudeste.\n* Participation in another interventional clinical trial that may interfere with study outcomes.","75 Years",{"count":427,"type":22},[58],"Obstructive sleep apnea (OSA) is a prevalent sleep disorder associated with cardiovascular, metabolic, cognitive, and psychological complications. Continuous Positive Airway Pressure (CPAP) therapy is the gold standard treatment for moderate to severe OSA; however, long-term adherence remains a major challenge, particularly in real-world primary care settings.\n\nThis study aims to evaluate the effectiveness of telemonitoring using CPAP devices in improving treatment adherence and clinical outcomes among patients with severe OSA receiving care within the Brazilian Primary Health Care system.\n\nThis randomized controlled trial will include 200 adult participants with severe OSA who are new users of CPAP therapy and are followed by primary health care units in the Southeast Regional Health Coordination of São Paulo, Brazil. Participants will be randomly allocated into two groups: a telemonitoring intervention group, monitored remotely through the AirView® platform and the myAir® application, and a control group receiving standard care without telemonitoring.\n\nPrimary outcomes include CPAP adherence and residual apnea-hypopnea index (AHI). Secondary outcomes include daytime sleepiness, sleep quality, mood, cognitive complaints, and patient perceptions of care. Quantitative clinical data will be collected through CPAP telemonitoring systems and standardized questionnaires, while qualitative data will be obtained through semi-structured interviews with patients and health professionals.\n\nThe results of this study may provide evidence supporting the integration of digital health technologies into primary health care services to improve adherence to CPAP therapy and optimize the management of obstructive sleep apnea in public health systems.",[28],[592],"CPAP Obstructive Sleep Apnea Telemonitoring Digital Health Sleep Apnea Primary Health Care Adherence Remote Monitoring","2026-03-06",{"date":547,"type":39},{"date":596,"type":39},"2025-10-06",{"date":598,"type":22},"2027-07",{"name":600,"class":46},"Federal University of São Paulo",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":586,"enrollmentInfo":608,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":610,"conditions":611,"keywords":612,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":75},"100627389","multimodal-deep-learning-model-for-predicting-the-apnea-hypopnea-index-in-obstructive-sleep-100627389","NCT07447999","Multimodal Deep Learning Model for Predicting the Apnea-Hypopnea Index in Obstructive Sleep","A Multisensor Deep Neural Framework Combining Digital Auscultation, Oxygen Saturation, and Motion Data to Estimate the Apnea-Hypopnea Index in Obstructive Sleep Apnea","Inclusion Criteria:\n\n* age 30-75 years\n* clinically suspected obstructive sleep apnea and scheduled for polysomnography\n* willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* intolerance to the electronic stethoscope or fingertip pulse oximeter\n* significant structural airway abnormalities\n* arrhythmia\n* neuromuscular disorders\n* pregnancy\n* hospitalization within the past 1 month\n* inability to provide informed consent or requiring legal guardian consent",{"count":609,"type":22},150,"This study aims to develop a multimodal deep learning model that integrates noninvasive signals to predict the severity of obstructive sleep apnea. By establishing a clinically viable and user-friendly monitoring tool, the study seeks to enhance early screening accessibility and support the development of home-based sleep care systems.",[28,132],[241,613,614,615,616],"polysomnography","ballistocardiography","electronic stethoscope","oxygen saturation","2026-03-03",{"date":619,"type":39},"2026-03-05",{"date":621,"type":39},"2025-09-05",{"date":623,"type":22},"2026-07-31",{"name":625,"class":46},"Fu Jen Catholic University",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":157,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":632,"targetDuration":634,"studyType":162,"phases":4,"briefSummary":635,"conditions":636,"keywords":637,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":650},"100626229","evaluation-of-the-diagnostic-capacity-of-a-smart-mattress-versus-conventional-polysomnography-100626229","NCT07432919","Evaluation of the Diagnostic Capacity of a Smart Mattress Versus Conventional Polysomnography","Inclusion Criteria:\n\n* Polysomnographies performed at San Pedro Hospital between November 17, 2026, and March 1, 2028.\n* Polysomnographies of patients under 16 years of age and polysomnographies performed at San Pedro Hospital on patients over 16 years of age (as separate study groups).\n\nExclusion Criteria:\n\n* Poor technical quality of the polysomnography.