[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580419":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":42,"locations":48,"responsibleParty":63,"collaborators":32,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":32,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":32,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":92,"whyStopped":32,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"The Conventional Olfactory Training Group","ACTIVE_COMPARATOR","Patients are instructed to use the conventional olfactory training device at home twice daily, before breakfast and at bedtime. Four odors will be used: rose, mint, lemon, and clove. In each training session, participants are exposed to each odor for a duration of 10 seconds, followed by a 10-second break before the next odor is presented. Each training session lasts 5 minutes and is conducted for a duration of 12 months. All the patients will be treated with budesonide irrigations. Saline irrigations will be administered twice daily for 12 months using a NeilMed™ (NeilMed, Santa Rosa, CA) squeeze bottle along with salt packets and either distilled or filtered water. 2 mL of 0.5 mg\u002F 2 mL budesonide (Pulmicort Respules, AstraZeneca Canada, Mis sissauga, ON, Canada) will be added to the irrigation bottles of the patients.",[13],"Device: Conventional olfactory training device",{"label":15,"type":16,"description":17,"interventionNames":18},"The Modified Olfactory Training Group","EXPERIMENTAL","Patients are instructed to use a modified olfactory training device based on expiratory pressure at home twice daily, before breakfast and at bedtime. Four odors will be used: rose, mint, lemon, and clove. In each training session, participants are exposed to each odor for a duration of 10 seconds, followed by a 10-second break before the next odor is presented. Each training session lasts 5 minutes and is conducted for a duration of 12 months. All the patients will be treated with budesonide irrigations. Saline irrigations will be administered twice daily for 12 months using a NeilMed™ (NeilMed, Santa Rosa, CA) squeeze bottle along with salt packets and either distilled or filtered water. 2 mL of 0.5 mg\u002F 2 mL budesonide (Pulmicort Respules, AstraZeneca Canada, Mis sissauga, ON, Canada) will be added to the irrigation bottles of the patients.",[19],"Device: Modified olfactory training device",{"label":21,"type":22,"description":23,"interventionNames":24},"The Control Group","SHAM_COMPARATOR","Participants will not receive any olfactory training. All the patients will be treated with budesonide irrigations. Saline irrigations will be administered twice daily for 12 months using a NeilMed™ (NeilMed, Santa Rosa, CA) squeeze bottle along with salt packets and either distilled or filtered water. 2 mL of 0.5 mg\u002F 2 mL budesonide (Pulmicort Respules, AstraZeneca Canada, Mis sissauga, ON, Canada) will be added to the irrigation bottles of the patients.",[25],"Drug: Budesonide irrigation",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Conventional olfactory training device","Four odorants are used: phenyl ethyl alcohol (PEA): rose, menthol: mint, citronellal: lemon, and eugenol: cloves. Training patients will receive four glass vials. Each contains one odorant (5 mL, soaked in cotton pads to prevent spilling) and is labeled with the name of the odorant.\n\nBudesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Modified olfactory training device","The modified olfactory training device is based on the nasal bidirectional drug delivery system. The device uses breathing pressure to create positive pressure, significantly increasing the deposition rate of odors in the olfactory cleft area.\n\nBudesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.",[15],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"DRUG","Budesonide irrigation","Budesonide irrigation can effectively target the olfactory cleft area to provide anti-inflammatory effects.",[21],[43],{"name":44,"role":45,"phone":46,"phoneExt":32,"email":47},"Dawei Wu, MD, PhD","CONTACT","13522503401","davidwuorl@163.com",[49],{"facility":50,"status":32,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Beijing","Beijing Municipality","100191","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},[62],{"name":44,"role":45,"phone":46,"phoneExt":32,"email":47},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Dawei Wu","Associate Researcher","100580419","the-effect-of-modified-olfactory-training-on-postoperative-olfactory-dysfunction-in-patients-with-crs-100580419",false,"NCT06837051","The Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With CRS","Protocol for a Randomized Controlled Trial Evaluating the Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With Chronic Rhinosinusitis","Inclusion Criteria:\n\n1. A diagnosis of CRSsNP based on the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS20).\n2. The duration after endoscopic sinus surgery is 3months.\n3. Olfactory dysfunction confirmed with the Sniffin's Sticks psychophysical test (TDI score≦30.5) .\n4. Willingness to participate in this study and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Patients with olfactory impairment due to traumatic, congenital, toxic\u002Fdrug-induced causes, tumors, or post-upper respiratory infections.\n2. Lund-Mackay olfactory cleft score \\> 0.\n3. Patients with severe comorbidities, such as malignant tumors.\n4. Current or planned pregnancy prior to the end of study.\n5. Patients who are unable to complete the study or are unable to comply with the requirements of the study (such as inability to tolerate olfactory function testing and treatment, memory or behavioral abnormalities, depression, smoking, heavy alcohol use, previous delinquent behavior)","ALL","18 Years","80 Years",{"count":78,"type":79},213,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:\n\nIs it possible that the device can treat postoperative olfactory dysfunction in patients with chronic sinusitis? Compared to the conventional device, how efficient is the modified olfactory training device for treating postoperative olfactory dysfunction in patients with chronic sinusitis?",[85,86],"Olfactory Dysfunction","Chronic Rhinosinusitis",[88,89,90,91],"olfactory dysfunction","chronic rhinosinusitis","endoscopic sinus surgery","olfactory training","NOT_YET_RECRUITING","2025-02-14",{"date":95,"type":96},"2025-02-20","ACTUAL",{"date":98,"type":79},"2025-03-14",{"date":100,"type":79},"2027-03-14",{"name":5,"class":6},1]