[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"otitis-media-effusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:otitis-media-effusion":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,76,99,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100642730","osteopathic-manipulative-treatment-for-children-with-chronic-or-recurrent-otitis-media-100642730",false,"NCT07639775","Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media","The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 6 months to less than 7 years. (All participants)\n* Referred to an otolaryngologist (ENT) for evaluation of chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). (All participants)\n* Planned for tympanostomy tube placement (unilateral or bilateral) pending surgical decision. (All participants)\n* At least 5 weeks between enrollment and anticipated surgical decision point. (All participants)\n\nExclusion Criteria:\n\n* Congenital or developmental conditions associated with increased otitis media risk, including but not limited to Down syndrome, cleft palate, or other craniofacial abnormalities. (All participants)\n* History of prior tympanostomy tube placement or current tympanostomy tubes in place. (All participants)\n* History of tympanic membrane perforation. (All participants)\n* Presence of preauricular pits. (All participants)\n* Patients requiring urgent or expedited surgical intervention, as determined by the treating ENT physician. (All participants)","ALL","6 Months","6 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement.\n\nThe main question it aims to answer is:\n\nCan a standardized OMT protocol, given once weekly for 4 weeks before the final surgical decision, reduce the rate of tympanostomy tube surgery in pediatric patients with recurrent or chronic otitis media?\n\nResearchers will compare children who receive the standardized OMT protocol with children who receive a placebo\u002Fcontrol manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery.\n\nParticipants will:\n\n* Attend 4 weekly study visits before their final ENT surgical decision.\n* Receive one of several assigned combinations of standardized OMT intervention procedures and control manual procedures. Each participant's assigned treatment sequence is determined by randomization.\n* Complete study-related assessments and questionnaires related to ear symptoms and quality of life.\n* Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.",[27,28,29,30,31,32,33,34],"Otitis Media","Otitis Media Effusion","Otitis Media Recurrent","Otitis Media With Effusion in Children","Otitis Media Chronic","Otitis Media in Children","Tympanostomy Tube Insertion","Osteopathic Manipulative Treatment (OMT)","NOT_YET_RECRUITING","2026-06-06",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":21},"2026-08-01",{"date":43,"type":21},"2028-05-31",{"name":45,"class":46},"Sarah Vidal","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100639335","clikx-tympanostomy-tube-delivery-system-for-the-placement-of-tympanostomy-tubes-100639335","NCT07625657","CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes","A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes","Inclusion Criteria:\n\n1. Subject is scheduled to undergo tympanostomy tube insertion.\n2. Subject is ≥ 6 months old at the time of informed consent.\n3. Subject has an ear canal diameter of ≥ 4 mm.\n4. Subject is able and willing to provide informed consent or subject's parent\u002Fguardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to 21 years old).\n\nExclusion Criteria:\n\n1. Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice.\n2. Subjects with known adverse reaction to anesthesia.\n3. Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.\n4. Subjects with otitis externa.\n5. Subjects with active acute otitis media.\n6. Subjects with an ear canal diameter \\\u003C 4 mm.\n7. Ear drums that are overly vertical or horizontal\n8. Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.\n9. Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk.\n10. Subjects with suspected middle ear tumors or vascular lesions.\n11. Subjects diagnosed with acute sensorial hearing loss\n12. Subjects with a history of surgery involving the ear drum.\n13. Subjects with hemotympanum.\n14. Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.",{"count":56,"type":21},80,[24],"This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed.\n\nIn this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia.\n\nThe study will also look at how well patients tolerate the procedure by checking for side affects during the procedure.