\n* Patients with \\>50% central apneas or presence of Cheyne-Stokes respiration (CSResp).\n* Lack of polysomnography analysis and\u002For mattress data.",{"count":633,"type":22},500,"1 Day","This project aims to develop and evaluate an innovative, non-invasive diagnostic system based on a smart mattress for detecting obstructive sleep apnea (OSA), as well as assessing overall sleep quality and identifying periodic limb movements. The main goal is to improve the accuracy of sleep apnea diagnosis while providing a less invasive solution suitable for home use, ultimately enhancing patients' quality of life.\n\nA descriptive, observational, prospective study will be conducted to analyze data obtained from diagnostic polysomnographies performed at the Sleep Unit of San Pedro Hospital between November 17, 2026, and March 1, 2028. Patients will use the smart mattress, and its measurements will be compared with polysomnography results. This comparison will allow for the optimization of the mattress's artificial intelligence, training it to accurately recognize respiratory patterns and sleep-related events, including positional apneas and periodic limb movements.\n\nKey technical objectives include:\n\nDetermining the sensitivity, specificity, and predictive values of the mattress in detecting apneas, hypopneas, and limb movements compared to polysomnography.\n\nEvaluating the agreement between the mattress and polysomnography for sleep variables such as total sleep time, sleep efficiency, sleep stages, micro-arousals, and patient position.\n\nAssessing whether measurement accuracy varies by sleeping position or age group (adults vs. children).\n\nMeasuring subjective sleep quality using the Groningen Sleep Quality Scale (GSQS-8).\n\nPerforming a descriptive analysis of patient demographics.\n\nHypotheses:\n\nThe smart mattress will detect obstructive sleep apnea, sleep quality, and periodic limb movements with accuracy comparable to polysomnography.\n\nThe system will provide a reliable, non-invasive, home-friendly diagnostic method.\n\nMeasurements of the apnea-hypopnea index (AHI) and limb movements will show high sensitivity, specificity, and predictive values, both overall and according to OSA severity.\n\nThere will be good agreement between mattress measurements and polysomnography for most sleep variables.\n\nAccuracy may vary depending on the patient's sleeping position.\n\nMeasurements will correlate well across adults and pediatric patients.\n\nSubjective sleep quality scores (GSQS-8) will be consistent with objective mattress data.\n\nThis project seeks to develop a more accurate, accessible, and non-invasive diagnostic system for OSA, combining advanced technology with ease of home use. By training the mattress's AI to recognize sleep patterns and events, it aims to optimize the detection of positional apneas, providing patients with better monitoring, early intervention, and improved quality of life.",[28],[638,639,640,641,28],"Smart mattress","Sleep diagnosis","Artificial intelligence in healthcare","Sleep treatment innovation","2026-02-27",{"date":617,"type":39},{"date":645,"type":22},"2026-11-17",{"date":647,"type":22},"2028-03-01",{"name":649,"class":46},"Hospital San Pedro de Logroño",2,{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":661,"briefSummary":662,"conditions":663,"keywords":664,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":650},"100627334","the-improving-sleep-in-african-american-couples-study-isaac-100627334","NCT07447284","The Improving Sleep in African American Couples Study (ISAAC)","The Improving Sleep in African American Couples (ISAAC) Study","ISAAC","Inclusion Criteria - Patient:\n\n* Moderate or severe OSA (Apnea hypopnea index ≥ 15 events\u002Fhour)\n* Age ≥ 30 years\n* Bed partner for ≥ last 6 months who is willing to participate\n* English proficient\n\nInclusion Criteria - Bed Partner\n\n* Bed partner for ≥ 6 months and willing to participate\n* English proficient\n\nExclusion Criteria - Patient:\n\n* Terminal illness\n* Neurocognitive disorder that prevents informed consent\n* Unstable housing\n* Need for other forms of positive airway pressure (BPAP or VPAP)\n* Pregnancy",{"count":660,"type":22},440,[58],"The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple therapy, and couple-oriented peer support) on continuous positive airway pressure (CPAP) adherence, quality of sleep, functional status, and quality of life among patients with obstructive sleep apnea (OSA) and their bed partners.",[28],[665,666,667],"Sleep Apnea Syndromes\u002FTherapy","Continuous Positive Airway Pressure","Couples Therapy","2026-02-26",{"date":617,"type":39},{"date":671,"type":22},"2026-03-01",{"date":673,"type":22},"2028-07",{"name":675,"class":46},"MetroHealth Medical Center"]