[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654124":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":39,"studyPopulation":32,"armGroups":40,"interventions":47,"overallOfficials":55,"centralContacts":59,"locations":69,"responsibleParty":88,"collaborators":32,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":32,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":32,"enrollmentInfo":100,"targetDuration":32,"studyType":103,"phases":104,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":72,"whyStopped":32,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) score","The PHI-10 is a 10-item validated patient-reported instrument measuring symptom burden in patulous Eustachian tube. Total scores range from 0 to 40, with lower scores indicating fewer symptoms. The outcome is the change in total score from baseline to the follow-up visit.","Baseline and 3 to 4 weeks",[14,18,22,26,29],{"measure":15,"description":16,"timeFrame":17},"Acute change in PHI-10 score after first device application","Change in PHI-10 total score from baseline to 10 minutes (±5 minutes) after the participant first applies the nasal dilator, assessing immediate symptom response. Scores range 0 to 40; lower is better.","Baseline and 10 minutes after first application",{"measure":19,"description":20,"timeFrame":21},"Adherence to device wear","Self-reported average hours of device wear per day and percentage of prescribed days on which the device was worn, collected at the follow-up visit.","Baseline through 3 to 4 weeks",{"measure":23,"description":24,"timeFrame":25},"Device usability and acceptability","Participant ratings of comfort, ease of use, and willingness to continue use, each scored on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating greater acceptability.","3 to 4 weeks",{"measure":27,"description":28,"timeFrame":25},"Global Rating of Change","Single-item participant-reported rating of overall change in symptoms since baseline, collected at the follow-up visit.",{"measure":30,"description":31,"timeFrame":21},"Number of participants with device-related adverse events","Count of participants experiencing device-related adverse events, including nasal irritation, pressure discomfort, and epistaxis. Assessed at first wear, at the follow-up visit, and by interim report between visits.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"NA","SINGLE_GROUP","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE","This is a single-arm, prospective, pre\u002Fpost pilot study of a commercially available internal nasal dilator (Airmax) in adults with clinically confirmed patulous Eustachian tube dysfunction and a positive Cottle maneuver. Symptom burden is measured with the Patulous Eustachian Tube Handicap Inventory-10 (PHI-10) at baseline, 10 minutes after first device application, and at a 3-4 week follow-up visit. The study is intended to generate effect-size estimates to inform the design of subsequent controlled trials. The device is over-the-counter, 510(k)-exempt, used without modification, and the study is exempt from IDE requirements under 21 CFR 812.2(c).",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Internal Nasal Dilator","EXPERIMENTAL","Participants receive a commercially available internal nasal dilator (Airmax) at the baseline clinic visit, along with sizing, fitting, and hygiene instruction from trained study staff. Participants apply the device during the visit and continue at-home use per the study wear schedule until the follow-up visit approximately 3 to 4 weeks later.",[46],"Device: Internal nasal dilator",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DEVICE","Internal nasal dilator","Single-patient-use, over-the-counter internal nasal dilator worn inside the nasal vestibule to laterally support the nasal valve and increase nasal cross-sectional area. Devices are supplied in sealed retail packaging without modification. Participants wear the device per the prescribed schedule from the baseline visit until the follow-up visit at 3 to 4 weeks.",[42],[54],"Airmax Nasal Dilator",[56],{"name":57,"affiliation":5,"role":58},"Jeffrey Vrabec, MD","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":32,"email":64},"Stephanie Camey, BA","CONTACT","8327068834","scamey@houstonmethodist.org",{"name":66,"role":62,"phone":67,"phoneExt":32,"email":68},"Roger Neuberger, BS","361-945-1327","rneuberger@houstonmethodist.org",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Houston Methodist Hospital - Department of Otolaryngology-Head & Neck Surgery","RECRUITING","Houston","Texas","77030","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-95.36327,29.76328,{"lat":82,"lon":81},[85,86,87],{"name":61,"role":62,"phone":63,"phoneExt":32,"email":64},{"name":66,"role":62,"phone":67,"phoneExt":32,"email":68},{"name":57,"role":58,"phone":32,"phoneExt":32,"email":32},{"type":58,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Vrabec, Jeffrey M.D.","Professor of Otolaryngology-Head and Neck Surgery","100654124","nasal-dilator-therapy-for-patulous-eustachian-tube-dysfunction-100654124",false,"NCT07796139","Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction","Prospective PI-Initiated Study of Nasal Dilator Therapy in Patulous Eustachian Tube Dysfunction","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Treated by a clinician in the Houston Methodist Department of Otolaryngology - Head and Neck Surgery\n* Positive response to the Cottle maneuver\n* Able and willing to provide informed consent\n* Able to complete study surveys\n* Willing to avoid starting new therapies directed at patulous Eustachian tube during the study window unless medically necessary\n\nExclusion Criteria:\n\n* Active middle-ear disease at screening\n* Significant nasal pathology precluding safe use of a nasal dilator\n* Known intolerance or hypersensitivity to nasal dilators\n* Any condition judged by the investigator to increase risk or confound assessments\n* Unable to provide informed consent\n* Cognitive impairment preventing completion of study surveys\n* Non-English speaking, as the PHI-10 and study materials are currently available only in English\n* Pregnant\n* Prisoner","ALL","18 Years",{"count":101,"type":102},50,"ESTIMATED","INTERVENTIONAL",[34],"The Eustachian tube connects the middle ear to the back of the nose and throat, providing ventilation of the middle ear. People with a patulous Eustachian tube perceive the tube stays open continuously. This can make a person's own voice and breathing sound unusually loud in the ear and can cause a feeling of fullness or blocked hearing. There is currently no agreed-upon first treatment for these symptoms.\n\nSome people with this condition notice their symptoms improve when they gently pull the cheek outward to widen the nasal passage. A nasal dilator is a small, soft device worn just inside the nostrils that does something similar by holding the nasal passage more open. Nasal dilators are sold over the counter and are commonly used for stuffy nose and snoring. They have not been studied as a treatment for patulous Eustachian tube.\n\nThis study will look at whether wearing a nasal dilator reduces symptoms in adults with patulous Eustachian tube. About 50 adults treated at Houston Methodist will take part. Everyone in the study receives the nasal dilator; there is no placebo or comparison group.\n\nParticipants complete a 10-question symptom survey before using the device, again 10 minutes after putting it in for the first time, and once more at a follow-up clinic visit about 3 to 4 weeks later. Between visits, participants wear the device at home and keep track of how often they use it. At the follow-up visit they also answer questions about whether the device was comfortable and easy to use, and whether they had any side effects. Participation lasts about 3 to 4 weeks.",[107,108],"Patulous Eustachian Tube Dysfunction","Eustachian Tube Dysfunction",[110,111,112,113,114,115,116],"patulous eustachian tube","PET","nasal dilator","Cottle maneuver","autophony","PHI-10","nasal valve","2026-08-25",{"date":119,"type":120},"2026-08-31","ACTUAL",{"date":122,"type":120},"2026-04-22",{"date":124,"type":102},"2027-04-22",{"name":5,"class":6},1]