\n\nFinally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..",[27,31,28,29,32],[61,62,63,64,65],"otitis media","Tympanostomy tube","NousQ","CLiKX","myringotomy","2026-06-02",{"date":68,"type":39},"2026-06-04",{"date":70,"type":21},"2026-06",{"date":72,"type":21},"2027-08",{"name":74,"class":75},"ClinQure, Inc.","NETWORK",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100611631","validating-and-ai-software-for-assessment-of-children-with-ear-concerns-100611631","NCT07243093","Validating and AI Software for Assessment of Children With Ear Concerns","Validating a Deep Learning Algorithm in Children With Ear Concerns","Inclusion Criteria:\n\n* Males and females aged 6 months to 6 years\n* Presenting to a pediatrician's office or urgent care with signs and symptoms of otitis media, including tugging at ears, ear pain, crying at night, refusing to lie flat, sleeping poorly, having a fever, having decreased appetite, and\u002For concern for hearing loss, regardless of previous diagnosis of AOM or OME.\n\nExclusion Criteria:\n\n* History of craniofacial abnormality\n* PE tubes currently in place\n* Current otorrhea\n* Caretaker not having use of both hands and arms",{"count":84,"type":21},658,"OBSERVATIONAL","The goal of this observational study is to determine if the Glimpse machine learning algorithm can accurately assess ear diseases in children. Participants will:\n\n* Have a video of their ear taken by their parent or their guardian\n* Have a video of their ear taken by a Primary Care Physician (PCP)\n* Have an assessment of their eardrums and a video of their ears taken by an Ear, Nose, and Throat specialist (ENT).\n\nThe videos will be used to determine if the Glimpse algorithm matches the diagnosis of the physicians.",[88,27,28],"Otalgia","2025-11-17",{"date":91,"type":39},"2025-11-21",{"date":93,"type":21},"2026-01",{"date":95,"type":21},"2027-07",{"name":97,"class":98},"Glimpse Diagnostics, Inc.","INDUSTRY",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100611897","gamified-training-and-ai-support-for-improving-ear-infection-diagnosis-in-primary-care-100611897","NCT07246551","Gamified Training and AI Support for Improving Ear Infection Diagnosis in Primary Care","Enhancing Diagnosis of Otitis Media in Primary Care: Gamified Training and AI-Driven Tools","Inclusion Criteria Patients:\n\n* Newly developed ear discomfort or symptoms within the past month. The patient seeks care at a participating primary care centre and is assessed by a physician because of these ear-related symptoms. Alternatively, for young children: respiratory tract infection with concurrent signs or symptoms suggesting possible ear involvement, even if the child cannot clearly express ear pain.\n* Age: Children and adults of all ages are eligible to participate.\n* Informed consent: The patient (or guardian for minors) agrees to participate and provides written informed consent. For children under 15 years, consent is obtained from both guardians before any data storage.\n* The patient must have been managed by a physician who has consented to participate in the study (as a physician participant) and who is a GP specialist, GP resident, or junior physician (intern or basic training physician) working at the primary care centre.\n* At intervention centres, the managing physician must have completed the AOM Diagnosis (Dx) Trainer and reached the required score threshold (\"diploma\") before including patients.\n\nInclusion Criteria Physicians:\n\n* General practitioners (GP specialists), GP residents, or junior physicians (interns or basic training physicians) working clinically at participating primary care centres.\n* Have provided written informed consent to participate in the study as physician participants.\n* At intervention centres, must have completed the AOM Dx Trainer and achieved the required diploma level before patient inclusion.\n* At control centres, receive no access to the AOM Dx Trainer during the study period.\n\nExclusion Criteria:\n\n* Withdrawal of consent by the participant (physician or patient).",{"count":20,"type":21},[24],"Acute otitis media (AOM), or middle ear infection, is one of the most common childhood infections and a leading cause of antibiotic prescribing in primary care. Diagnosing AOM can be challenging, as ear symptoms and eardrum appearances often overlap with mild or transient conditions. This uncertainty may lead to both unnecessary antibiotic use and missed cases requiring treatment, affecting patient safety and contributing to antibiotic resistance.\n\nThis study evaluates two digital tools designed to support more accurate diagnosis and treatment decisions in primary care:\n\n1. AOM Dx \\[diagnosis\\] Trainer (Otitspelet) - a gamified digital training program for physicians that provides interactive exercises using eardrum images and patient cases, with direct feedback to improve diagnostic accuracy and adherence to guidelines.\n2. AI-based diagnostic support - a system that analyses tympanic membrane images, with and without symptom and tympanometry data, to evaluate its potential for future diagnostic use.\n\nThe trial is coordinated by the Västra Götaland Region (VGR) in collaboration with Umeå University and conducted across four Swedish regions: Västra Götaland, Västerbotten, Östergötland, and Skåne. VGR leads the evaluation of the AOM Dx Trainer intervention, while Umeå University leads the AI development and retrospective diagnostic analyses. The study is carried out as a multicentre, cluster-randomised controlled trial in primary care, where participating primary care centres are randomised to either the training intervention or standard care.\n\nPhysicians are the research participants under evaluation. At intervention centres, physicians complete training with the AOM Diagnosis (Dx) Trainer before study start; at control centres, no training is provided. Each participating centre then conducts an 8-week observation period, during which physicians diagnose and manage patients with new-onset ear symptoms. Patients are included only to allow evaluation of physicians' diagnostic and treatment decisions and to provide data for AI analysis. Estimated patient enrollment is \\~200. Depending on centre size and recruitment success, up to 20 primary care centres across four Swedish regions - Västra Götaland, Västerbotten, Östergötland, and Skåne - will participate. After each consultation, research nurses collect tympanic membrane images and tympanometry data from patients who have given informed consent. These data are used for expert panel reference diagnoses and retrospective AI analysis; no information is shared with treating physicians.\n\nThe primary outcome is diagnostic accuracy of tympanic membrane assessment by physicians trained with the AOM Dx Trainer compared with untrained physicians, using expert consensus as the reference standard. Secondary outcomes include adherence to treatment guidelines and antibiotic prescribing rates. The AI system's diagnostic performance will also be benchmarked against the expert panel and physician groups.\n\nBy combining educational and technological innovation, this study aims to enhance diagnostic precision, improve guideline adherence, and reduce unnecessary antibiotic use in primary care-strengthening antimicrobial stewardship and providing a scalable model for future infection management.",[110,28],"Otitis Media Acute",[27,112,113,114,115],"Primary Health Care","Artificial Intelligence","Antimicrobial Stewardship","Clinical Decision Support Systems",{"date":117,"type":39},"2025-11-24",{"date":119,"type":21},"2025-12-01",{"date":121,"type":21},"2027-12-31",{"name":123,"class":124},"Vastra Gotaland Region","OTHER_GOV",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":47},"100588699","swir-otoscopy-study-100588699","NCT06944795","SWIR Otoscopy Study","A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis","Inclusion Criteria:\n\n* Ages 1-17\n* Being seen in the Ear, Nose, and Throat Clinic at Lucile Packard Childrens Hospital\n* Undergoing tympanostomy tube placement as part of standard of care\n* Parents and\u002For patient has the ability to understand and the willingness to sign a written informed consent form or assent form.\n\nExclusion Criteria:\n\n* Patients under 1 year of age or 18 and older\n* Participants not meeting the inclusion criteria","1 Year","17 Years",{"count":135,"type":21},100,[24],"The aim of this study is to provide preliminary data to support future studies to demonstrate that the short wave infrared (SWIR) otoscope is a better diagnostic tool than a white light otoscope for diagnosing middle ear infections (otitis media). Patients who are having a tympanostomy tube placement procedure will be participating in this study. Imaging will be performed with the white light otoscope and the SWIR otoscope to determine presence of absence of fluid. The SWIR otoscope will gather SWIR data and white light data simultaneously. As part of standard of care, patients who come in for this procedure have removal of middle ear fluid as part of their procedure, which will confirm presence or absence of fluid.",[27,31,28],[140,141,142,61,143,144],"middle ear infections","ear infections","pediatric ear infections","chronic otitis media","chronic otitis media with effusion","2025-04-25",{"date":147,"type":39},"2025-04-30",{"date":149,"type":21},"2025-05-01",{"date":151,"type":21},"2027-01",{"name":153,"class":46},"Stanford University"]